Efficacy of Vinh Wellness Collagen on Skin Health

Vinh Hoan Corporation50 enrolled

Overview

The most visible signs of aging are on the skin. As skin gets older it shows a decrease in epidermal thickness, with a flattening of the dermal-epidermal junction. At the same time, loss of elasticity and wrinkle formation begin. The objective of this randomized, triple-blind, placebo-controlled study is to evaluate the efficacy of Vinh Wellness Collagen on skin elasticity, wrinkles, and hydration over 12 weeks.

Skin appearance is known to be influenced by endogenous and environmental factors, including nutrition, hormones, as well as exposure to chemicals, smoking, or ultraviolet radiation. The ability of nutritional supplements to enhance skin characteristics has received increasing attention as the population continues aging. A recent study assessed the correlation between nutrient consumption and skin-aging appearance, including skin wrinkles, dryness, and atrophy, and determined that higher intake of linoleic acid and vitamin C, as well as lower intake of fats and carbohydrates are linked with improved skin appearance. Moreover, clinical trials examining the effects of nutritional supplementation with proteins, vitamins, fatty acids, and trace minerals, have suggested that dietary compounds can modulate skin health and function. As skin gets older it shows a decrease in epidermal thickness, with a flattening of the dermal-epidermal junction. The dermis is the skin layer directly below the epidermis and has decreases in thickness by about 1% per year throughout the adult lifespan. Structural components of the dermis include collagen, elastic fibers, and extrafibrillar matrix. The cosmetic industry has focused its research on supporting these connective tissue components, as they have been established to repair skin damage (i.e. wounds) and enhance the strength and radiance of the skin. Collagen is the most abundant protein in mammals and is currently being utilized by a diverse number of industries including nutrition, cosmetic, and biomedical fields. Gelatin, which is used extensively in the food sector, is a hydrolyzed analog of collagen and is an excellent source of protein. A subsequent enzymatic degradation of gelatin results in the generation of collagen hydrolysate (CH), which contains peptides of an average molecular weight of 3-6 kDa. Human bioavailability studies have demonstrated that hydrolyzed collagen peptides are present in the blood within 2 h following oral ingestion of gelatin derived from chicken or fish and are present up to 24 h later. A double-blind, placebo-controlled trial on 69 women treated with a daily CH treatment or placebo for 8 weeks reported that skin elasticity was significantly improved. Skin moisture and skin evaporation were also enhanced but did not reach statistical significance relative to the placebo group. In addition, other studies have examined the effect of daily ingestion of CH (10 g) or placebo on skin hydration in healthy Japanese women over 2 months and found that there was a gradual improvement in skin water absorption capacity. The objective of this randomized, triple-blind, placebo-controlled study is to evaluate the efficacy of Vinh Wellness Collagen, a CH derived from pangasius skin, on skin elasticity, wrinkles, and hydration over 12 weeks of use.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Skin Manifestations Skin Abnormalities

Interventions

Vinh Wellness CollagenDIETARY_SUPPLEMENT

Vinh Wellness Collagen is hydrolyzed collagen

PlaceboDIETARY_SUPPLEMENT

Placebo

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Females aged 45 to 60 years 2. BMI between 20.0-29.9 kg/m2 (±1 kg/m2) 3. Female participant was not of child bearing potential, defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation, or are post-menopausal (natural or surgically with \> 1 year since last menstruation) OR Females of childbearing potential agreed to use a medically approved method of birth control and have a negative urine pregnancy test result. A minimum of 3-months stable dose was required for females on a hormonal birth control. Acceptable methods of birth control included: 1. Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) 2. Double-barrier method 3. Intrauterine devices 4. Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) 5. Vasectomy of partner (shown successful as per appropriate follow-up) 4. Healthy as determined by laboratory results, medical history, and physical exam 5. No known medical or psychological condition that in the investigator's opinion would interfere with study participation 6. Has given voluntary, written, informed consent to participate in the study 7. Displayed visible signs of natural and photoaging in the face, as assessed through skin condition questionnaire at screening 8. Agreed to avoid prolonged exposure to UV radiation for the duration of the study Exclusion Criteria: 1. Women who were pregnant, breastfeeding, or planning to become pregnant during the trial 2. Acute or chronic skin disease (i.e. atopic dermatitis, eczema, rosacea, psoriasis) or dermatological disorders (scars, sunburns, moles) near the test sites 3. Topical medications used near the test area within 6 weeks prior to baseline 4. Use of tretinoin, adapalene, tazarotene or other topical medications for the treatment of skin aging near the test site during the 12 weeks preceding baseline 5. Application of topical alpha hydroxyl acids near the test site within 28 days of baseline 6. Use of, or planning to use, systemic corticosteroids within 28 days of baseline or during the study 7. Use of natural health supplements for improving the skin (specifically high concentrations of vitamin A, to be assessed on an individual basis) 8. Planned or unavoidable exposure to intense ultraviolet (UV) radiation during the study (such as sun tanning salons, vacations in a sunny climate or outdoor worker) 9. Botulinum toxin A (Botox) injection treatment near the test sites within 2 years of baseline or plan to receive this treatment during the study 10. Filler injection (collagen, hyaluronic acid, etc.) near the test sites within 2 years of baseline or plan to receive this treatment during the study 11. Tattoos on or near the test area 12. Unstable medical conditions 13. Consumption of more than 2 alcoholic drinks /day 14. Alcohol or drug abuse within 6 months of baseline 15. Tobacco use within 1 year of baseline 16. Use of medical marijuana 17. Participation in clinical research trial within 30 days prior to randomization 18. Allergy or sensitivity to study ingredients or who do not consume fish products (i.e. vegetarians) 19. Participants who were on a low protein diet 20. Cognitively impaired and/or unable to give informed consent 21. Any other condition which in the Investigator's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual (e.g. cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)

Locations (1)

KGK Science Inc

London, Ontario, Canada

Outcomes

Primary Outcomes

Cheek skin elasticity

Cheek skin elasticity will be measured using the Cutometer® (MPA 580), which applies the suction method of negative pressure. The skin is drawn into the aperture of the probe using negative pressure, and after a defined time, is released again. The resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) are displayed as curves (penetration depth in mm/time) in real time during the analysis.The difference in cheek skin elasticity, measured as Gross skin elasticity (R2), between Vinh Wellness Collagen and placebo supplemented participants after 12 weeks. Cheek skin elasticity will be on a scale of 0-100; 0= no improvement, 100 = great improvement.

Time frame: 12 weeks from baseline

Secondary Outcomes

Underarm skin elasticity

Underarm elasticity will be measured using the Cutometer® (MPA 580), which applies the suction method of negative pressure. The skin is drawn into the aperture of the probe using negative pressure, and after a defined time, is released again. The resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) are displayed as curves (penetration depth in mm/time) in real time during the analysis. The difference in underarm skin elasticity between Vinh Wellness Collagen and placebo supplemented participants after 12 weeks. Underarm skin elasticity will be on a scale of 0-100; 0= no improvement, 100 = great improvement.

Time frame: 12 weeks from baseline

Cheek Skin hydration

Cheek skin hydration is evaluated by the Corneometer® (CM 825) using the capacitance method, which is based on the different dielectric constant of water and other substances. Using the corneometer probe, an electric scatter field penetrates ting during the measurement and the dielectricity is determined. The results are stored on the device software as arbitrary units. The difference in cheek skin hydration between Vinh Wellness Collagen and placebo supplemented participants after 12 weeks. Cheek skin hydration will be on a scale of 0-100; 0= no improvement, 100 = great improvement.

Data from ClinicalTrials.gov

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Time frame: 12 weeks from baseline

Nasolabial wrinkles

Nasolabial skin wrinkles will be measured by the Modified Fitzpatrick Wrinkle Scale using images acquired by VISIA imaging which utilizes multi-spectral imaging and analysis capture visual information for wrinkles. The difference in nasolabial wrinkles between placebo and Vinh Wellness Collagen participants after 12 weeks of supplementation. The Modified Fitzpatrick Wrinkle Scale (MFWS) is a validated questionnaire that can evaluate skin wrinkle severity. It is on a scale of 0-3; 0 = no wrinkle, 3 = deep wrinkle.

Time frame: 12 weeks from baseliine

Skin quality using visual analogue scale (VAS) scores

Skin quality takes account of different measures including skin elasticity, skin hydration, radiance of skin, skin firmness, skin wrinkles and overall feel of skin. Each of these parameters are measured on a scale of 0 - 100; 0 = no improvement. 100 - great improvement. The difference in skin quality VAS scores between placebo and Vinh Wellness Collagen supplemented participants after 12 weeks of supplementation ona scale of 0 - 100; 0 = no improvement, 100 - great improvement.

Time frame: 12 weeks from baseliine

Net Skin elasticity

The difference in cheek skin elasticity measured as Net Skin elasticity (R5), between Vinh Wellness Collagen and placebo supplemented participants after 12 weeks. Net skin elasticity is the elastic (immediate stretch) component of the skin without the viscous deformation. Data is represented as the difference between baseline and week 6, baseline and week 12 and between week 6 and week 12. A negative value indicates loss of skin elasticity while a positive number denotes an improved elasticity