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

Abstract

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.

Full text

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 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.
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 bioactive‐rich 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
the original work is properly cited.
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;1–12. 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, & Hilakivi‐Clarke, 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 & Tristani‐Firouzi, 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 bio‐instrumentation 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 bio‐instrumentation 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, Winter‐Roberts, & 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 right‐handed 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 21–66 years; (b) healthy
volunteers; (c) written informed consent; (d) confirmed as right‐handed
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 double‐blind, placebo‐con-
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 4–6 weeks of treatment (Visit 3), and after
6–10 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 4–6 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 bio‐instrumentation 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 styrene‐ethylene/butylene‐styrene 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
bio‐instrumentation 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 participant‐visit‐hand combination (e.g., Subject 1,
Visit 2, left hand), each test was conducted twice in a test–retest for-
mat (i.e., replicate measurements). Specific clinical procedures were
implemented for the performance of the bio‐instrumentation 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 bio‐instrumentation
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 120‐s 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 20‐s time interval near the beginning (at the 10‐
to 30‐s interval) and end of the test (at the 90‐to 110‐sinterval)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 single‐handed 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 hand‐held 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 0‐to 10‐s and 90‐to 100‐s 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
PSmeasurementwastakenatthe50‐to 60‐sinterval.Thedata
entry and calculations for PS and PSF were the same as with the
GS and GSF.
2.5 |Questionnaires
Participants completed a self‐assessment 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 10–30 s versus at 90–110 s
Explosive power: Number of taps in 1st second. Acceleration: Time from 0–60 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 0–10 s. Fatigue: Max force at 0–10 s versus at 90–100 s
Pinch Strength & Fatigue Strength: Max force at 0–10 s. Fatigue: Max force at 0–10 s versus at 50–60 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 investigator‐generated 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 warm‐up practice period (3–5 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 5‐min 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 two‐sided independent sample t‐tests, 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 one‐way 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. Bio‐instrumentation study data were analyzed using
SAS® Software Version 9.2.
3|RESULTS
Forty‐six healthy right‐handed 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%). Self‐reported
adherence to the study wristband among all subjects was equally high
across the two treatment groups (>90% diary‐logged 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 4–6 (Visit 3) and 2–4 weeks (Visit 4) of use on the left
and right hand, respectively (Figures 2 and 3). With each hand, in 9
of 12 bio‐instrumentation 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 4–6 weeks of no treatment with the right‐hand (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 2–4 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 one‐way 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 one‐way 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 placebo‐controlled, double‐blind,
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 right‐handed 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 self‐assessments 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 one‐way ANOVA F‐test. 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 4–6 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 2–4 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
near‐baseline 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 2–4 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 oil‐based
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 one‐way ANOVA F‐test. 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
push‐ups. Also, several subjects reported that their video‐gaming 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
Right‐handed 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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