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Beneficial effects of an investigational wristband containing Synsepalum dulcificum (miracle fruit) seed oil on the performance of hand and finger motor skills in healthy subjects: A randomized controlled preliminary study

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Miracle fruit (Synsepalum dulcificum) seed oil (MFSO) contains phytochemicals and nutrients reported to affect musculoskeletal performance. The purpose of this study was to assess the safety and efficacy of a compression wristband containing MFSO on its ability to measurably improve the hand and finger motor skills of participants. Healthy right-handed participants (n = 38) were randomized in this double-blind, placebo-controlled study of MFSO and vehicle wristbands. Subjects wore the wristband on their left hand 4–6 weeks and then only on their right hand 2–4 weeks; the contralateral untreated hand served as an additional control. Twelve hand/finger motor skills were measured using quantitative bio-instrumentation tests, and subject self-assessment questionnaires were conducted. With each hand, in 9/12 tests, the MFSO group showed a clinically meaningful average improvement compared with an average worsening in the vehicle group. Statistical superiority to the control treatment group was exhibited in 9/12 tests for each hand (p < .01). After discontinuing the MFSO wristband on the left hand, test values regressed toward baseline levels. Subjects favored the MFSO wristband over the control, rating it as effective in improving their motor skills. Use of the MFSO wristband may improve an individual's manual dexterity skills and ability to maintain this performance.
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RESEARCH ARTICLE
Beneficial effects of an investigational wristband containing
Synsepalum dulcificum (miracle fruit) seed oil on the
performance of hand and finger motor skills in healthy subjects:
A randomized controlled preliminary study
Steven Gorin
1
|Charles Wakeford
2
|Guodong Zhang
3
|Elvira Sukamtoh
3
|
Charles Joseph Matteliano
4
|Alfred Earl Finch
5
1
Institute of Sports Medicine and
Orthopaedics, Aventura Hospital, Aventura, FL
33180, USA
2
Triangle Biostatistics, Wake Forest, NC
27587, USA
3
Department of Food Science, University of
Massachusetts Amherst, Amherst, MA 01003,
USA
4
TEQ Solutions, Kenmore, NY 14217, USA
5
Department of Kinesiology, Recreation and
Sport, Indiana State University, Terre Haute,
IN 47809, USA
Correspondence
Steven Gorin, DO, MSEd, Institute of Sports
Medicine and Orthopaedics, 2260 NE 123rd
St, North Miami, FL 33181, USA.
Email: gorin@instituteofsports.com
Funding information
Miracle Fruit Oil Company, Grant/Award
Number: 02
Miracle fruit (Synsepalum dulcificum) seed oil (MFSO) contains phytochemicals and nutrients
reported to affect musculoskeletal performance. The purpose of this study was to assess the
safety and efficacy of a compression wristband containing MFSO on its ability to measurably
improve the hand and finger motor skills of participants. Healthy righthanded participants
(n= 38) were randomized in this doubleblind, placebocontrolled study of MFSO and vehicle
wristbands. Subjects wore the wristband on their left hand 46 weeks and then only on their right
hand 24 weeks; the contralateral untreated hand served as an additional control. Twelve
hand/finger motor skills were measured using quantitative bioinstrumentation tests, and subject
selfassessment questionnaires were conducted. With each hand, in 9/12 tests, the MFSO group
showed a clinically meaningful average improvement compared with an average worsening in the
vehicle group. Statistical superiority to the control treatment group was exhibited in 9/12 tests
for each hand (p< .01). After discontinuing the MFSO wristband on the left hand, test values
regressed toward baseline levels. Subjects favored the MFSO wristband over the control, rating
it as effective in improving their motor skills. Use of the MFSO wristband may improve an
individual's manual dexterity skills and ability to maintain this performance.
KEYWORDS
elastomeric MFSO wristband, hand and finger dexterity, miracle fruit seed oil, motor skill
performance, randomized controlled study, Synsepalum dulcificum
1|INTRODUCTION
Vegetable oils from plants and fruit seeds have been used for cosmetic
and medicinal purposes as part of human culture for millennia. The
ancient Greeks rubbed olive oil on the skin as an ergogenic aid during
athletic competition to reduce muscle fatigue and enhance a faster
recovery (Nomikos, Nomikos, & Kores, 2010). Synsepalum dulcificum
seed oil, commonly known as miracle fruit seed oil (MFSO), is a rare
and exotic fruit oil derived from the seed of the miracle fruit berry
(Guney & Nawar, 1977). The MFSO is an abundant source of phyto-
chemicals and essential nutrients that are known to regulate the phys-
iologic functions of cells (Inglett & Chen, 2011). At greater than 20% of
its weight, the bioactiverich unsaponifiable lipid fraction of the MFSO
is among the highest in content recorded for a crude fruit seed oil (Del
Campo, Zhang, & Wakeford, forthcoming). This fraction contains a
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This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided
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Copyright © 2017 The Authors Phytotherapy Research Published by John Wiley & Sons Ltd.
Abbreviations: MFSO, miracle fruit seed oil; FTT, finger tapping test; FTTEP,
finger tapping test explosive power; FTTA, finger tapping test acceleration;
FTTF, finger tapping test fatigue; PPT, Purdue Pegboard Test; HSTPT, Hand
Steadiness Tracing Pattern Test; HW, handwriting; GS, grip strength; PS, pinch
strength; GSF, grip strength fatigue; PSF, pinch strength fatigue; N, newtons;
ANOVA, analysis of variance.
Received: 25 July 2017 Revised: 1 October 2017 Accepted: 18 October 2017
DOI: 10.1002/ptr.5980
Phytotherapy Research. 2017;112. wileyonlinelibrary.com/journal/ptr 1
substantial amount of phytochemicals such as the polyphenols,
triterpenes, and phytosterols that exhibit antiinflammatory, antioxidant,
and regenerative activities (Wu et al., 2013; Thirupathi, Silveira, Nesi, &
Pinho, 2017; Loizou, Lekakis, Chrousos, & Moutsatsou, 2010; Lee et al.,
2014; Del Campo et al., forthcoming) and appear to be beneficial for
enhancing physical performance (Cases et al., 2017; Davis, Carlstedt,
Chen, Carmichael, & Murphy, 2010; Yarahmadi et al., 2014). Appreciable
quantities of essential nutrients are also present within the MFSO such
as linoleic acid, vitamin K, and elemental silicon (unpublished observations)
that can affect locomotor activity (Cocchetto, Miller, Miller, & Bjornsson,
1985; Raygada, Cho, & HilakiviClarke, 1998) and musculoskeletal health
and homeostasis (Rodella, Bonazza, Labanca, Lonati, & Rezzani, 2014).
During pilot studies to determine the safety and potential benefits of
MFSO on improving the attributes of hair and alleviating skin conditions
involving the hands, a number of subjects anecdotally described their
hands and fingers feeling more nimble (Del Campo et al., forthcoming).
Elastomer gels and sheets have a wide range of cosmetic topical
targeted delivery applications. For example, they have proven effective
in the prevention of hypertrophic scars when applied as an adhesive
under occlusion on skin (Foo & TristaniFirouzi, 2011). When bioactive
substances, such as vitamin E, are incorporated into the gels, their effi-
cacy is enhanced possibly due to the occlusion that occurs with the
application of modest pressures through compression that has been
shown to provide a simple noninvasive method to enhance the skin
permeability of substances (Palmieri, Gozzi, & Palmieri, 1995; Zhai &
Maibach, 2002). Elastomer gels have also been incorporated into wear-
ables, such as sleeves and gloves, for orthopedic use to provide muscu-
loskeletal support. In sports medicine, wearable compression garments
that provide mechanical support have been utilized to improve physical
performance (Kemmler et al., 2009). Studies have documented the ben-
efits of wearing compressive garments for muscle function, recovery
postexercise, motor control, thermoregulation, warming up, and range
of motion (De Glanville & Hamlin, 2012; Hsu et al., forthcoming).
Widely accepted testing methods to evaluate hand and finger func-
tion have been routinely applied in neuropsychology and orthopedic
clinical studies (Amirjani, Ashworth, Olson, Morhart, & Chan, 2011;
Vega, 1969). These bioinstrumentation tests have been previously
reviewed for reliability, accuracy, validity, maintainability, and standard-
ized administration and scoring procedures; and the number of practice
trials needed to control for learning effects have been established
(Robinette, Ervin, & Zehner, 1987). At times, certain modifications have
been implemented to optimize the testing procedures for clinical studies
(Porter, 2003). These bioinstrumentation tests are available for evaluat-
ing different motor skill categories. For example, the Finger TappingTest
(FTT) and Handwriting (HW) Speed Test measure motor speed and the
ability to make repeated movements (Hubel, Reed, Yund, Herron, &
Woods, 2013; Prunty, Barnett, Wilmut, & Plumb, 2013), the Purdue
Pegboard Test (PPT) measures manual dexterity (Ruff & Parker, 1993),
and the Hand Steadiness Tracing Pattern Test (HSTPT) measures the
speed and ability to keep the hand steady using fine precision move-
ments while tracing a pattern (Jacobson, WinterRoberts, & Gemmell,
1991). Commercial equipment is routinely used to accurately measure
grip and finger pinch strength with fatigue (Bohannon, 2003).
The objective of this preliminary clinical study was to assess the
safety and efficacy of MFSO combined with compression on its ability
to measurably improve the physical performance skills of the hands
and fingers of healthy righthanded subjects. To achieve this objective,
a novel wearable compression wristband was developed that would
contain the MFSO within a flexible elastomeric gel. When worn with
firm compression, the wristband would effectively and continuously
deliver the MFSO directly to the target area.
2|MATERIALS AND METHODS
2.1 |Participants
Main criteria for inclusion were (a) age range 2166 years; (b) healthy
volunteers; (c) written informed consent; (d) confirmed as righthanded
by responses to the Edinburg Handedness Inventory survey form; (e)
right hand performing significantly better than the left hand on more
than half of the tests, as assessed with the motor skills tests used for
this study [percent (%) difference calculation]; and (f) willing to not sig-
nificantly change their normal daily physical routines during the study.
Among the exclusion criteria were (a) any musculoskeletal upper
extremity symptom or condition in the past year; (b) use of any medi-
cine or treatment that may significantly affect the study outcome in
the past 3 months; (c) a history of any medical or surgical event or
condition that may significantly affect the study outcome, including
cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal
disorders; (d) use of any new upper extremity training methods during
the study; (e) use of any new drugs or performance enhancing products
during the study; (f) use of caffeine, tea, energy drinks, or supplements
during the 48 hr before each study visit; (g) use of any other upper
extremity wearable product during the study; and (h) participation in
another clinical trial or the use of an investigational product in the past
60 days. All clinical study procedures were approved by the Aspire
Institutional Review Board (reference number PRO007) for the protec-
tion of human subjects. Before any study procedures were performed,
the experimental procedures and risks/benefits were discussed with
the subjects, and written informed consent was obtained.
2.2 |Study design and testing protocol
The preliminary study was conducted as a doubleblind, placebocon-
trolled clinical trial. Participants were evaluated by staff on four visits
during the study; at an initial screening visit (Visit 1), at baseline/pre-
treatment (Visit 2), after 46 weeks of treatment (Visit 3), and after
610 weeks of treatment at the end of the study (Visit 4). At Visit 1,
subjects that met the entrance criteria were enrolled into the study.
At visit 2, subjects that continued to meet the entrance criteria were
randomized and subsequently treated. One group of subjects received
the wristband containing MFSO, the second group, an identical
wristband without MFSO (vehicle only).
Study participants and staff were blinded with regard to which
participants were in Groups 1(n= 23) and 2 (n= 15). The subjects were
instructed to (a) wear their wristband snugly on the wrist for at least
3 hr every day, not to exceed 8 hr a day, for the duration of the study;
(b) immediately report the occurrence of any adverse event to the staff
and temporarily discontinue the use of the wristband until reevaluated;
(c) complete a diary log form to document compliance with the daily
2GORIN ET AL.
use of the study wristband product and to report all adverse events; (d)
not use the wristband when bathing or sleeping; (e) properly clean and
store the wristband when not in use; and (f) wear the wristband on one
designated hand; only on the left hand for the initial 46 weeks of
treatment. At Visit 3, participants were evaluated and told to discon-
tinue the use of the wristband on their left hand and wear the
wristband only on the right hand until their next visit. At Visit 4, partic-
ipants were evaluated, and the wristband and diary log form were col-
lected. During Visits 3 and 4 (the two treatment visits), (a) participant
diary log forms were reviewed to document compliance with the use
of the study product, the reporting of any adverse events, and other
comments; (b) safety evaluations were conducted, and the subjects
asked to report any adverse events; (c) any change in the use of the
concomitant medications related to the treatment conditions were
documented; and (d) wristbands were inspected for signs of use.
During all study visits, the participants had their hands subjected to a
battery of bioinstrumentation tests to evaluate their hand and finger
motor skills.
2.3 |Investigational product
The Synsepalum dulcificum seeds were secured from local growers in
Africa, and the MFSO was extracted using supercritical CO
2
fluid
extraction methods in the USA (Pérez, Ruiz del Castillo, Gil, Blanch, &
Flores, 2015). The yield of the crude oil extract was 8% (based on
dry weight). The HPLC fingerprint of the total methanolic extract of
the MFSO sample is shown in Figure 1. To improve the delivery of
the MFSO, such that the MFSO could be released upon contact with
the underlying skin progressively over time, the MFSO was incorpo-
rated within a flexible styreneethylene/butylenestyrene copolymer
thermoplastic elastomeric gel. To confirm the proper amount of
delivery over time, the exudation of the oil from the elastomer gelati-
nous composition to a surface was determined (Matteliano, Schaffer,
& Sutton, 2010). These tests revealed that the gel was capable of
releasing and properly delivering the oil for a period of months
[unpublished observations]. To form the wristband and achieve
targeted delivery of the MFSO, the elastomeric gel was heat bonded
to an overlying stretchable fabric with one end attached to a Velcro
strap. The wristbands containing MFSO (or vehicle control with no
MFSO) were manufactured for the Miracle Fruit Oil Company (Miami
Beach, FL, USA).The wristbands were the same size, and when worn
to comfortably support the wrist without blocking movement, the
average pressure generated was 29 mm ± 5 mm hg as per the
manufacturer's instructions for comfortable fit. The wristband samples
were received at the study site under code in blinded form and stored
at ambient humidity and temperature.
2.4 |Assessment of hand and finger motor skills
A battery of six characteristic and reliable quantitative hand and finger
bioinstrumentation tests used routinely in research studies and clini-
cal practice were utilized to assess the effects of a MFSO wristband
on the subject's motor skills performance (Table 1). Certain modifica-
tions from the accepted test methods were performed to assess new
parameters or to optimize the measurement of the variables of inter-
est. The tests quantitatively measured 12 hand and finger variables,
which included finger tapping speed, endurance until fatigue, explosive
power or quickness, and acceleration; accuracy and manual dexterity
with fine and gross motor skills, hand steadiness and precision with
errors, handwriting speed and mobility, and grip/pinch strength with
fatigue. For each participantvisithand combination (e.g., Subject 1,
Visit 2, left hand), each test was conducted twice in a testretest for-
mat (i.e., replicate measurements). Specific clinical procedures were
implemented for the performance of the bioinstrumentation tests in
an attempt to reduce procedural and interviewer test bias (Table 2).
On each visit, all subjects' hand and finger motor skill perfor-
mances were assessed with the same battery of bioinstrumentation
tests. For all tests, the percent difference between right and left hand
performance (mean and max values) was calculated and used to deter-
mine if the subject met the relevant entrance criterion.
FTT with fatigue (FTTF): The FTT was used to measure finger tapping
movements and was performed using a digital FTT App designed by
Sybu Data (Pty) LTD (Cape Town, South Africa; www.sybu.co.za). The
FTT was modified to include an extended 120s duration (normally at
10 s) to allow for the measurement of finger fatigue. The speed of finger
tapping was measured for the right and left index finger separately as
described (Vega, 1969). The results were expressed as the number of
taps for each individual run including the maximal and mean values
among the replicate tests for each hand. It was arbitrarily decided to
select and compare a 20s time interval near the beginning (at the 10
to 30s interval) and end of the test (at the 90to 110sinterval)for
the measurements of finger fatigue. The percentage of FTTF value for
each run was calculated as the difference between the FTT number of
taps among the two intervals divided by the FTT number of taps during
the first interval × 100. TheFTT explosive power (FTTEP) and FTT accel-
eration (FTTA) were defined as the number of taps during the first sec-
ond and the time (seconds) needed to reach 60 taps, respectively.
PPT: Fine finger dexterity and gross hand movements were mea-
sured using the PPT as described by the manufacturer (Lafayette
Instrument Company, Lafayette, IN, 47904, USA). The PPT was
FIGURE 1 HPLC fingerprint of the total methanolic extract of the
MFSO sample. A 100 mg/ml total methanolic extract of MFSO
sample was analyzed using HPLC with detection wavelength at
228 nm. A combination of water and methanol with 0.1% acetic acid
were used as mobile phases with the gradient of increasing methanol
ratio over time.
GORIN ET AL.3
modified such that the new endpoint was the time (seconds) needed to
complete the placement of all 50 pins into the pegboard and placed
back into the cups of origin.
HSTPT: Hand steadiness using the HSTPT to measure fine preci-
sion movements was performed as previously described (Robinette
et al., 1987). The test was scored by the duration of time (seconds) it
took the subject to complete all the segments in the pattern. If the
participant raised the pen, moved the paper (more than ½ inch in any
direction at any given time), crossed a line within a segment, or if the
crossed line spanned additional adjacent segments, it was counted as
an error. Subjects were allowed up to 5 errors with the right hand
and 20 errors with the left for the test to be counted.
HW Speed test: Gross and fine singlehanded motor skills were
measured using the HW Speed test as previously described (Prunty
et al., 2013). The subject was instructed to write their first name on
standard lined paper as many times as possible in 60 s. The test was
scored based upon the total number of letters written.
GS and GSF: Maximal isometric and sustained grip force with
fatigue were measured using a handheld dynamometer as per the
manufacturer's instructions (Vernier Software and Technology, Bea-
verton, OR, 97005, USA). For the maximal GS value, the subject
applied maximal GS pressure for 10 s. The percentage of difference
in the maximal gripping force (and mean force) GS differentials
between the subjects' right and left hands were calculated in newtons
(N). For the sustained GS, the subject applied maximal pressure for
100 s. The percentage of GSF maximal value for each run was calcu-
lated as the difference between the GS max among the two intervals
(during the 0to 10s and 90to 100s intervals) divided by the GS
max during the first interval × 100.
PS and PSF: Maximal isometric and sustained pinch forces with
fatigue were measured using the same equipment as for GS. For
the maximal and sustained PS values, the participant applied maxi-
mal PS pressure for 10 and 60 s, respectively. The second maximum
PSmeasurementwastakenatthe50to 60sinterval.Thedata
entry and calculations for PS and PSF were the same as with the
GS and GSF.
2.5 |Questionnaires
Participants completed a selfassessment hand and finger perfor-
mance outcome questionnaire at every visit. Participants rated the
performance of their hands and fingers with regard to movements,
strength, and sensation with the use of each hand using a 1 (most pos-
itive)to5(most negative) rating scale. At Visits 3 and 4, participants
were also asked to document if a perceptual benefit in mobility,
strength, or sensation occurred, compared with Visits 1 and 2 and if
TABLE 1 Motor skills assessments
Test Assessment
Finger Tapping Speed: Number of taps in 120 s. Fatigue: Number of taps at 1030 s versus at 90110 s
Explosive power: Number of taps in 1st second. Acceleration: Time from 060 taps
Purdue Pegboard Time to place and remove pins on a pegboard
Hand Steadiness Tracing Pattern Time to trace complex segmented pattern. Number of errors
Handwriting Number of letters written in 60 s
Grip Strength & Fatigue Strength: Max force at 010 s. Fatigue: Max force at 010 s versus at 90100 s
Pinch Strength & Fatigue Strength: Max force at 010 s. Fatigue: Max force at 010 s versus at 5060 s
TABLE 2 Clinical procedures for motor skills assessments
(a) All testing was performed in a quiet, isolated, and enclosed room to reduce the effects of outside visual and auditory interference.
(b) Subjects were evaluated in the same room with the same lighting, same chair and desk, and instructed to maintain the same posture for the
performance of each test to reduce the effects of the room environment.
(c) Subjects were tested at the same time period on every visit (either morning or afternoon) to reduce the effects due to the time of day.
(d) Subjects were only allowed to wear the wristband (no jewelry, watches, or other garments worn on their upper extremities), and mobile phones were
shut off during the performance of the tests.
(e) An investigatorgenerated randomization procedure was used to reduce the effect of the test order.
(f) Subjects were assigned to and evaluated by the same staff investigator during all of their visits.
(g) Standardized written instructions were given to each participant for them to read to familiarize themselves with the testing procedures.
(h) The investigator provided the same verbal instructions in the same tone of voice during each test to reduce the effects due to coaching.
(i) Subjects were instructed to alternate their sequence of which hand to use first among each different test to reduce the effect of hand order.
(j) Subjects performed each test alternating each hand in duplicate studies (total of four independent runs for each test during each visit).
(k) Subjects were provided with two practice runs for each test (one run with the use of each hand) at the screening visit to become familiarized with the
performance of each test.
(l) Subjects were instructed to have a warmup practice period (35 min) prior to the official performance of their first test of the baseline and
posttreatment visits to reduce a lack of preparedness.
(m) Subjects had to complete each individual test without a break (four independent runs) but were allowed up to a 5min break to reduce fatigue before
proceeding to a different test.
(n) Test results were recorded by staff members in the subject case report forms immediately after each test was completed.
(o) Subjects performed and completed all tests in 1 day during each study visit.
4GORIN ET AL.
so, to describe the benefit in detail. They were also asked if they
noticed improvements in accomplishing certain tasks with the use of
both hands. At Visit 4, participants answered a product use assess-
ment questionnaire providing their degree of satisfaction with the
wristband product. They were also asked to reveal any perceptual
improvements in mobility, skills, strength, and endurance as well as
in their performance of 22 commonly routine specific tasks such as
typing, texting, and writing.
2.6 |Statistical analysis
The sample size for this preliminary study was selected to sufficiently
characterize the performance of the MFSO treatment group and to
provide adequate power to assess the amount of the MFSO group
performance that is above and beyond that observed in the gel band
control group. Sample sizes of at least 20 subjects in the MFSO group
and at least 15 subjects in the control group were deemed to meet
these criteria, according to the power analysis. For example, relative
to the improvement in the number of finger taps (Finger Tapping Test),
using a twosided independent sample ttests, a sample size of 20 in
the MFSO group and 15 in the control group provided at least 90%
power to detect a difference of 30 taps between treatment groups,
assuming a common standard deviation of 25 taps and 0.05 level of
significance.
For each hand test variable, the primary analysis was improvement
from baseline (defined as Visits 3 and 2 for left hand and Visits 4 and 3
for right hand). A secondary analysis examined the change from base-
line at Visit 4 for the left hand. The arithmetic mean of the two repli-
cate measurements was used for the analysis. The two treatment
groups were compared at baseline to assess homogeneity and at end-
point using a oneway analysis of variance (ANOVA) at the 0.05 level
of significance. Questionnaire data were summarized by treatment
group by presenting the number and percentage of subjects included
in a given category. No statistical testing was performed on the ques-
tionnaire data. Bioinstrumentation study data were analyzed using
SAS® Software Version 9.2.
3|RESULTS
Fortysix healthy righthanded subjects were randomized and received
treatment. Eight subjects voluntarily withdrew due to personal rea-
sons unrelated to the treatment and did not complete the study,
resulting in a total of 38 participants completing the study (MFSO,
n= 23; Vehicle, n= 15). Subject ages ranged from 21 to 66 years with
a mean (SD) of 42.8 (12.98) years. Most subjects were male (73.7%)
and most had a college or postgraduate degree (57.9%). Selfreported
adherence to the study wristband among all subjects was equally high
across the two treatment groups (>90% diarylogged days of use). No
subject reported any adverse reaction with the use of any of the
wristbands.
Using a significance level of 0.05, none of the statistical tests
for left hand assessments at baseline resulted in statistically
significant differences between the two treatment groups. Three
tests [PPT, HSTPT (errors), and GSF] for the right hand showed
some departure from homogeneity at baseline, but in none of these
cases was this departure considered clinically remarkable. Therefore,
the assumption of homogeneity at baseline was reasonable, and the
change from baseline for each variable was a meaningful endpoint
or reference.
3.1 |Effect of MFSO on hand and finger motor skills
Mean improvements in the hand and finger motor skills parameters
were evident with the use of the MFSO band during both treatment
intervals; after 46 (Visit 3) and 24 weeks (Visit 4) of use on the left
and right hand, respectively (Figures 2 and 3). With each hand, in 9
of 12 bioinstrumentation tests, the MFSO group showed a clinically
meaningful average improvement compared with an average worsen-
ing in the vehicle group (Tables 3 and 4). The average MFSO group
improvement and difference between treatment group means of the
left/right hands were FTT 46.9 taps, 56.8 taps (p< .0001)/47.7 taps,
57.8 taps (p < .0001); FTTEP 1.0 tap, 1.6 taps (p < .0001)/0.8 tap,
1.0 taps (p= .0004); FTTA 1.9 s, 2.4 s (p < .0001)/1.1 s, 1.5 s
(p < .0001); FTTF 12.1%, 12.7% (p= .0007)/6.9%, 8.7% (p ˂.0001);
PPT 16 s, 19.0 s (p < .0001)/11.6 s, 14.0 s (p < .0001); HSTPT 16.7 s,
20.1 s (p < .0001)/13.1 s, 17.0 s (p < .0001); HW Speed test 16.9 let-
ters, 17.0 letters (p < .0001)/35.9 letters, 32.2 letters (p < .0001); GS
37.7 N, 39.6 N (p = .0004)/24.7 N, 27.7 N (p= .0096); and PS 8.0 N,
15.2 N (p < .0001)/10.0 N, 14.2 N (p= .001). No differences were
found in the HSTPT errors, GSF, and PSF tests. The placebo control
treatment group did not perform statistically better than the MFSO
band treatment group in any of the 12 hand and finger tests.
The hand outcomes and wristband use questionnaires analyses
indicated that the use of the MFSO wristband was associated with a
greater level of favorable responses when compared with the control
group. At Visit 3, more than 50% of the subjects in the MFSO band
treatment group reported an improvement in left hand strength and
in accomplishing daily tasks compared with less than 22% in the con-
trol group. At Visit 4, a similar response occurred with the right hand
outcomes. For each of the four categories (i.e., movement, skill,
strength, and endurance), at least 39% of the subjects in the MFSO
band treatment group reported an improvement using the wristband
compared with less than 14% in the control group. In all but one of
the 18 improvement categories, the percentage of subjects reporting
improvement in the MFSO band treatment group was more than twice
that of the control treatment group.
3.2 |Effect during no treatment on hand and finger
motor skills
After 46 weeks of no treatment with the righthand (Visit 3), there
were no clinically meaningful changes (from Visits 2 to 3) for any of
the 12 right hand tests (data not shown). After 24 weeks of no
treatment with the left hand (Visit 4), there was a noticeable return
toward baseline (Visit 2) levels in all nine left hand tests that had
previously shown an improvement (Figure 4). The decline was not
extreme, and for the FTT, FTTF, PPT, HSTPT (seconds), and HW speed
test, a modest portion of the effect observed at Visit 3 was preserved
at Visit 4.
GORIN ET AL.5
FIGURE 2 Left hand assessments by
treatment group. Improvement (mean ± SD)
from Visit 2 (baseline) at Visit 3 by treatment
group in left hand (a) finger tapping tests, (b)
dexterity (PPT), steadiness (HSTPT), and speed
(HW speed test), and (c) grip/pinch strength
and fatigue. For each test, the MFSO band
treatment group was compared with the
control group using a oneway ANOVA.
MFSO = miracle fruit seed oil; PPT = Purdue
Pegboard Test; HSTPT = Hand Steadiness
Tracing Pattern Test; HW = handwriting;
GS = grip strength; PS = pinch strength;
GSF = grip strength fatigue; PSF = pinch
strength fatigue [Colour figure can be viewed
at wileyonlinelibrary.com]
6GORIN ET AL.
FIGURE 3 Right hand assessments by
treatment group. Improvement (mean ± SD)
from Visit 3 (baseline) at Visit 4 by treatment
group in right hand (a) finger tapping tests, (b)
dexterity (PPT), steadiness (HSTPT), and speed
(HW speed test), and (c) grip/pinch strength
and fatigue. For each test, the MFSO band
treatment group was compared with the
control group using a oneway ANOVA.
MFSO = miracle fruit seed oil; PPT = Purdue
Pegboard Test; HSTPT = Hand Steadiness
Tracing Pattern Test; HW = handwriting;
GS = grip strength; PS = pinch strength;
GSF = grip strength fatigue; PSF = pinch
strength fatigue [Colour figure can be viewed
at wileyonlinelibrary.com]
GORIN ET AL.7
4|DISCUSSION
This study is the first clinical trial to demonstrate the safety and effi-
cacy of the use of a fruit seed oil incorporated into a wearable com-
pression garment for improving the performance of hand and finger
motor skills. This was also the first placebocontrolled, doubleblind,
clinical study that compared the efficacy of this unique type of combi-
nation product with its vehicle. The results of this preliminary clinical
study demonstrated a meaningful within MFSO band treatment group
improvement in 9 of 12 bioinstrumentation motor skills tests with the
use of either hand in righthanded subjects. In addition, the subjects in
the MFSO band treatment group robustly demonstrated statistically
significant and clinically meaningful improvement compared with the
placebo control group with respect to finger tapping measurements,
hand dexterity metrics, and strength assessments. The differences
between treatment means were quite substantial that would represent
a marked performance benefit when using the MFSO band compared
with the control treatment. Furthermore, the selfassessments also
demonstrated that subjects favored the MFSO band over the control
band on all tested attributes.
In all control participants, there were (a) no instances where the
control group was statistically superior to the MFSO band with regard
to improvement; (b) numerous instances where the control group led
to a decline in performance skills or an insignificant improvement;
and (c) numerous instances where the improvement in the MFSO band
was statistically superior to the improvement seen with the control
group. These findings suggest that compression is not sufficient to pro-
vide the beneficial results that were observed. A limitation of the study
design was that it did not address the use of the MFSO alone without
the compression wristband. It is possible that MFSO or other vegeta-
ble oils could exert a beneficial effect on hand performance after their
direct application on the wrist independent of the use of compression.
However, the messy and greasy application of oils and the need for
repeated applications would be expected to reduce compliance. In
TABLE 3 Left hand assessments
Variable Endpoint
MFSO band
(n = 23)
Vehicle gel band
(n = 15) pvalue
1. Finger Tapping Tests: Speed, explosive power, acceleration, and fatigue
Speed (# of taps) Baseline (Visit 2) mean (SD) 496.7 (66.30) 511.2 (44.36) .4594
Improvement from baseline at Visit 3 mean (SD) 46.9 (22.85) 9.9 (12.34) <.0001
Improvement from baseline at Visit 4 mean (SD) 17.1 (48.97) 18.9 (17.38) NT
Explosive power (# taps in the first second) Baseline (Visit 2) mean (SD) 4.7 (0.79) 5.0 (0.53) .1439
Improvement from baseline at Visit 3 mean (SD) 1.0 (0.73) 0.6 (0.39) <.0001
Improvement from baseline at Visit 4 mean (SD) 0.5 (0.80) 0.4 (0.44) NT
Acceleration [time to 60 taps (seconds)] Baseline (visit 2) mean (SD) 13.1 (2.37) 12.3 (0.99) .2613
Improvement from baseline at Visit 3 mean (SD) 1.9 (1.26) 0.5 (0.38) <.0001
Improvement from baseline at Visit 4 mean (SD) 0.6 (1.86) 0.7 (0.73) NT
Fatigue (%) Baseline (visit 2) mean (SD) 13.5 (6.54) 13.0 (12.64) .8788
Improvement from baseline at Visit 3 mean (SD) 12.1 (6.39) 0.6 (14.41) .0007
Improvement from baseline at Visit 4 mean (SD) 4.3 (7.93) 2.3 (13.41) NT
2. Dexterity, steadiness, and speed
Purdue Pegboard Test (seconds) Baseline (Visit 2) mean (SD) 174.1 (14.98) 180.9 (24.97) .2997
Improvement from baseline at Visit 3 mean (SD) 16.0 (11.59) 3.0 (11.69) <.0001
Improvement from baseline at Visit 4 mean (SD) 5.8 (12.28) 2.2 (5.87) NT
Hand Steadiness Tracing Pattern Test (seconds) Baseline (Visit 2) mean (SD) 85.4 (21.86) 78.9 (19.70) .3549
Improvement from baseline at Visit 3 mean (SD) 16.7 (16.40) 3.4 (6.50) <.0001
Improvement from baseline at Visit 4 mean (SD) 5.7 (15.41) 4.9 (6.39) NT
Hand Steadiness Tracing Pattern Test (# of errors) Baseline (Visit 2) mean (SD) 4.5 (2.88) 6.5 (3.95) .0793
Improvement from baseline at Visit 3 mean (SD) 0.0 (2.27) 0.4 (2.24) .5279
Improvement from baseline at Visit 4 mean (SD) 0.7 (2.63) 2.0 (3.46) NT
Handwriting Speed Test (# of letters) Baseline (Visit 2) mean (SD) 70.0 (20.80) 64.9 (30.95) .5473
Improvement from baseline at Visit 3 mean (SD) 16.9 (9.87) 0.1 (12.06) <.0001
Improvement from baseline at Visit 4 mean (SD) 11.3 (17.29) 3.7 (13.15) NT
3. Grip/pinch strength and fatigue
Grip strength maximum force (N) Baseline (Visit 2) mean (SD) 212.8 (85.99) 196.7 (72.60) .5544
Improvement from baseline at Visit 3 mean (SD) 37.7 (21.79) 1.9 (40.13) .0004
Improvement from baseline at Visit 4 mean (SD) 5.4 (41.17) 5.5 (49.01) NT
Grip strength fatigue (%) Baseline (Visit 2) mean (SD) 64.0 (8.52) 66.0 (5.61) .4224
Improvement from baseline at Visit 3 mean (SD) 4.9 (9.84) 0.2 (10.65) .1768
Improvement from baseline at Visit 4 mean (SD) 0.5 (8.94) 0.7 (8.37) NT
Pinch strength maximum force (N) Baseline (Visit 2) mean (SD) 68.7 (20.56) 70.3 (20.01) .8147
Improvement from baseline at Visit 3 mean (SD) 8.0 (10.36) 7.2 (10.45) <.0001
Improvement from baseline at Visit 4 mean (SD) 2.1 (20.35) 10.1 (16.53) NT
Pinch strength fatigue (%) Baseline (visit 2) mean (SD) 59.4 (7.35) 57.6 (14.42) .6039
Improvement from baseline at Visit 3 mean (SD) 0.2 (9.53) 0.2 (14.65) .9970
Improvement from baseline at Visit 4 mean (SD) 0.3 (10.52) 3.9 (16.98) NT
Note.pvalue is from a oneway ANOVA Ftest. MFSO = miracle fruit seed oil; SD = standard deviation; NT = not tested; N = newtons.
8GORIN ET AL.
addition, if the full benefit in improvement of performance can only be
realized with the use of the oil combined with a durable garment that
provides compression, the wristband provides an efficient and practi-
cal choice for enhanced subject compliance.
This study design approach provided added benefits because it
allowed for a comparison with the contralateral hand serving as an
additional no band treatment control and an evaluation of efficacy at
two different treatment time intervals. During the use of the MFSO
band exclusively on the left hand for 46 weeks, the subject's
untreated right hand values remained near baseline and showed no
clinically meaningful improvements in performance skills. The switch
of the MFSO band to its exclusive use on the right hand for 24 weeks
resulted in an improvement of the right hand performance skills and a
concomitant reduction in the performance skills of the left hand. The
left hand manifested a major decline returning in the direction toward
nearbaseline levels of performance in nearly all of the tests, reversing
most of the gains in the improvements previously obtained with the
use of the MFSO wristband. These results indicate that for the favor-
able benefits to continue and persist over time, the MFSO wristband
should be routinely worn and not discontinued. This finding also adds
further support to the original hypothesis that the beneficial results
in hand and finger performance skills that were observed are associ-
ated with the exclusive wear of the MFSO wristband. The degree of
improvement in physical performance skills was fairly similar when
wearing the MFSO band on the left or right hand, indicating that the
beneficial effects on performance occurred as early as after 24 weeks
of treatment.
Apart from this randomized study, 10 additional subjects who did
not participate in the study, but had similar entry criteria, agreed to be
simultaneously followed and assessed with the use of the commer-
cially available Power Balance® band (n= 4; Verdan et al., 2012) and
on no treatment (n= 6) according to the study timelines. This explor-
atory analysis was conducted to observe (a) the effects of a popular
commercial brand of performance wristband and (b) the typical vari-
ability in hand/finger motor skills over time in subjects with no band.
In the four subjects that wore the Power Balance® band, there was
a tendency toward a negative mean improvement from baseline values
in the majority of the tests that were performed for both hands, possi-
bly indicating that hand performance skills may worsen with the use of
certain bands. In the six subjects that received no treatment, the
changes in the motor skills tests were unremarkable.
Although the exact mechanism of action for the enhanced
performance effects observed with the MFSO band remains unknown,
it can be speculated that the MFSO band improves the stability,
mobility, and flexibility of the wrist joint. The combination of sustained
and prolonged firm mechanical compression, the occlusion formed
upon contact of the gel with skin, the lubricity imparted by the oil,
and the ingredients in the MFSO may play a role. Prolonged compres-
sion and occlusion of the skin with a highly lubricated oilbased
elastomeric gel may produce slight increases in the local temperature
TABLE 4 Right hand assessments
Variable Endpoint
MFSO band
(n = 23)
Vehicle gel band
(n = 15)
p
value
1. Finger tapping tests: Speed, explosive power, acceleration, and fatigue
Speed (# of taps) Baseline (Visit 3) mean (SD) 559.8 (58.36) 563.0 (53.00) .8634
Improvement from baseline at Visit 4 mean (SD) 47.7 (39.25) 10.1 (13.10) <.0001
Explosive power (# taps in the first second) Baseline (Visit 3) mean (SD) 5.2 (0.84) 5.1 (0.74) .6934
Improvement from baseline at Visit 4 mean (SD) 0.8 (0.89) 0.2 (0.62) .0004
Acceleration [time to 60 taps (seconds)] Baseline (Visit 3) mean (SD) 11.7 (1.42) 11.9 (1.29) .5797
Improvement from baseline at Visit 4 mean (SD) 1.1 (0.81) 0.4 (0.66) <.0001
Fatigue (%) Baseline (Visit 3) mean (SD) 8.5 (3.08) 8.1 (3.65) .7165
Improvement from baseline at visit 4 mean (SD) 6.9 (4.01) 1.8 (4.42) <.0001
2. Dexterity, steadiness, and speed
Purdue Pegboard Test (seconds) Baseline (Visit 3) mean (SD) 152.3 (9.86) 165.3 (20.16) .0120
Improvement from baseline at Visit 4 mean (SD) 11.6 (9.01) 2.4 (9.32) <.0001
Hand Steadiness Tracing Pattern Test (seconds) Baseline (Visit 3) mean (SD) 63.5 (17.39) 63.2 (18.89) .9617
Improvement from baseline at Visit 4 mean (SD) 13.1 (10.32) 3.9 (7.92) <.0001
Hand Steadiness Tracing Pattern Test (# of errors) Baseline (Visit 3) mean (SD) 2.1 (1.64) 3.8 (2.23) .0117
Improvement from baseline at Visit 4 mean (SD) 0.4 (2.12) 0.6 (2.70) .8017
Handwriting Speed Test (# of letters) Baseline (Visit 3) mean (SD) 162.9 (27.31) 152.2 (39.35) .3252
Improvement from baseline at Visit 4 mean (SD) 35.9 (26.70) 3.7 (8.61) <.0001
3. Grip/pinch strength and fatigue
Grip strength maximum force (N) Baseline (Visit 3) mean (SD) 238.3 (87.37) 210.1 (70.85) .3031
Improvement from baseline at Visit 4 mean (SD) 24.7 (34.04) 3.0 (23.86) .0096
Grip strength fatigue (%) Baseline (Visit 3) mean (SD) 62.8 (9.33) 69.0 (6.66) .0325
Improvement from baseline at Visit 4 mean (SD) 3.0 (7.66) 1.2 (11.26) .1791
Pinch strength maximum force (N) Baseline (Visit 3) mean (SD) 72.5 (21.00) 76.3 (23.30) .6036
Improvement from baseline at Visit 4 mean (SD) 10.0 (12.38) 4.2 (11.01) .001
Pinch strength fatigue (%) Baseline (Visit 3) mean (SD) 54.8 (11.20) 59.3 (10.89) .2274
Improvement from baseline at Visit 4 mean (SD) 1.3 (12.86) 1.5 (13.33) .5236
Note.pvalue is from a oneway ANOVA Ftest. MFSO = miracle fruit seed oil; SD = standard deviation; N = newtons.
GORIN ET AL.9
FIGURE 4 Left hand assessments: MFSO
group with and without band. Improvement
(mean ± SD) from Visit 2 (baseline) at Visit 3
(with band) and at Visit 4 (without band) for
the MFSO band treatment group in left hand
(a) finger tapping tests, (b) dexterity (PPT),
steadiness (HSTPT), and speed (HW speed
test), and (c) grip/pinch strength and fatigue.
MFSO = miracle fruit seed oil; PPT = Purdue
Pegboard Test; HSTPT = Hand Steadiness
Tracing Pattern Test; HW = handwriting;
GS = grip strength; PS = pinch strength;
GSF = grip strength fatigue; PSF = pinch
strength fatigue [Colour figure can be viewed
at wileyonlinelibrary.com]
10 GORIN ET AL.
and regional circulation that could affect the functional mobility of the
underlying tissues.
Apart from or in combination with the mechanical and physical
effects, the phytochemicals and nutrients in the MFSO may have an
important physiological role in the observed effect (Guney & Nawar,
1977; Inglett & Chen, 2011). Sufficient evidence exists in Ayurveda
and traditional Chinese medicine for the support of the effectiveness
of the topical application of herbal preps and bioactive oils, alone or
in combination with physical modalities, acting as antioxidants and
antiinflammatory agents for the management of musculoskeletal
conditions, such as back pain, joint stiffness, and arthritis (Cibere
et al., 2003; Shoara et al., 2015; Yip & Tse, 2004). Although the
composition of the MFSO is complex and relatively unexplored, it
contains abundant amounts of phytochemical compounds such as
the polyphenols, triterpenes, and phytosterols that exhibit antioxi-
dant, antiinflammatory, and regenerative activities (Del Campo et al.,
forthcoming; Wu et al., 2013; Thirupathi et al., 2017; Loizou et al.,
2010; Lee et al., 2014). Polyphenols, such as the anthocyanins and
flavonoids, appear to be beneficial for improving physical perfor-
mance during exercise (Cases et al., 2017; Davis et al., 2010;
Yarahmadi et al., 2014). In addition to acting as antioxidants in the
prevention of exercise induced muscle damage, polyphenols affect
endothelial cell nitric oxide synthetase leading to vasorelaxation and
increases in blood flow to musculoskeletal tissues, thereby improving
locomotion (Goldfarb, 1999; Lorenz et al., 2004). Musculoskeletal
locomotor function and homeostasis may also be affected by the
essential nutrients contained within the MFSO, such as vitamin K,
linoleic acid, and elemental silicon (Rodella et al., 2014). For example,
vitamin K deficiency (Cocchetto et al., 1985) has been reported to
reduce locomotor activity whereas a high dietary intake of linoleic
acid (Raygada et al., 1998) increased the activity, reducing the time
spent immobile. Furthermore, in clinical studies, vitamin K and silicon
supplementation were shown to improve bone health favoring regen-
eration while reducing resorption (Craciun, Wolf, Knapen, Brouns, &
Vermeer, 1998; Spector et al., 2008). Nevertheless, the identification
of the compound(s) contributing to the effect on the performance
parameters and the mechanism of action need to be investigated
and require further study.
The use of the MFSO band may also provide significant benefits to
persons wanting an improvement when performing manual tasks to
enhance productivity during activities of daily living. For example, a
participant noted that while wearing the MFSO wristband, he was able
to use his left hand much better to text on his phone and perform more
pushups. Also, several subjects reported that their videogaming skills
improved and were able to win more games due to faster hand and fin-
ger movements when handling the controller. Despite these favorable
accounts, the full benefits in performance may not be realized if
persons do not continue the use of the product for long enough. To
maximize compliance with the use of the wristband, education will
be needed to motivate users by encouraging confidence in its safety
and benefits as well as providing reassurance with appropriate expec-
tations. Innovative strategies focusing on the targeted topical delivery
of phytochemicals and nutrients as ergogenic aids for improving
functional performance and enhancing productivity represents an
important avenue for future investigations.
5|CONCLUSIONS
Righthanded subjects that used the MFSO band demonstrated clini-
cally meaningful improvements when compared with the vehicle band
control group with respect to finger tapping measurements, hand dex-
terity metrics, and strength assessments. When worn, a wristband con-
taining MFSO can act as an ergogenic aid to improve an individual's
hand and finger motor skills and ability to maintain this performance.
ACKNOWLEDGEMENTS
This study was supported by a research grant from the Miracle Fruit
Oil Company. The authors wish to acknowledge André E Roodt, Sybu
Data, sybu.co.za, for developing the FTT App used in this study.
CONFLICT OF INTEREST
S. G., G. Z., E. S., C. J. M., and A. E. F. have no conflict of interest. C. W.
received consulting support from the Miracle Fruit Oil Company.
ORCID
Steven Gorin http://orcid.org/0000-0003-4546-7897
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How to cite this article: Gorin S, Wakeford C, Zhang G,
Sukamtoh E, Matteliano CJ, Finch AE. Beneficial effects of an
investigational wristband containing Synsepalum dulcificum
(miracle fruit) seed oil on the performance of hand and finger
motor skills in healthy subjects: A randomized controlled pre-
liminary study. Phytotherapy Research. 2017;112. https://doi.
org/10.1002/ptr.5980
12 GORIN ET AL.
... In the food and beverage industry, the fruit is used as a non-nutritive natural sweetener and beverage colourant [8], a reliable substitute to synthetic sugar in lemonade and juice [9] and an ingredient in functional yoghurt preparation [10]. In cosmetics, the seed oil is used to prevent hair breakage [11] and improved finger motor skills [12]. It is also utilized in the prevention and treatment of diabetes and cancer, two non-communicable diseases with heavy socio-economic burdens [13,14]. ...
... In parallel, current exploitation of the species in West Africa mainly relied on just a few stands in farmers' backyards, home gardens and farms [5]. Taken together, these two observations suggest that the current supply is unlikely to meet the growing local and international demands for products of the species (e.g., leaves, roots, seeds and fruits) [12,17,20] and to hold its promise as a lever of West Africa economic growth. Cultivation was suggested as a sustainable alternative to semi-wild or wild harvest of plants when demand outgrows natural populations' capacities [30]. ...
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Despite the growing interest in the miracle plant worldwide due to its numerous applications, the threats and the wild harvest of the species hamper its sustainable utilisation. Moreover, traditional knowledge so far documented on the species is limited to a narrow geographical coverage of its natural distribution range, which is West and Central Africa. This study analysed the use variation and knowledge acquisition pattern of the miracle plant among West African sociolinguistic groups and deciphered the drivers of populations’ willingness and readiness to engage in cultivating the species. Semi-structured interviews were conducted with 510 respondents purposively selected from nine sociolinguistic groups in Benin and Ghana using the snowball sampling approach. Information was collected on respondents’ socio-demographic profile, miracle plant ownership, plant parts used and preparation methods, knowledge of the species bioecology, perceived threats on the species, willingness to cultivate, maximum acreage to allocate to the species and maximum price to pay for a seedling. Descriptive statistics, generalized linear models, classification and regression tree models were used for data analysis. The miracle plant ownership mode depended on the age category. Sociolinguistic affiliation, level of schooling, migratory status and religion significantly affected the number of trees owned. We recorded 76 uses belonging to six use categories. The overall use-value of the miracle plant significantly varied according to the respondent sociolinguistic affiliation, main activity and religion. Men were the main source of knowledge and knowledge is mainly acquired along the family line. Knowledge related to food and social uses was mostly acquired from parents and people of the same generation, while magico-therapeutic and medicinal use-related knowledge were inherited from parents and grandparents. Sociolinguistic affiliation, awareness of taboos and market availability were the most important drivers of respondent willingness to cultivate the miracle plant. While the respondent’s level of schooling and perception of plant growth rate determined the maximum acreage they were willing to allocate to the species in cultivation schemes, their main activity, sociolinguistic affiliation and knowledge of the species time to fruiting drove the maximum purchase price they were willing to offer for a seedling of the species. Our findings provide key information for the promotion of miracle plant cultivation in the study area.
... It also serves as a food additive with its red skin and whitish pulp being, respectively, used for colouring and sweetening beverages and foods 11 . Applications of the species in cosmetics relate to the seed ( Fig. 1e) oil used in hair breakage control and the improvement of hand and finger motor skills 12,13 . In West Africa, particularly in Benin, the miracle fruit is also sold on the open market and thus contributes to improving household livelihoods through income generation 3 . ...
... Due to the increasing interest in S. dulcificum, this study purposively targeted the fruit and its components. For instance, while the edible ratio is of great interest in medicinal, pharmaceutical, food and beverages industries 19 , the seed mass is of interest in pharmaceutical and cosmetics 12,13,75 . Consequently, knowledge of the tree-to tree or population-to population variation for these specific traits would be useful for elite tree selection by the breeders and decision making for investment by stakeholders. ...
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The miracle plant Synsepalum dulcificum is a multipurpose natural sweetener and a promising West African orphan fruit shrub candidate for genetic improvement. Unfortunately, basic knowledge such as phenotypic variation and inheritance estimates required for implementing a breeding program are still lacking. A set of 203 accessions were sampled in two habitats from seven populations spread across the Dahomey Gap (DG) and the Upper Guinea forest (UG) in West Africa. The phenotypic diversity and allometric relationships among functional traits were analysed; the broad-sense heritability was estimated for fruit-traits, and a mini-core collection was developed in the species. Quantitative variation in tree-and fruit-traits was recorded, and multivariate analyses were performed to assess relationships among accessions, whereas heritability was estimated using the coefficient of repeatability. Tree-traits observed in S. dulcificum were more variable than fruit-traits. While habitat-type only affected tree-traits, the provenance population significantly affected both fruit-and tree-traits, with the UG populations outperforming the DG ones. Significant correlations were observed among fruit-traits on one hand, and among tree-traits on the other hand, whereas poor correlations were observed between tree-and fruit-traits. The multivariate analysis grouped accessions in three clusters. Promising individuals for high fruit mass and pulp-dense genotypes' selection were identified within clusters. Repeatability estimates for fruit-traits ranged from 0.015 (edible ratio) to 0.88 (fruit mass). The Core Hunter algorithm enabled the extraction of 41 individuals as robust representatives of the initial set of 203 accessions, and the mapping of this core collection suggested Dahomey Gap as a centre of diversity of the species. These original findings offer opportunities, not only for the genetic improvement of S. dulcificum, but also for targeted ex-situ conservation in the species.
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Background: Hair breakage is a common unrecognized form of hair loss in women most often the result of hair weathering and traumatic grooming practices. Lipids are major determinants of the physical properties of the hair. Synsepalum dulcificum seed oil (MFSO®; Miracle Fruit Oil Co., Miami Beach, Florida), is an exotic fruit oil with physicochemical properties suited to providing a superior ability to reduce hair breakage. Objective: To assess the safety and efficacy of a hair oil containing MFSO and its effects on hair breakage rates. Methods: Healthy, long-haired women (age range: 19-63 years, mean age: 36.7 years, standard deviation: 10.77 years) with excessive hair breakage were randomized in this double-blind, placebo-controlled study to receive MFSO (n=24), vehicle (n=17), or argan oil (n=16). Measurements of hair length, hair diameter, and Hair Mass Index were performed at baseline, Month 4, and Month 8. Hair Breakage Index and the Healthy Hair Index values were calculated from the trichometer measurements, and subject self-assessment questionnaires were conducted. The primary efficacy endpoints were the percent change in Healthy Hair Index 75 and Healthy Hair Index 50 measurements from baseline to the eighth month. Results: The Healthy Hair Index calculations, expressed as percent change from baseline to Month 4 and from baseline to Month 8, revealed that the MFSO® treatment group improved by 103.6 percent and 215.7 percent for the Healthy Hair Index 75 and 133.7 and 188.3 percent for the Healthy Hair Index 50 values, respectively. When compared with the vehicle and the argan oil brand groups, the Healthy Hair Index levels were significantly higher (p < 0.001) for the MFSO® treatment group, indicating a much greater ability to increase the levels of unbroken hairs by reducing hair breakage. With respect to the mean percent improvements from baseline to Month 4 and Month 8, the MFSO® hair oil treatment group was better than each of the other two treatment groups by at least 117.6 percent and 234.9 percent for the Healthy Hair Index 75 and 316.5 percent and 312 percent for the Healthy Hair Index 50 values, respectively, thereby achieving the primary efficacy objective. Subjects favored the MFSO® hair oil treatment, rating it as safe, effective, and aesthetically pleasing. Conclusions: The MFSO hair oil product is a safe and effective option for the treatment of women suffering from hair breakage and damaged hair.
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Workout capacity is energy-production driven. To produce peak metabolic power outputs, the organism predominantly relies more on anaerobic metabolism, but this undoubtedly has a negative and limiting impact on muscle function and performance. The aim of the study was to evaluate if an innovative polyphenol-based food supplement, PerfLoad®, was able to improve metabolic homeostasis and physical performance during high-intensity exercises under anaerobic conditions. The effect of a supplementation has been investigated on fifteen recreationally-active male athletes during a randomized, double-blind and crossover clinical investigation. The Wingate test, an inducer of an unbalanced metabolism associated to oxidative stress, was used to assess maximum anaerobic power during a high-intensity exercise on a cycle ergometer. Supplementation with PerfLoad® correlated with a significant increase in total power output (5%), maximal peak power output (3.7%), and average power developed (5%), without inducing more fatigue or greater heart rate. Instead, oxidative homeostasis was stabilized in supplemented subjects. Such results demonstrated that PerfLoad® is a natural and efficient solution capable of, similarly to training benefits, helping athletes to improve their physical performance, while balancing their metabolism and reducing exercise-induced oxidative stress.
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Background The few previous studies that focused on the effects of compression garments (CG) on distance running performance have simultaneously measured electromyogram, physiological, and perceptual parameters. Therefore, this study investigated the effects of CG on muscle activation and median frequency during and after distance running, as well as blood-lactate concentration and rating of perceived exertion (RPE) during distance running. Methods Eight healthy male recreational runners were recruited to randomly perform two 40 min treadmill running trials, one with CG, and the other with control garment made of normal cloth. The RPE and the surface electromyography (EMG) of 5 lower extremity muscles including gluteus maximus (GM), rectus femoris (RF), semitendinosus (ST), tibialis anterior (TA), and gastrocnemius (GAS) were measured during the running trial. The blood-lactate levels before and after the running trial were measured. Results Wearing CG led to significant lower muscle activation (p < 0.05) in the GM (decreased 7.40%–14.31%), RF (decreased 4.39%–4.76%), and ST (decreased 3.42%–7.20%) muscles; moreover, significant higher median frequency (p <0.05) in the GM (increased 5.57%) and ST (increased 10.58%) muscles. Wearing CG did not alter the RPE values or the blood-lactate levels (p > 0.05). Conclusion Wearing CG was associated with significantly lower muscle activation and higher median frequency in the running-related key muscles during distance running. This finding suggested that wearing CG may improve muscle function, which might enhance running performance and prevent muscle fatigue.
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Grape by-products are a rich source of bioactive compounds having broad medicinal properties, but usually wasted from juice/wine processing industries. The present study investigates the use of Supercritical Fluid Extraction (SFE) to obtain an extract rich in bioactive compounds. First, some variables involved in the extraction were applied. SFE conditions were selected based on the oil mass yield, fatty acid profile and total phenolic composition. As a result, 40 ºC and 300 bar were selected as operational conditions. The phenolic composition of the grape seeds oil was determined using LC-DAD. The antioxidant activity was determined by ABTS and DPPH assays. For the anti-inflammatory activity the inhibition of nitrite production was assessed. The grape seed oil extracted was rich in phenolic compounds and fatty acids with significant antioxidant and anti-inflammatory activity. From these results, an added economical value to this agroindustrial residue is proposed using techniques environmental friendly.
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Objective: Increasing evidences suggest that dietary Silicon (Si) intake, is positively correlated with bone homeostasis and regeneration, representing a potential and valid support for the prevention and improvement of bone diseases, like osteoporosis. This review, aims to provide the state of art of the studies performed until today, in order to investigate and clarify the beneficial properties and effects of silicates, on bone metabolism. Methods: We conducted a systematic literature search up to March 2013, using two medical databases (Pubmed and the Cochrane Library), to review the studies about Si consumption and bone metabolism. Results: We found 45 articles, but 38 were specifically focused on Si studies. Conclusion: RESULTS showed a positive relationship between dietary Si intake and bone regeneration.
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Background: Hair breakage is a common unrecognized form of hair loss in women most often the result of hair weathering and traumatic grooming practices. Lipids are major determinants of the physical properties of the hair. Synsepalum dulcificum seed oil (MFSO®; Miracle Fruit Oil Co., Miami Beach, Florida), is an exotic fruit oil with physicochemical properties suited to providing a superior ability to reduce hair breakage. Objective: To assess the safety and efficacy of a hair oil containing MFSO and its effects on hair breakage rates. Methods: Healthy, long-haired women (age range: 19-63 years, mean age: 36.7 years, standard deviation: 10.77 years) with excessive hair breakage were randomized in this double-blind, placebo-controlled study to receive MFSO (n=24), vehicle (n=17), or argan oil (n=16). Measurements of hair length, hair diameter, and Hair Mass Index were performed at baseline, Month 4, and Month 8. Hair Breakage Index and the Healthy Hair Index values were calculated from the trichometer measurements, and subject self-assessment questionnaires were conducted. The primary efficacy endpoints were the percent change in Healthy Hair Index 75 and Healthy Hair Index 50 measurements from baseline to the eighth month. Results: The Healthy Hair Index calculations, expressed as percent change from baseline to Month 4 and from baseline to Month 8, revealed that the MFSO® treatment group improved by 103.6 percent and 215.7 percent for the Healthy Hair Index 75 and 133.7 and 188.3 percent for the Healthy Hair Index 50 values, respectively. When compared with the vehicle and the argan oil brand groups, the Healthy Hair Index levels were significantly higher (p < 0.001) for the MFSO® treatment group, indicating a much greater ability to increase the levels of unbroken hairs by reducing hair breakage. With respect to the mean percent improvements from baseline to Month 4 and Month 8, the MFSO® hair oil treatment group was better than each of the other two treatment groups by at least 117.6 percent and 234.9 percent for the Healthy Hair Index 75 and 316.5 percent and 312 percent for the Healthy Hair Index 50 values, respectively, thereby achieving the primary efficacy objective. Subjects favored the MFSO® hair oil treatment, rating it as safe, effective, and aesthetically pleasing. Conclusions: The MFSO hair oil product is a safe and effective option for the treatment of women suffering from hair breakage and damaged hair.
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Hepatic fibrosis is a leading cause of morbidity and mortality worldwide. Attenuation of fibrogenic process can significantly lower the mortality rate. However, pharmaceutical intervention at fibrogenesis stage remains a major task in medicine. So there is a need for a natural compound to treat hepatic fibrosis. This study was outlined to investigate the anti-fibrotic effect of β-amyrin in dimethylnitrosamine (DMN)-induced hepatic fibrosis male rats. Serum liver function markers (aspartate transaminase, alanine transaminase, alkaline phosphatase and lactate dehydrogenase), oxidative stress markers (malondialdehyde, superoxide dismutase, catalase, glutathione peroxidase, glutathione reduced content and vitamin C), tissue inflammatory marker (tumor necrosis factor α (TNF-α)), apoptosis marker (caspase 3) and fibrolytic marker (tissue inhibitor of metalloproteinase 1 (TIMP-1)) were evaluated before and after β-amyrin treatment in DMN-induced rat. β-Amyrin treatment attenuated the altered levels of the serum enzyme markers produced by DMN and caused a subsequent recovery toward normalization. Oxidative stress markers and TNF-α levels were reduced significantly (p< 0.001) as well as proteins' (caspase-3 and TIMP-1) expression was reduced in β-amyrin-treated DMN rats. By virtue of β-amyrin properties of inhibiting oxidative stress, apoptosis, inflammation, and fibrogenesis, it might act as an ideal anti-inflammatory and anti-fibrogenic agent to halt the progression of liver fibrosis to chronicity.
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To assess the efficacy and safety of topical Matricaria chamomilla (Chamomile) oil in patients with knee osteoarthritis. Patients were randomized and treated with topical chamomile oil, diclofenac or placebo, 3 times/day for 3 weeks. They were allowed to use acetaminophen as analgesic. The patients were asked about their total acetaminophen use. Moreover, they were assessed in the terms of pain, physical function and stiffness by using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire at the enrolling and weekly. Chamomile oil significantly reduced the patients' need for acetaminophen (P = 0.001) compared with diclofenac and placebo. However, there were no significant differences in WOMAC questionnaire domains. The patients did not report any adverse events by using chamomile oil. Chamomile oil decreased the analgesic demand of patients with knee osteoarthritis. In addition, it may show some beneficial effects on physical function, and stiffness of the patients. Copyright © 2015 Elsevier Ltd. All rights reserved.
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Flavonoids consider as a large group of plant metabolites that 6,000 types of them have been identified till now. In some studies, it has been shown that they can increase aerobic performance and maximal oxygen consumption (VO2 max). The aim of this study was to evaluate the effect of anthocyanin (as one of the most important kind of flavonoids) supplementation on body composition, exercise performance and muscle damage indices in athletes. This double-blinded clinical trial involved 54 female and male athletes at Isfahan University of Medical Sciences with athletic history of at least 3 years. Body composition, exercise performance, creatine kinase, and lactate dehydrogenase were assessed. Individuals were selected by simple sampling method, they divided into two groups using permuted block randomization method. First group received 100 mg anthocyanin pills, and the second group received 100 mg placebo pills, daily for 6 weeks. Participants asked to continue their routine diet and physical activity during the study period, and they were followed through phone calls or text messages. Soft lean mass, total body water and percent body fat were not changed significantly in the anthocyanin group after intervention but VO2 max increased significantly in the anthocyanin group (48.65 ± 4.73 vs. 52.62 ± 5.04) (P ≤ 0.0001), also a significant difference was observed between two studied groups (52.62 ± 5.04 for intervention group vs. 49.61 ± 5.33 for placebo) (P = 0.003). Our findings suggested that the supplementation with anthocyanin in athletes may improve some indices of performance such as VO2 max.
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ScopeThe aim of this study was to investigate the bone regenerative effects of fucosterol in estrogen-deficient ovariectomized (OVX) rats. Methods and resultsBone regeneration was assessed in fucosterol-treated MG63 cells in vitro via assays for osteoblast proliferation, alkaline phosphatase, and osteoclast differentiation. Osteoblast proliferation rates, alkaline phosphatase activity, and mineralization were increased in the fucosterol-treated group. Moreover, differentiation of osteoclasts was decreased in the fucosterol-treated group. In the in vivo assay, female rats were OVX. Twelve weeks after ovariectomy, rats were divided into seven groups, each oral administrate everyday for 7 weeks. The bone mineral density of femoral bones was higher in fucosterol groups than in OVX control, and body weight was lower in fucosterol groups. Among bone-quality parameters, bone volume/total volume increased and trabecular separation decreased in fucosterol groups relative to the OVX control. Bone formation and resorption were evaluated using the serum biomarkers osteocalcin and CTx. Fucosterol tripled the level of serum osteocalcin relative to the OVX group and reduced the serum level of CTx. Conclusion These results suggest that fucosterol has the dual potentials to activate osteoblasts to stimulate bone formation and suppress differentiation of osteoclasts so as to reduce bone resorption.