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Efficacy of Vinh Wellness Collagen on Skin Health

Primary Purpose

Skin Manifestations, Skin Abnormalities

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Vinh Wellness Collagen
Placebo
Sponsored by
Vinh Hoan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Manifestations

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.)

Sites / Locations

  • KGK Science Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Vinh Wellness Collagen

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 19, 2020
Last Updated
July 20, 2020
Sponsor
Vinh Hoan Corporation
Collaborators
KGK Science Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04449159
Brief Title
Efficacy of Vinh Wellness Collagen on Skin Health
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 25, 2016 (Actual)
Primary Completion Date
May 16, 2018 (Actual)
Study Completion Date
May 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vinh Hoan Corporation
Collaborators
KGK Science Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Manifestations, Skin Abnormalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Vinh Wellness Collagen
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Vinh Wellness Collagen
Intervention Description
Vinh Wellness Collagen is hydrolyzed collagen
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Cheek skin elasticity
Description
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 Outcome Measure Information:
Title
Underarm skin elasticity
Description
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
Title
Cheek Skin hydration
Description
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.
Time Frame
12 weeks from baseline
Title
Nasolabial wrinkles
Description
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
Title
Skin quality using visual analogue scale (VAS) scores
Description
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
Title
Net Skin elasticity
Description
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
Time Frame
Baseline, week 6 and week 12.
Title
Biological elasticity
Description
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
Time Frame
Baseline, week 6 and week 12.
Title
Viscoelastic recovery (overall elasticity)
Description
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.
Time Frame
12 weeks from baseliine
Title
Systolic and diastolic blood pressure
Description
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.
Time Frame
Baseline, week 6 and week 12.
Title
Heart rate
Description
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.
Time Frame
Baseline, week 6 and week 12.
Title
Body weight
Description
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.
Time Frame
Baseline, week 6 and week 12.
Title
Body mass index (BMI)
Description
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.
Time Frame
Baseline, week 6 and week 12.
Title
Complete blood count (CBC)
Description
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.
Time Frame
Baseline, week 6 and week 12.
Title
Aspartate transaminase (AST)
Description
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.
Time Frame
Baseline, week 6 and week 12.
Title
Alanine transaminase (ALT)
Description
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.
Time Frame
Baseline, week 6 and week 12.
Title
Bilirubin
Description
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.
Time Frame
Baseline, week 6 and week 12.
Title
Sodium ion
Description
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.
Time Frame
Baseline, week 6 and week 12.
Title
Potassium ion
Description
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.
Time Frame
Baseline, week 6 and week 12.
Title
Chloride ion
Description
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.
Time Frame
Baseline, week 6 and week 12.
Title
Creatinine
Description
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.
Time Frame
Baseline, week 6 and week 12.
Title
eGFR
Description
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.
Time Frame
Baseline, week 6 and week 12.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Females aged 45 to 60 years BMI between 20.0-29.9 kg/m2 (±1 kg/m2) 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: 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) Double-barrier method Intrauterine devices Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) Vasectomy of partner (shown successful as per appropriate follow-up) Healthy as determined by laboratory results, medical history, and physical exam No known medical or psychological condition that in the investigator's opinion would interfere with study participation Has given voluntary, written, informed consent to participate in the study Displayed visible signs of natural and photoaging in the face, as assessed through skin condition questionnaire at screening Agreed to avoid prolonged exposure to UV radiation for the duration of the study Exclusion Criteria: Women who were pregnant, breastfeeding, or planning to become pregnant during the trial Acute or chronic skin disease (i.e. atopic dermatitis, eczema, rosacea, psoriasis) or dermatological disorders (scars, sunburns, moles) near the test sites Topical medications used near the test area within 6 weeks prior to baseline 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 Application of topical alpha hydroxyl acids near the test site within 28 days of baseline Use of, or planning to use, systemic corticosteroids within 28 days of baseline or during the study Use of natural health supplements for improving the skin (specifically high concentrations of vitamin A, to be assessed on an individual basis) 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) Botulinum toxin A (Botox) injection treatment near the test sites within 2 years of baseline or plan to receive this treatment during the study Filler injection (collagen, hyaluronic acid, etc.) near the test sites within 2 years of baseline or plan to receive this treatment during the study Tattoos on or near the test area Unstable medical conditions Consumption of more than 2 alcoholic drinks /day Alcohol or drug abuse within 6 months of baseline Tobacco use within 1 year of baseline Use of medical marijuana Participation in clinical research trial within 30 days prior to randomization Allergy or sensitivity to study ingredients or who do not consume fish products (i.e. vegetarians) Participants who were on a low protein diet Cognitively impaired and/or unable to give informed consent 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tetyana Pelipyagina, MD
Organizational Affiliation
KGK Science Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
KGK Science Inc
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5R8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Vinh Wellness Collagen on Skin Health

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