<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04449159</url>
  </required_header>
  <id_info>
    <org_study_id>16ASHV</org_study_id>
    <nct_id>NCT04449159</nct_id>
  </id_info>
  <brief_title>Efficacy of Vinh Wellness Collagen on Skin Health</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vinh Hoan Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KGK Science Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vinh Hoan Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The most visible signs of aging are on the skin. As skin gets older it shows a decrease in&#xD;
      epidermal thickness, with a flattening of the dermal-epidermal junction. At the same time,&#xD;
      loss of elasticity and wrinkle formation begin. The objective of this randomized,&#xD;
      triple-blind, placebo-controlled study is to evaluate the efficacy of Vinh Wellness Collagen&#xD;
      on skin elasticity, wrinkles, and hydration over 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Skin appearance is known to be influenced by endogenous and environmental factors, including&#xD;
      nutrition, hormones, as well as exposure to chemicals, smoking, or ultraviolet radiation. The&#xD;
      ability of nutritional supplements to enhance skin characteristics has received increasing&#xD;
      attention as the population continues aging. A recent study assessed the correlation between&#xD;
      nutrient consumption and skin-aging appearance, including skin wrinkles, dryness, and&#xD;
      atrophy, and determined that higher intake of linoleic acid and vitamin C, as well as lower&#xD;
      intake of fats and carbohydrates are linked with improved skin appearance. Moreover, clinical&#xD;
      trials examining the effects of nutritional supplementation with proteins, vitamins, fatty&#xD;
      acids, and trace minerals, have suggested that dietary compounds can modulate skin health and&#xD;
      function.&#xD;
&#xD;
      As skin gets older it shows a decrease in epidermal thickness, with a flattening of the&#xD;
      dermal-epidermal junction. The dermis is the skin layer directly below the epidermis and has&#xD;
      decreases in thickness by about 1% per year throughout the adult lifespan. Structural&#xD;
      components of the dermis include collagen, elastic fibers, and extrafibrillar matrix. The&#xD;
      cosmetic industry has focused its research on supporting these connective tissue components,&#xD;
      as they have been established to repair skin damage (i.e. wounds) and enhance the strength&#xD;
      and radiance of the skin.&#xD;
&#xD;
      Collagen is the most abundant protein in mammals and is currently being utilized by a diverse&#xD;
      number of industries including nutrition, cosmetic, and biomedical fields. Gelatin, which is&#xD;
      used extensively in the food sector, is a hydrolyzed analog of collagen and is an excellent&#xD;
      source of protein. A subsequent enzymatic degradation of gelatin results in the generation of&#xD;
      collagen hydrolysate (CH), which contains peptides of an average molecular weight of 3-6 kDa.&#xD;
      Human bioavailability studies have demonstrated that hydrolyzed collagen peptides are present&#xD;
      in the blood within 2 h following oral ingestion of gelatin derived from chicken or fish and&#xD;
      are present up to 24 h later.&#xD;
&#xD;
      A double-blind, placebo-controlled trial on 69 women treated with a daily CH treatment or&#xD;
      placebo for 8 weeks reported that skin elasticity was significantly improved. Skin moisture&#xD;
      and skin evaporation were also enhanced but did not reach statistical significance relative&#xD;
      to the placebo group. In addition, other studies have examined the effect of daily ingestion&#xD;
      of CH (10 g) or placebo on skin hydration in healthy Japanese women over 2 months and found&#xD;
      that there was a gradual improvement in skin water absorption capacity. The objective of this&#xD;
      randomized, triple-blind, placebo-controlled study is to evaluate the efficacy of Vinh&#xD;
      Wellness Collagen, a CH derived from pangasius skin, on skin elasticity, wrinkles, and&#xD;
      hydration over 12 weeks of use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 25, 2016</start_date>
  <completion_date type="Actual">May 16, 2018</completion_date>
  <primary_completion_date type="Actual">May 16, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cheek skin elasticity</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Underarm skin elasticity</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cheek Skin hydration</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasolabial wrinkles</measure>
    <time_frame>12 weeks from baseliine</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin quality using visual analogue scale (VAS) scores</measure>
    <time_frame>12 weeks from baseliine</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net Skin elasticity</measure>
    <time_frame>Baseline, week 6 and week 12.</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biological elasticity</measure>
    <time_frame>Baseline, week 6 and week 12.</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viscoelastic recovery (overall elasticity)</measure>
    <time_frame>12 weeks from baseliine</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic and diastolic blood pressure</measure>
    <time_frame>Baseline, week 6 and week 12.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Baseline, week 6 and week 12.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>Baseline, week 6 and week 12.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index (BMI)</measure>
    <time_frame>Baseline, week 6 and week 12.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete blood count (CBC)</measure>
    <time_frame>Baseline, week 6 and week 12.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspartate transaminase (AST)</measure>
    <time_frame>Baseline, week 6 and week 12.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alanine transaminase (ALT)</measure>
    <time_frame>Baseline, week 6 and week 12.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilirubin</measure>
    <time_frame>Baseline, week 6 and week 12.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sodium ion</measure>
    <time_frame>Baseline, week 6 and week 12.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium ion</measure>
    <time_frame>Baseline, week 6 and week 12.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chloride ion</measure>
    <time_frame>Baseline, week 6 and week 12.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine</measure>
    <time_frame>Baseline, week 6 and week 12.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>eGFR</measure>
    <time_frame>Baseline, week 6 and week 12.</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Skin Manifestations</condition>
  <condition>Skin Abnormalities</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Vinh Wellness Collagen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vinh Wellness Collagen</intervention_name>
    <description>Vinh Wellness Collagen is hydrolyzed collagen</description>
    <arm_group_label>Vinh Wellness Collagen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Females aged 45 to 60 years&#xD;
&#xD;
          2. BMI between 20.0-29.9 kg/m2 (±1 kg/m2)&#xD;
&#xD;
          3. Female participant was not of child bearing potential, defined as females who have had&#xD;
             a hysterectomy or oophorectomy, bilateral tubal ligation, or are post-menopausal&#xD;
             (natural or surgically with &gt; 1 year since last menstruation)&#xD;
&#xD;
             OR&#xD;
&#xD;
             Females of childbearing potential agreed to use a medically approved method of birth&#xD;
             control and have a negative urine pregnancy test result. A minimum of 3-months stable&#xD;
             dose was required for females on a hormonal birth control. Acceptable methods of birth&#xD;
             control included:&#xD;
&#xD;
               1. Hormonal contraceptives including oral contraceptives, hormone birth control&#xD;
                  patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable&#xD;
                  contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)&#xD;
&#xD;
               2. Double-barrier method&#xD;
&#xD;
               3. Intrauterine devices&#xD;
&#xD;
               4. Non-heterosexual lifestyle or agrees to use contraception if planning on changing&#xD;
                  to heterosexual partner(s)&#xD;
&#xD;
               5. Vasectomy of partner (shown successful as per appropriate follow-up)&#xD;
&#xD;
          4. Healthy as determined by laboratory results, medical history, and physical exam&#xD;
&#xD;
          5. No known medical or psychological condition that in the investigator's opinion would&#xD;
             interfere with study participation&#xD;
&#xD;
          6. Has given voluntary, written, informed consent to participate in the study&#xD;
&#xD;
          7. Displayed visible signs of natural and photoaging in the face, as assessed through&#xD;
             skin condition questionnaire at screening&#xD;
&#xD;
          8. Agreed to avoid prolonged exposure to UV radiation for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who were pregnant, breastfeeding, or planning to become pregnant during the&#xD;
             trial&#xD;
&#xD;
          2. Acute or chronic skin disease (i.e. atopic dermatitis, eczema, rosacea, psoriasis) or&#xD;
             dermatological disorders (scars, sunburns, moles) near the test sites&#xD;
&#xD;
          3. Topical medications used near the test area within 6 weeks prior to baseline&#xD;
&#xD;
          4. Use of tretinoin, adapalene, tazarotene or other topical medications for the treatment&#xD;
             of skin aging near the test site during the 12 weeks preceding baseline&#xD;
&#xD;
          5. Application of topical alpha hydroxyl acids near the test site within 28 days of&#xD;
             baseline&#xD;
&#xD;
          6. Use of, or planning to use, systemic corticosteroids within 28 days of baseline or&#xD;
             during the study&#xD;
&#xD;
          7. Use of natural health supplements for improving the skin (specifically high&#xD;
             concentrations of vitamin A, to be assessed on an individual basis)&#xD;
&#xD;
          8. Planned or unavoidable exposure to intense ultraviolet (UV) radiation during the study&#xD;
             (such as sun tanning salons, vacations in a sunny climate or outdoor worker)&#xD;
&#xD;
          9. Botulinum toxin A (Botox) injection treatment near the test sites within 2 years of&#xD;
             baseline or plan to receive this treatment during the study&#xD;
&#xD;
         10. Filler injection (collagen, hyaluronic acid, etc.) near the test sites within 2 years&#xD;
             of baseline or plan to receive this treatment during the study&#xD;
&#xD;
         11. Tattoos on or near the test area&#xD;
&#xD;
         12. Unstable medical conditions&#xD;
&#xD;
         13. Consumption of more than 2 alcoholic drinks /day&#xD;
&#xD;
         14. Alcohol or drug abuse within 6 months of baseline&#xD;
&#xD;
         15. Tobacco use within 1 year of baseline&#xD;
&#xD;
         16. Use of medical marijuana&#xD;
&#xD;
         17. Participation in clinical research trial within 30 days prior to randomization&#xD;
&#xD;
         18. Allergy or sensitivity to study ingredients or who do not consume fish products (i.e.&#xD;
             vegetarians)&#xD;
&#xD;
         19. Participants who were on a low protein diet&#xD;
&#xD;
         20. Cognitively impaired and/or unable to give informed consent&#xD;
&#xD;
         21. Any other condition which in the Investigator's opinion may adversely affect the&#xD;
             individual's ability to complete the study or its measures or which may pose&#xD;
             significant risk to the individual (e.g. cardiovascular, renal, lung, diabetes,&#xD;
             psychiatric illness, bleeding disorders, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tetyana Pelipyagina, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KGK Science Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KGK Science Inc</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Abnormalities</mesh_term>
    <mesh_term>Skin Manifestations</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04449159
org study id: 16ASHV
nct id: NCT04449159
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Cheek skin elasticity
time frame: 12 weeks from baseline
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.
measure: Underarm skin elasticity
time frame: 12 weeks from baseline
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.
measure: Cheek Skin hydration
time frame: 12 weeks from baseline
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.
measure: Nasolabial wrinkles
time frame: 12 weeks from baseliine
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.
measure: Skin quality using visual analogue scale (VAS) scores
time frame: 12 weeks from baseliine
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.
measure: Net Skin elasticity
time frame: Baseline, week 6 and week 12.
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
measure: Biological elasticity
time frame: Baseline, week 6 and week 12.
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
measure: Viscoelastic recovery (overall elasticity)
time frame: 12 weeks from baseliine
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.
measure: Systolic and diastolic blood pressure
time frame: Baseline, week 6 and week 12.
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.
measure: Heart rate
time frame: Baseline, week 6 and week 12.
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.
measure: Body weight
time frame: Baseline, week 6 and week 12.
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.
measure: Body mass index (BMI)
time frame: Baseline, week 6 and week 12.
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.
measure: Complete blood count (CBC)
time frame: Baseline, week 6 and week 12.
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.
measure: Aspartate transaminase (AST)
time frame: Baseline, week 6 and week 12.
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.
measure: Alanine transaminase (ALT)
time frame: Baseline, week 6 and week 12.
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.
measure: Bilirubin
time frame: Baseline, week 6 and week 12.
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.
measure: Sodium ion
time frame: Baseline, week 6 and week 12.
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.
measure: Potassium ion
time frame: Baseline, week 6 and week 12.
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.
measure: Chloride ion
time frame: Baseline, week 6 and week 12.
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.
measure: Creatinine
time frame: Baseline, week 6 and week 12.
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.
measure: eGFR
time frame: Baseline, week 6 and week 12.
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.
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: Vinh Wellness Collagen
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Vinh Wellness Collagen
description: Vinh Wellness Collagen is hydrolyzed collagen
arm group label: Vinh Wellness Collagen
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tetyana Pelipyagina, MD
role: Principal Investigator
affiliation: KGK Science Inc.
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Skin Abnormalities
mesh term: Skin Manifestations
sharing ipd: No