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Clinical Study
A Clinical Trial to Investigate the Effect of Cynatine HNS on
Hair and Nail Parameters
Christina Beer,1Simon Wood,2,3 and Robert H. Veghte4
1CB Food Consulting LLC, 320 Sherman Avenue, Salt Lake City, UT 84115, USA
2Food, Nutrition and Health Program, Faculty of Land and Food Systems, University of British Columbia, 2357 Main Mall,
Vancouver,BC,CanadaV6T1Z4
3School of Public Health, Faculty of Health Sciences, Curtin University, Kent Street, Bentley, WA 6102, Australia
4Roxlor Global LLC, 1013 Centre Road, Suite 106, Wilmington, DE 19805, USA
Correspondence should be addressed to Robert H. Veghte; rhv@roxlor.com
Received May ; Accepted September ; Published October
Academic Editor: Dagrun Engeset
Copyright © Christina Beer et al. is is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Objective. A new, novel product, Cynatine HNS, was evaluated for its eects as a supplement for improving various aspects of
hair and nails in a randomized, double-blind, placebo-controlled clinical trial. Methods. A total of females were included and
randomized into two groups. e active group (𝑛=25) received capsules containing Cynatine HNS, comprised of Cynatine brand
keratin ( mg) plus vitamins and minerals, per day, and the placebo group (𝑛=25) received identical capsules of maltodextrin
per day for days. End points for hair loss, hair growth, hair strength, amino acid composition, and hair luster were measured.
Endpointswerealsomeasuredfornailstrengthandtheappearanceofnails.Results. e results show that subjects taking Cynatine
HNS showed statistically signicant improvements in their hair and nails when compared to placebo. Conclusion. Cynatine HNS
is an eective supplement for improving hair and nails in days or less. EudraCT number is --.
1. Introduction
In recent years, the dietary supplement use has increased both
in Europe and in the USA with manyphysicians recommend-
ing their use [,].Asurveyofhealthprofessionalsconducted
in found that % of dermatologists (𝑛 = 300)recom-
mended dietary supplements to patients in relation to skin,
hair, and nail health and % of them personally used sup-
plements []. e use of bioactive ingredients at concentrated
doses found in dietary supplements can eciently modulate
the physiological processes better than the single ingredients
in foods since heat or mechanical treatment of food before
eating can enhance or reduce its bioavailability or activity
[,]. e benets of food constituents may therefore dier
ifthesamebioactivesubstancesarepresentinnutraceutical
formulations. In the case of nails and hairs the classical
route of treatment is the use of topical application as well
as shampoos. Nowadays, another means to improve nails
and hairs is through oral administration (food and dietary
supplements). e advantage of the oral administration route
is that blood delivers nutraceutical bioactive compounds
continuously to all compartments of hairs and nails.
Dierent studies on dietary supplements are arising in
the scientic literature conrming the ecacy of dietary
supplementation on maintaining and improving skin, hairs,
and nails conditions. In , Jacquet et al. []reportedthe
ecacy of a dietary supplement containing mg Shark
Cartilage, . mg vitamin B2,mgvitaminB
5,mgvitamin
B6,.mgvitaminB
8, and mg sh oil (omega PUFA)
on skin, hairs, and nails in two open clinical trials (total
of women). During days of this trial the product
caused improvement in skin hydration, decrease of wrinkle
depth/volume, a signicant decrease of hair loss, and an
improvement of nail conditions. Authors concluded that the
product was eective in improving many signs of aging, such
as skin appearance, nails, and hair. Other studies demonstrate
the ecacy of oral minerals (i.e., zinc and iron) [–], B-
vitamins [,,], and L-cystine [,] on hairs and nails.
Some of these studies demonstrate that oral supplementation
can have a positive eect on hairs or nails while some others
Hindawi Publishing Corporation
e Scientific World Journal
Volume 2014, Article ID 641723, 6 pages
http://dx.doi.org/10.1155/2014/641723
e Scientic World Journal
demonstrate that the lack of nutrient intakes with the diet
has a detrimental role on hairs and nail conditions. However,
some studies lack the dose-relationship eect, employed
methods are not reliable or standardized, and the study design
sometimes does not take the placebo group into account.
Cynatine HNS contains a protein called keratin, in a
peptide form obtained by proprietary processing of New
Zealand sheep wool. is novel ingredient is stable over a
wide range of pH and under conditions of elevated tem-
perature. Keratin protein is one of nature’s richest sources
of cysteine. Based on this, we hypothesized that Cynatine
HNSmayactsynergisticallywiththecells’ownantioxidant
defense, boosting glutathione and other sulfur rich proteins
and peptides. Keratin is the protein from which the majority
of hair and nails are made. In vitro studies have shown
that Cynatine HNS is highly bioavailable making it capable
of delivering keratin peptides to the body, particularly to
thehairandnails.Basedonthis,arandomized,double-
blind, placebo-controlled study was conducted to examine
the ability of Cynatine HNS to improve end points for hair
loss, hair growth, hair strength, amino acid composition, and
theappearanceofhairontheheadaswellasthestrengthand
appearance of nails.
2. Material and Methods
is study was a single-center, randomized, parallel group,
double-blind, placebo-controlled -day intervention study
in subjects with signs of damaged hair and nails conducted
at a single site in Italy (Farcoderm, University of Pavia).
is clinical research study was done in accordance with
the ethical principles for medical research involving human
subjects (Helsinki Declaration, revised in ) and was
approved by the internal ethical committee (Rif. --SB).
Informed consent documents were signed by all participants
aer study details were explained and each participant was
evaluated for inclusion and exclusion criteria evaluated by
dermatologists in the screening phase. Inclusion criteria for
the study included being female and being between and
years old, Caucasian, clinical signs of stressed or damaged
hair, and an agreement not to use other possible cosmetic
treatments which could interfere with the study. Exclusion
criteria included subjects who did not t the inclusion
criteria, pregnant or breastfeeding women, use of a similar
product to the active, and metabolism disorders. Once the
inclusion criteria were met and consent forms were received,
a screening number was assigned and entered into a screening
and enrollment log. A randomization number was then given
to each subject and a nonblinded employee provided the
blinded examiner with the correct product at the beginning
of each treatment period.
Once subjects were enrolled in the study they were
providedwithabaseshampooandconditionertostandardize
the cosmetic habits for evaluation of product eects on hair
as well as instructions. ey were asked to use the base
shampoo for ve days and to return for their baseline visit
(Day ). At baseline, the dermatologist rechecked compliance
of subjects to the protocol, evaluated baseline value for
endpoints to be measured, hair (pull test, anagen/telogen
evaluation, amino acid composition, mechanical properties,
and appearance) and nails (clinical evaluation for nail status
and breakage tendency), and supplied subjects with either
active or placebo capsules and other information needed.
A daily diary was also maintained in order to evaluate the
habitsofthevolunteersinregardtofoodsanddrinksduring
thersttwoweeksofthestudyaswellastobaccohabits.
At the end of the study period a questionnaire was lled
out regarding the participants’ personal opinion about the
treatment (tolerability, acceptability, and ecacy). Subjects
wereaskedtoreturntohavethesameendpointsforhairand
nails measured at , , and days.
e investigational product Cynatine HNS and placebo,
provided by Roxlor Global, LLC, were given to the subjects
as capsules packaged in blister packages. All Cynatine HNS
capsules contained mg Cynatine (keratin), . mg zinc,
. mg vit amin B3, . mg copper, . mg vitamin B5,
. mg vitamin B6,and.mgvitaminB
8(Biotin) on
an active dose basis. Each placebo capsule, identical in
size, shape, and color, contained the inactive ingredients
maltodextrin mg and magnesium stearate . mg. On
Day,subjectswereinstructedtotaketwocapsulesdailyin
the morning aer breakfast.
All subjects known to have started treatment and who
returned to the clinic for at least one follow-up visit were
included in the analyses. e Cynatine HNS group had one
withdrawal aer Day giving an 𝑁value of for Day
and for Days and . e placebo group had one
withdrawal aer Day giving an 𝑁value of for Days
andandforDay.Intragroupcomparisonsweremade
using Student’s 𝑡-test and intergroup values were determined
using Mann Whitney 𝑈Tes t .
e eects of both the active and placebo groups were
measured on hair using ve separate tests. ese tests were a
pull test, an anagen/telogen evaluation of the hair, the amino
acid composition of the hair, the tensile strength of the hair,
and the clinically evaluated appearance of the hair.
e pull test helps evaluate diuse scalp hair loss. Gentle
traction was exerted on a bunch of hairs (about ) in three
areas of the scalp (frontal, temporal, and occipital) and the
number of extracted hairs was counted. e dermatologist
takesafewstrandsbetweenhis/herthumbandforenger
and pulls them gently. In anagen phase, growing hair should
remain rooted in place while hair in the telogen phase should
comeouteasily.Ifthenumberoflosthairsisgreaterthan,
pull test is positive and suggestive of telogen euvium. e
subjects were asked to refrain from washing their hair -
days before the pull test.
Anagen/telogen testing is performed by choosing a tar-
geted area (mid-vertex) of approximately . cm2for clipping
hair, which was dyed for gray and fair colored hair. Close-up
digital photographs were immediately taken aer shaving and
days later. e two photographs were compared by soware
thatwasabletodetermineifhairwasinanagenphase
(growing)ortelogenphase(notgrowing).Fortheaminoacid
composition of the hair, hair samples were hydrolyzed in M
HCl aqueous solution. Amino acids were then separated by
reverse-phase liquid chromatography and identied in an X-
LC uorimeter (model FP). e amino acids measured
e Scientic World Journal
for this test are serine, glutamic acid, cystine, and methionine.
e breakage force of a single hair ber was evaluated by a
dynamometer (Tensolab A, Mesdan Lab). An average of
readings is reported.
e hair appearance is evaluated by a licensed derma-
tologist who assigns a value of one to three based upon the
subject’s hair brightness and luster. A score of is dull and
devoid of brightness, a score of is basically dull and not so
bright, and a score of is shiny and bright.
e nail appearance and tendency to break were eval-
uated by a licensed dermatologist. e appearance of the
nails is recorded in either/or categories. ese cate-
gories are Hard/So, Resistant/Fragile, Broken/Not Broken,
Rough/Smooth, and Yellowish/White. e nails tendency to
break is evaluated on Day with a score of one to three. A
scoreofindicatesthatnailsareaked,arebroken,orhave
a tendency to break, a score of means nails are moderately
aked, broken, and a score of indicates that neither nails
are aked, broken nor do they have a tendency to break. At
Days , , and , the nails tendency to break is measured
via a four-point scale. A score of is no improvement,
is slight improvement, is moderate improvement, and
is remarkable improvement. For the nail tendency to break
measures, a subject with a score of initially is not included
in the analysis as there is no room for improvement. Eight
subjects on Cynatine HNS had scores of , which lowers the
respective 𝑁values by eight for each measure. Placebo had
subjects with initial scores of , lowering the respective 𝑁
values by for this calculation.
Toevaluatethefactthatthestatisticalanalysiswas
accurateandreliableandthatthesamplesizewaslarge
enough to detect variation of the measured parameter a post
hoc power analysis was performed. e output of the power
analysis clearly indicated that the sample sizes were large
enough (power of at least %) to detect the dierences
obtained before and aer treatment.
3. Results
3.1. Hair Measurement Results
Hair Pull Test.esubjectsintheplacebogroupshowedno
change in number of hairs lost during the study time points
and days. However, at the end of the study period
there was a signicant improvement compared to baseline
(𝑃 < 0.01). Subjects on Cynatine HNS showed a statistically
signicant improvement in reducing hair loss throughout
the test period. A statistically signicant improvement was
already seen within the Cynatine HNS group at Day (𝑃<
0.001) with a .% improvement. is further improved
within the Cynatine HNS group at Day (.%, 𝑃 < 0.001)
and Day (.%, 𝑃 < 0.001). e Cynatine HNS group was
trending towards signicance at Day (𝑃 = 0.07)andwas
statisticallysignicantatDaysand(𝑃 < 0.001 for both)
when compared to placebo. Overall, Cynatine HNS showed
a .% reduction in hair loss over placebo at Day and a
.% and .% reduction at Days and , respectively.
Figure showstheresultsforbothgroupsoverthe-day
time period.
Cynatine
0.0
−5.0
−10.0
−15.0
−20.0
−25.0
−30.0
−35.0
−40.0
−45.0
−50.0
Mean reduction in hair pull test (%)
Day 30 Day 60 Day 90
∗∗∗
∗∗
Placebo
(%)
∗∗∗‡
∗∗∗‡
F : Mean percent reduction in hair pull test from baseline for
placebo and Cynatine HNS. ∗∗𝑃 < 0.01 and ∗∗∗𝑃 < 0.001 within
group to baseline; ‡𝑃 < 0.001 between groups to baseline.
Anagen/Telogen Test.esubjectsintheplacebogroup
showed no change in either anagen (growth phase) or telogen
(nongrowth phase) phase of the hair cycle aer days.
Subjects on Cynatine HNS showed statistically signicant
improvement in their anagen/telogen ratio. Both the telogen
and anagen phases improved at Day by .% (𝑃 < 0.001)
compared to baseline. is was also a statistically signicant
improvementcomparedtoplaceboattheendofthetest
period (𝑃 < 0.001).
Amino Acid Prole.Subjectstakingplaceboshowedno
improvement in the amino acid ratio of serine, glutamic acid,
cystine, and methionine. At the end of the test period at
days the subjects on the active Cynatine HNS treatment
showed a statistically signicant increase in all amino acids
based on their ratio to total protein content. At Day ,
the mean percent increase of serine was .% (𝑃 < 0.001),
glutamic acid .% (𝑃 < 0.001), cystine .% (𝑃 < 0.001),
and methionine .% (𝑃 < 0.001)comparedtobaseline.At
Day these concentrations were all signicantly dierent to
placebo (𝑃 < 0.001). e increase of the amino acid ratio,
especially of cystine which is a main component of Cynatine,
also shows the bioavailability of Cynatine in the body. Figure
shows the results for both groups at baseline and Day .
Hair Tensile Strength.Subjectsonplaceboshowednostatisti-
cal improvement in their hair strength at the end of the test
period.eactivegrouptreatedwithCynatineHNSshowed
a .% improvement in hair strength at Day (𝑃 < 0.001)
compared to baseline as well as a statistically signicant
percent change to placebo at the end of the test period (𝑃<
0.001).
Hair Appearance. Both groups in this test started with a
mean score of 1.70 ± 0.5.Subjectsonplaceboshowedno
improvementinthemeanscoreatDayandanincrease
of . (𝑃 < 0.01) at Day and no further improvement
atDay.SubjectswhoweretreatedwithCynatineHNS
showed a statistically signicant improvement at all times
measured compared to both baseline and placebo. At Day
themeanincreaseinappearancescoreswas.(𝑃 < 0.01),
e Scientic World Journal
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
9.0
10.0
Day 90 Day 90 Day 90 Day 90
Methionine
Cynatine
Placebo
Mean change in amino acid prole (%)
∗∗
−1.0
Serine Glutamic acid Cystine
(%)
∗∗∗‡ ∗∗∗‡
∗∗∗‡
∗∗‡
F : Mean percent change in amino acid prole from baseline
for placebo and Cynatine HNS. ∗∗𝑃 < 0.01 and ∗∗∗𝑃 < 0.001 within
group to baseline; ‡𝑃 < 0.001 between groups to baseline.
∗∗∗∗
∗
∗
0.00
0.50
1.00
1.50
2.00
2.50
3.00
3.50
Mean change in hair brightness
Baseline Day 30 Day 60 Day 90
Cynatine
Placebo
Numerical value
†
∗∗∗‡ ∗∗∗‡
F : Mean change in hair brightness from baseline for placebo
and Cynatine HNS. ∗∗𝑃 < 0.01 and ∗∗∗𝑃 < 0.001 within group to
baseline; †𝑃 < 0.05,‡𝑃 < 0.001 between groups to baseline.
at Day it was . (𝑃 < 0.001), and at Day it was .
(𝑃 < 0.001) when compared to baseline. e results at all
time points are also statistically signicant to placebo (Day
𝑃 < 0.05,Day𝑃 < 0.001,andDay𝑃 < 0.001). e
percent improvement compared to placebo was .% at Day
, .% at Day , and .% at Day . It also should be
noted that out of subjects showed an improvement with
CynatineHNS,whileonlyofshowedanyimprovement
on placebo. e results at all times points for both groups are
shown in Figure .
3.2. Nail Measurement Results
Nails Tendency to Break.Subjectsonplaceboshowedno
statistical improvement over the -day time frame. On the
improvement scale used in this test placebo had a score
of . at Day , showing no improvement, and a mean
score of . at Day , showing very limited improvement.
SubjectsonCynatineHNShavescoresof.atDay,.
at Day , and . at Day , showing slight to moderate
improvement in nails according to the grading scale used
in this test. At all three time points the results compared to
placebo were statistically signicant (𝑃 < 0.001). .% of
subjects taking Cynatine HNS showed an improvement in
their nails tendency to break, whereas only .% of subjects
on placebo showed any improvement.
Appearance of Nails. In the Hard/So quality of nails, hard
is the desirable trait. In the placebo group, at baseline .%
of the subjects had hard nails and at Day .% had hard
nails. In the Cynatine HNS group, at baseline .% had hard
nails and at Day .% had hard nails. A resistant nail
is the benecial quality in the Resistant/Fragile measure. At
baseline, the placebo group had .% of its subjects with
resistant nails and at Day .% had resistant nails. In the
Cynatine HNS group, .% had resistant nails at baseline
and.%hadresistantnailsatDay.Anotbrokennail
is the desired result in the Broken/Not Broken measure. At
baseline, % of the placebo group had no broken nails and
.% had no broken nails at Day . At baseline, .% of
the Cynatine HNS group had no broken nails and .% had
no broken nails at Day . In the Rough/Smooth measure,
smooth is the desired trait. At baseline, .% of the placebo
group had smooth nails and at Day .% had smooth
nails. At baseline, .% of the Cynatine HNS group had
smooth nails and by Day % of the subjects had smooth
nails. A white or natural color is desired for the nail and at
baseline .% had this trait in the placebo group compared
to .% at Day . .% of the Cynatine HNS group had
white nails at baseline and by Day % of the subjects
had white nails.
All ve measures of the nails appearance in the Cynatine
HNS group are statistically signicant to both baseline and
placebo by Day and all have a value of 𝑃 < 0.02 or less at
Day . While being still statistically signicant, the 𝑃values
in the appearance measures are larger than other measures
inthestudybecauseofthelimitedroomforimprovementin
many of the measures especially when compared to placebo.
However, when analyzing the number of people showing
improvement where possible, the largest percentage increase
for placebo in any measure is .%. is equates to four
total people showing improvement at most in any measure
on placebo. e lowest nal score in the Cynatine HNS group
is.%inthreeofthemeasures.Inthosethreemeasures,
onlythreepeopletotalintheactivegroupdidnotachieve
the desired result and in the other two measures % of the
subjects achieved the desired result.
3.3. Adverse Events/Withdrawals. ere were no adverse
events reported during the study, with withdrawals. Both
withdrawals were deemed by the principle examiner not to
be related to either the active or the placebo group. Both
withdrawals were because the subject claimed intolerance to
theproduct,butthisoccurredaerdaysintheactivegroup
anddaysintheplacebogroup.Basedonthistheexaminer
determined that it was individual susceptibility that was the
cause of the intolerance. Both the active and the placebo
groups were well tolerated in study with % of the subjects
nishing the study saying they were well tolerated. Subjects
in the active group also gave the product either an excellent
or a good score in the products acceptability. Based on this,
e Scientic World Journal
CynatineHNSwasfoundtobesafeandwelltoleratedinthis
study.
4. Discussion and Conclusion
A eutrophic eect for hair on the head was seen aer
months of treatment. is was demonstrated by the decrease
of hair shedding in the pull test. e Cynatine HNS group
showed signicantly less hair loss aer , , and days
which were signicantly dierent to the placebo group. is
could be explained by the improvement of the anagen and
telogen phases of the hair. In the Cynatine HNS group
both growth phase (anagen) and stationary phase (telogen)
improved resulting in less hair being pulled out. is was
not seen in the placebo group. Amino acid composition of
serine, glutamic acid, cystine, and methionine improved in
the Cynatine HNS group signicantly to give the hair a better
quality. is can be explained by the addition of the various
bioavailable amino acids from keratin, which is part of the
Cynatine HNS formula. With an improvement in the hair
quality its mechanical properties also improved signicantly
atDaycomparedtoplacebo.Eventheclinicalevaluation
by the physician concluded that hair shininess and brightness
hadimprovedintheCynatineHNSgroupin.%ofthe
subjects compared to only .% in the placebo group. An
overall assessment of hair brightness showed a .% change
compared to only .% in placebo. is is more than a x
improvement in hair brightness at the end of the test period.
Nails also improved their condition aer , , and
months of treatment as demonstrated by the increase of the
subjectshavinghardandresistantnailsandthedecreaseof
the subjects having broken and roughened nails. Hardness
of nails improved from .% of subjects reporting hard nails
to.%attheendofdays.atgoeshandinhandwith
the improvement in resistance and none broken nails. e
placebo group scored in all categories below %. As the
nails improved in hardness and resistance they also improved
signicantly in smoothness at Day compared to placebo.
ey also changed to a more normal color than the yellow
discoloration seen. e clinical evaluation by a physician also
went along the same lines and an improvement in tendency
to break was seen in .% of subjects as compared to only
.% in the placebo group.
In a questionnaire administered aer completion of the
study, participants were asked to rate how eective they
felt the products were. Not surprisingly, the placebo scored
poorly in the questionnaire as .% of the participants felt
that it was ineective for hair and .% felt that it was poor
for nails. In the Cynatine HNS group, .% of the partici-
pantsfeltthattheproductwassucientforhairwith%
feeling that the product was either very good or excellent. For
nails, .% of the Cynatine HNS group felt that the product
was sucient with .% nding it very good or excellent.
Basedontheresultsofthisstudy,itwouldberecom-
mended that further clinical analysis should be performed
on Cynatine HNS. In order to better analyze the eect of
Cynatine HNS on hair and nails a study which includes
men and women, a larger sample size, and a longer duration
should be performed. Additionally it would be benecial
to look at a comparison of Cynatine with and without the
additional vitamins and minerals.
In conclusion, the results obtained for the Cynatine
HNS group were statistically dierent from that obtained
for the placebo group, demonstrating that Cynatine HNS
had a signicant inuence on the quality of skin, hair, and
nails. Cynatine HNS contains ingredients that are all seen as
nutrients for skin, hair, and nails. Keratin is a major structural
component of the hair and nails which can be seen by the
inuence Cynatine HNS has on the quality of hair and nails.
Conflict of Interests
Robert H. Veghte is the General Manager of Roxlor Global,
LLC. Neither Christina Beer nor Simon Wood is an employee
of Roxlor Global, LLC, nor do they receive any royalty or
payment based on performance of the product; they do
however receive consulting fees on a per job basis f rom Roxlor
Global, LLC.
Acknowledgment
e authors would like to thank Roxlor Global, LLC, for
providing all the raw materials in this study. Roxlor Global,
LLC, funded this study.
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