Maryam Borumand1, Sara Sibilla1*
Abstract: Hydrolysed collagen consists of small peptides with low molecular weight, produced from native collagen found in bones, skin and connective tissue of animals, such as cattle, pigs and fish. Due to its low molecular weight, hydrolysed collagen is highly digestible, easily absorbed and distributed in the human body. If ingested, collagen peptides have been shown to be absorbed in the gut and delivered to the skin and joints. In-vitro and in-vivo studies have shown this may impact the skin ageing process. A double-blinded, randomised, placebo controlled study including 108 healthy volunteer subjects was performed to assess the efficacy of an anti-ageing food supplement containing high dosage of hydrolysed collagen, called Pure GOLD COLLAGEN®. Volunteers consumed the products daily for 12 weeks. Most subjects agreed Pure GOLD COLLAGEN® improved the condition of their skin, hair, nails and joints. The effect on the skin was investigated on a sub-group of the volunteers andsignificant improvements in the wrinkles were achieved, primarily in the surface area and length of wrinkles. Daily oral consumption of Pure GOLD COLLAGEN® for up to 12 weeks does lead to a detectable improvement in skin health. The observations noted in this preliminary study indicate that Pure GOLD COLLAGEN® is effective in improving the appearance of wrinkles of multiple depths and lengths.
INTRODUCTION
The natural ageing process, termed intrinsic ageing, causes
collagen fibres to become thicker and much shorter,
leading to an increase in breakdown of collagen type I. [1]
Collagen type I is the main component of human skin
(80%) with collagen type III making up the remainder of
skin collagen (15%). [2, 3] Another important skin component
is hyaluronic acid. This is a high molecular weight
polysaccharide, found mainly in the extracellular matrix of
[4]connective tissues.
The aging process starts around mid-twenties and
becomes more pronounced later in life. Both intrinsic and
extrinsic ageing processes are controlled, respectively, by
genetic variations and by extrinsic components including
smoking, alcohol consumption and chronic sun exposure, [5]
all of which increase the level of free radicals (reactive
oxygen species, ROS) in the dermis, the deepest layer of the
skin. ROS induce molecular destruction and consequently
the loss of biological functions. [6] The formation of
wrinkles, the appearance of brown spots and the
thickening of the skin. [7, 8] Also, bony landmarks and blood
vessels become more visible.
Many techniques, which can effectively combat visible
signs of ageing: microderm abrasion, peels, lasers, photorejuvenation,
fillers, botulinum toxin type A. However,
these procedures can be expensive and some people are
put off by the invasive nature of some of the treatments.
The alternative is topical application of creams, lotions and
serums. Several topical agents have been able to partially
reverse photo-ageing; the retinoids are the most widely
studied, followed by α-hydroxy acids [9, 10] and antioxidants
(topical vitamin C, vitamin E, copper). [11, 12] Unfortunately,
not all formulations are able to penetrate the thick
epidermal layer in order to fight the appearance of
wrinkles, which initiate much deeper in the skin.
Hydrolysed collagen consists of small peptides with low
molecular weight (0.3 to 8 kDa), produced from native
collagen found in bones, skin and connective tissue of
animals, such as cattle, pigs and fish. The quality of the final
hydrolysed collagen is dependent on its average molecular
size, which can vary based on the methodology used to
extract it. Generally, collagen molecules are denatured and
partially hydrolysed to form gelatin (100 kDa). Gelatin can
then be decomposed into small peptides using specific
enzymes with cleavage activity (proteinase). Due to its low
molecular weight, hydrolysed collagen is highly digestible,
easily absorbed and distributed in the human body.
Proksch and colleagues investigated the effects of
collagen hydrolysate on skin biophysical parameters
related to cutaneous ageing, such as skin elasticity, skin
moisture, trans epidermal water loss and skin roughness.
In this double-blind, placebo-controlled study, 69 women
aged between 35 and 55 years were randomized to receive
collagen hydrolysate (2.5 g or 5.0 g) or placebo once daily
for 8 weeks. At the end of the study skin elasticity in both
collagen hydrolysate dosage groups showed a statistically
significant improvement in comparison to placebo. With
regard to skin moisture and skin evaporation, a positive
influence of collagen hydrolysate treatment could be
observed in a subgroup analysis. No side effects were noted
throughout the study. [13]
In this article we present a study to investigate the
efficacy of an oral liquid nutritional supplement containing
hydrolysed collagen and its effect on improving the
appearance of wrinkles. The product tested is called Pure
GOLD COLLAGEN®.
MATERIALS AND METHODS
To assess the efficacy of Pure GOLD COLLAGEN®, a double
blind, parallel group, placebo controlled randomized
clinical study was carried out on 108 healthy volunteer
subjects over a 12 week period. The objective of this trial
was to evaluate the effect of daily oral intake of 50 ml of
Pure GOLD COLLAGEN® on skin, hair, nails and joints
through observational assessment.
All procedures followed were in accordance with the
ethical standards of the responsible committee on human
Ingredients in Product A (Pure GOLD COLLAGEN®)
Water
Hydrolysed collagen
Glucose fructose syrup
Citric acid
Soybean polysaccharide (stabiliser)
Malic acid
Ascorbic Acid (vitamin C)
Flavouring substances (peach flavour)
Hyaluronic acid
Borage oil emulsion (Borage oil 20%)
d-alpha-tocopherol (vitamin E)
N-acetylglucosamine
Sucralose
Zinc gluconate
Pyridoxine hydrochloride (vitamin B6)
Piper nigrum (Black pepper extract)
Copper (cupric gluconate)
D-Biotin
Vitamin D3
Ingredients in Product B (Placebo)
Water
Glucose fructose syrup
Citric acid anhydrous
Stabiliser (Soybean polysaccharide)
Peach flavour
DL-Malic acid
Sucralose
Table 2: Observational Assessment, Questionnaire Results for Product A Compared to Placebo on Week 12
Percentage of People taking Pure GOLD COLLAGEN® Compared to Placebo
who Agreed with the Benefits Stated in the Questionnaire
66% more people using Pure GOLD COLLAGEN®, compared to placebo, agree skin is more elastic
121% more people using Pure GOLD COLLAGEN®, compared to placebo, agree stretch marks are reduced
113% more people using Pure GOLD COLLAGEN®, compared to placebo, agree hair is thicker
52% more people using Pure GOLD COLLAGEN®, compared to placebo, agree hair is less brittle
35% more people using Pure GOLD COLLAGEN®, compared to placebo, agree nails are less brittle
64% more people using Pure GOLD COLLAGEN®, compared to placebo, agree joint pain is reduced
experimentation (institutional and national) and with the
Helsinki Declaration of 1975, as revised in 2000 and 2008.
The procedures were explained and an informed written
consent was presented to and signed by each participant
for being included in the study. Subjects were randomly
assigned to 2 groups; one group was given product A
(Pure GOLD COLLAGEN®) and the other product B
(placebo; Table 1). Those with an allergy to any of the
ingredients to the test products likely to interfere with the
study were excluded. The product was distributed to the
participants according to their respective group identity,
A or B. Instructions related to product ingestion were
given to the participants; the supplement was to be taken
daily, for a period of 12 weeks, in the morning before
breakfast. Subjects were required to continue with their
regular use of moisturisers, cosmetics, wash products and
toiletries during the course of the study. Subjects were
asked to avoid direct sunlight or sun beds during the
course of the study. The subjects’ view of the oral
supplement was compared before and after treatment
through analysis of information obtained from selfevaluation
questionnaires.
The anti-wrinkle efficacy of the supplement was further
tested on 17 of the subjects. These were healthy Caucasian
female subjects, aged 45 to 64 years. Subjects with a recent
history (previous 12 months) of significant skin disease e.g.
eczema, were excluded. Nine subjects from group A and 8
subjects from group B completed the study. Change in
wrinkle parameters was assessed by the investigator using
Visioline® (www. courage-khazaka.de) on week 0, 3, 6, 9
and 12. The following parameters were analysed: total
surface area of wrinkles (in μm2), total length and mean
length of wrinkles (in μm). Statistical analysis was carried
out on such parameters. The results were compared with
those obtained on day 0 for each group and between
groups, using Wilcoxon test and Mann-Whitney U-test,
respectively.
RESULTS
Observational Assessment
A questionnaire comprised of two parts was provided to
the 108 subjects. The first section was completed by the
subjects at baseline (Week 0) and the second section was
completed by subjects at the end of the trial (Week 12).
The treatment generated favourable comments from the
volunteers. The test product was favoured at a high level
(Table 2).
Area Occupied by Wrinkles
The area occupied by wrinkles was significantly (p ≤ 0.05)
reduced by 19% after 9 weeks in the group treated with
product A (Figure 1A). This was not observed for subjects
treated with placebo. The difference between the treated
group and placebo was not significant.
Moreover, the significant improvement detected with
product A at week 9 exhibited a correlation with baseline
Figure 1: (A) Comparative profilometry results for total area of
wrinkles in patients using product A (in red) or placebo (in blue).
(B) Percentage decrease at 9 weeks against total area of wrinkles
at baseline. Stars indicate significance of p≤0.05 when compared
with week 0
wrinkle surface area: the higher the initial area, the greater
the reduction at week 9 (Figure 1B).
Mean Length of Wrinkles
The mean length of wrinkles was significantly reduced
(p≤0.05) by 19% after 9 weeks in the patients using
product A (Figure 2A).
Total Length of Wrinkles
The total length of wrinkles in patients using product A was
significantly reduced by 10% after 9 weeks (p≤0.05; Figure
2B). A significant difference was not observed between
patients using placebo and those taking the product.
In summary, significant reductions in wrinkle
parameters were measured in patients using product A.
These reductions were progressive over time, with
improvements of 19% reduction in total surface area and
mean length of wrinkles and 10% reduction in total
wrinkle length by week 9. Even though improvements were
also observed with placebo, these were to a lesser degree
and were not progressive.
DISCUSSION
Detailed analysis of the numerical measurements recorded
during the clinical study show that daily oral consumption
of product A for up to 12 weeks does lead to a detectable
improvement in skin health. The clinical trial results verify
Figure 2: Comparative profilometry results for mean length of
wrinkles (A) and total length of wrinkles (B) in patients using
product A (in red) or placebo (in blue). Stars indicate significance
of p≤0.05 when compared with week 0
that regular intake of product A improves the basic skin
condition. Indeed, out of 108 subjects 66% more subjects
taking product A compared to placebo confirmed that their
skin became more elastic. Apart from elasticity, over twice
as many more subjects (121%) taking product A agreed
that their stretch marks had reduced compared to placebo
group. These results indicate that product A improves the
overall skin condition and function.
This study also suggests there are benefits of product A
on hair, nails and joints. In fact, 113% more subjects taking
product A felt their hair had become thicker. This is most
likely because product A strengthens the hair shaft in the
dermal layer of skin and thus prevents breakage. Indeed,
52% more subjects taking product A compared to placebo
agreed that their hair had become less brittle. In addition
subjects taking product A reported that their nails had
become less brittle; 35% higher than those taking the
placebo drink. From these results it appears that product A
improves all aspects of the skin.
Finally, 64% more subjects who took product A
compared to placebo said their joint pain had reduced,
which indicates that, apart from benefiting skin, hair and
nails, product A may also improve joint health, providing
further evidence that the drink acts on the whole body. We
therefore conclude that oral intake of product A can offer
real benefits to many individuals with ageing skin, hair and
joints.
Significant reductions in wrinkle parameters, including
surface area, total length and mean length, were measured
for patients using product A. Although improvements for
these parameters were also observed in the group using
placebo, they were not as consistent. The average reduction
in the total surface area of wrinkles was 19% at 9 weeks,
almost twice the average reduction associated with
placebo. The mean length and total length of the wrinkles
in group A diminished by 19% and 10%, respectively.
The fact that people taking product A showed consistent
significant decline in area and length of wrinkles at week 9,
a result not seen with placebo, suggests the formula
associated with this product, which contains as active
ingredients hydrolysed collagen and hyaluronic acid,
among other key vitamins, has anti-ageing properties.
The results obtained with product A were found to be
progressive, whereas there was a lack of trend in the
results obtained from the placebo group. Even though an
initial benefit was detected by using placebo, it is unlikely
the improvement observed was due to real physical
changes as it disappeared on further visits.
CONCLUSION
The observations noted in this preliminary study indicate
that product A is effective in improving the appearance of
wrinkles of multiple depths and lengths. It would be of
value to assess the level of wrinkle reduction in a larger
group of people and for a longer period (i.e. beyond the 12
week test period).
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Acknowledgments
The study was funded by MINERVA Research Labs Ltd
(London, UK). The authors wish to thank Dr Martin Godfrey,
who provided valuable comments and assistance to the
writing of the study summarised here.
Cite this article as: Maryam Borumand, Sara Sibilla. A
Study to Assess the Effect on Wrinkles of a Nutritional
Supplement Containing High Dosage of Hydrolysed
Collagen. Inventi Impact: Cosmeceuticals, 2014(3):93-96,
2014.
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