Efficacy of Vinh Wellness Collagen on Skin Health

Skin Manifestations Clinical Trial

Official title:

A Randomized, Triple-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy of Vinh Wellness Collagen on Skin Elasticity, Wrinkles, and Moisturizing Effect

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04449159
• Other study ID #: 16ASHV
• Status: Completed
• Phase: N/A
• Start date: November 25, 2016
• Est. completion date: May 16, 2018

Study information

• Verified date: July 2020
• Source: Vinh Hoan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 16, 2018
• Est. primary completion date: May 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Skin Abnormalities
• Skin Manifestations

Intervention

Dietary Supplement:
• Vinh Wellness Collagen
Vinh Wellness Collagen is hydrolyzed collagen
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	KGK Science Inc	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Vinh Hoan Corporation	KGK Science Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks from baseline
Secondary	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.	12 weeks from baseline
Secondary	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.	12 weeks from baseline
Secondary	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.	12 weeks from baseliine
Secondary	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.	12 weeks from baseliine
Secondary	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	Baseline, week 6 and week 12.
Secondary	Biological elasticity	This is a measure of skin recovery after deformation. The difference in cheek skin elasticity, measured as biological elasticity (R7), between Vinh Wellness Collagen and placebo supplemented participants after 12 weeks. 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	Baseline, week 6 and week 12.
Secondary	Viscoelastic recovery (overall elasticity)	This is a measure of overall skin elasticity. It is calculated using viscous recovery area of the skin relative to the maximum recovery area. Increases in elasticity are considered an improvement.	12 weeks from baseliine
Secondary	Systolic and diastolic blood pressure	Average blood pressure (systolic and diastolic) values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12.	Baseline, week 6 and week 12.
Secondary	Heart rate	Average heart rate values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12.	Baseline, week 6 and week 12.
Secondary	Body weight	Average body weight values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12.	Baseline, week 6 and week 12.
Secondary	Body mass index (BMI)	Average BMI values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12.	Baseline, week 6 and week 12.
Secondary	Complete blood count (CBC)	Average CBC values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline and week 6, baseline and week 12 as well as week 6 and week 12.	Baseline, week 6 and week 12.
Secondary	Aspartate transaminase (AST)	Average AST values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12.	Baseline, week 6 and week 12.
Secondary	Alanine transaminase (ALT)	Average ALT values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12.	Baseline, week 6 and week 12.
Secondary	Bilirubin	Average bilirubin values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12.	Baseline, week 6 and week 12.
Secondary	Sodium ion	Average sodium ion values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12.	Baseline, week 6 and week 12.
Secondary	Potassium ion	Average potassium ion values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12.	Baseline, week 6 and week 12.
Secondary	Chloride ion	Average chloride ion values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12.	Baseline, week 6 and week 12.
Secondary	Creatinine	Average creatinine values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12.	Baseline, week 6 and week 12.
Secondary	eGFR	Average eGFR values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12.	Baseline, week 6 and week 12.