<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/NCT03811756</url>
  </required_header>
  <id_info>
    <org_study_id>VIST F4F Q10-collagen 01-2018</org_study_id>
    <nct_id>NCT03811756</nct_id>
  </id_info>
  <brief_title>The Effect of 12-week Dietary Intake of Syrup Containing CoQ10 and Collagen on Dermis Density and Other Skin Parameters</brief_title>
  <acronym>Q10-collagen</acronym>
  <official_title>The Effect of 12-week Dietary Intake of Syrup Containing CoQ10 and Collagen on Dermis Density and Other Skin Parameters: Randomised Double-blind Placebo-controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VIST - Faculty of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Regional Development Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Valens Int. d.o.o., Slovenija</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Education, Science and Sport, Republic of Slovenia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VIST - Faculty of Applied Sciences</source>
  <oversight_info>
    <has_dmc>No</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>
      Placebo controlled double-blind multi-dose comparative study of the effects of coenzyme Q10&#xD;
      and collagen formulation with improved water-solubility in healthy adults.&#xD;
&#xD;
      One group (test group) will receive investigational product - test syrup (daily dose 10 mL:&#xD;
      fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A:&#xD;
      920 μg, biotin: 150 μg) and the other (placebo group) placebo syrup without those active&#xD;
      ingredients. Participants will test continuous administration of placebo or investigational&#xD;
      product for 12 weeks in order to demonstrate and assess multiple-dose effects on skin&#xD;
      condition and signs of skin aging.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2018</start_date>
  <completion_date type="Actual">July 10, 2019</completion_date>
  <primary_completion_date type="Actual">February 19, 2019</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>Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement</measure>
    <time_frame>12 weeks</time_frame>
    <description>Significant change of dermis density from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Dermis density will be assessed through ultrasonographic dermis intensity measurement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity</measure>
    <time_frame>12 weeks</time_frame>
    <description>For assessments of skin viscoelasticity measurements will be performed. Significant change of skin viscoeasticity from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of the investigational product in relation to placebo product on skin hydration</measure>
    <time_frame>12 weeks</time_frame>
    <description>Assessment of the effects of the investigational product on skin hydration after 12 weeks of dietary supplementation. Skin hydration measurements will be performed using conductance principle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of the investigational product in relation to placebo product on TEWL</measure>
    <time_frame>12 weeks</time_frame>
    <description>Assessment of the effects of investigational product on transepidermal water loss after 12 weeks of dietary supplementation. TEWL measurements will be performed using open chambre principle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of investigational product in relation to placebo product on dermis thickness</measure>
    <time_frame>12 weeks</time_frame>
    <description>Significant change of dermis thickness from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Dermis density will be assessed using ultrasonography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of investigational product in relation to placebo product on wrinkles will be assessed using wrinkle area fraction measurements</measure>
    <time_frame>12 weeks</time_frame>
    <description>Assessment of the effects of investigational product on facial wrinkles after 12 weeks of dietary supplementation will be done using wrinkle area fraction measurements.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Dermis Density</condition>
  <condition>Trans Epidermal Water Loss (TEWL)</condition>
  <condition>Skin Hydration</condition>
  <condition>Wrinkles</condition>
  <condition>Dermis Thickness</condition>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive investigational product - Test syrup containing CoQ10 and collagen (daily dose 10 mL: fish collagen (Peptan®): 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo group participants will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 0 mg, water soluble CoQ10 (Q10Vital®): 0 mg, vitamin C: 0 mg, vitamin A: 0 μg, biotin: 0 μg); continous administration of placebo product for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Test syrup containing CoQ10 and collagen</intervention_name>
    <description>Test group will receive investigational product - test syrup (daily dose 10 mL: fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg); continuous administration of investigational product for 12 weeks.</description>
    <arm_group_label>Test group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo syrup</intervention_name>
    <description>Placebo group will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 0 mg, water soluble CoQ10 (Q10Vital®): 0 mg, vitamin C: 0 mg, vitamin A: 0 μg, biotin: 0 μg); continous administration of placebo product for 12 weeks.</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caucasian female volunteers aged between 40 and 65 years at the time of the signature&#xD;
             of Informed consent form (ICF),&#xD;
&#xD;
          -  Signed Informed consent form (ICF),&#xD;
&#xD;
          -  Fitzpatrick skin phototypes II and III,&#xD;
&#xD;
          -  Signs of skin aging,&#xD;
&#xD;
          -  In good health condition,&#xD;
&#xD;
          -  Willingness to avoid a consumption of any food supplements containing CoQ10 and other&#xD;
             antioxidants, collagen or vitamins during the study,&#xD;
&#xD;
          -  Willingness to follow all study procedures and keeping a diary during the study (to&#xD;
             follow their compliance and palatability).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or breastfeeding,&#xD;
&#xD;
          -  Known or suspected allergy to any ingredient of the tested products,&#xD;
&#xD;
          -  Changes in dietary habits and dietary supplementation in last three months prior to&#xD;
             inclusion,&#xD;
&#xD;
          -  Regular use of food supplements containing CoQ10 or other antioxidants, collagen or&#xD;
             other protein-based food supplements, vitamin A, vitamin E or biotin in last three&#xD;
             months prior to inclusion,&#xD;
&#xD;
          -  Veganism,&#xD;
&#xD;
          -  Changes in cosmetic facial and body care routine in last month prior to inclusion,&#xD;
&#xD;
          -  Diagnosed and uncontrolled/untreated/unregulated disease,&#xD;
&#xD;
          -  Any clinically significant history of serious metabolic disease, digestive tract&#xD;
             disease, liver disease, kidney disease, haematological disease,&#xD;
&#xD;
          -  Acute skin diseases,&#xD;
&#xD;
          -  Skin pigmentation disorders,&#xD;
&#xD;
          -  Increased cholesterol and use of cholesterol lowering drugs (statins),&#xD;
&#xD;
          -  Anticipated sunbathing or solarium visits before or during the study,&#xD;
&#xD;
          -  Invasive rejuvenation treatments (e.g. needle rollers, needle mesotherapy,&#xD;
             deep/medium-deep chemical peels etc.) in last 6 months prior to study entry,&#xD;
&#xD;
          -  Non-invasive rejuvenation treatments (e.g. radiofrequency, electrotherapy, ultrasound&#xD;
             therapy) in last 2 months prior to study entry,&#xD;
&#xD;
          -  Mental incapacity that precludes adequate understanding or cooperation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katja Žmitek, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Head of Reasearch Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Higher School of Applied Sciences, Institute of Cosmetics</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>October 5, 2021</last_update_submitted>
  <last_update_submitted_qc>October 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coenzyme Q10</mesh_term>
  </intervention_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/NCT03811756
org study id: VIST F4F Q10-collagen 01-2018
nct id: NCT03811756
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Placebo controlled double-blind multi-dose comparative study of the effects of coenzyme Q10
      and collagen formulation with improved water-solubility in healthy adults.

      One group (test group) will receive investigational product - test syrup (daily dose 10 mL:
      fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A:
      920 μg, biotin: 150 μg) and the other (placebo group) placebo syrup without those active
      ingredients. Participants will test continuous administration of placebo or investigational
      product for 12 weeks in order to demonstrate and assess multiple-dose effects on skin
      condition and signs of skin aging.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement
time frame: 12 weeks
description: Significant change of dermis density from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Dermis density will be assessed through ultrasonographic dermis intensity measurement.
measure: Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity
time frame: 12 weeks
description: For assessments of skin viscoelasticity measurements will be performed. Significant change of skin viscoeasticity from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected.
measure: Influence of the investigational product in relation to placebo product on skin hydration
time frame: 12 weeks
description: Assessment of the effects of the investigational product on skin hydration after 12 weeks of dietary supplementation. Skin hydration measurements will be performed using conductance principle.
measure: Influence of the investigational product in relation to placebo product on TEWL
time frame: 12 weeks
description: Assessment of the effects of investigational product on transepidermal water loss after 12 weeks of dietary supplementation. TEWL measurements will be performed using open chambre principle.
measure: Influence of investigational product in relation to placebo product on dermis thickness
time frame: 12 weeks
description: Significant change of dermis thickness from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Dermis density will be assessed using ultrasonography.
measure: Influence of investigational product in relation to placebo product on wrinkles will be assessed using wrinkle area fraction measurements
time frame: 12 weeks
description: Assessment of the effects of investigational product on facial wrinkles after 12 weeks of dietary supplementation will be done using wrinkle area fraction measurements.
arm group label: Test group
arm group type: Active Comparator
description: Participants will receive investigational product - Test syrup containing CoQ10 and collagen (daily dose 10 mL: fish collagen (Peptan®): 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg).
arm group label: Placebo group
arm group type: Placebo Comparator
description: Placebo group participants will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 0 mg, water soluble CoQ10 (Q10Vital®): 0 mg, vitamin C: 0 mg, vitamin A: 0 μg, biotin: 0 μg); continous administration of placebo product for 12 weeks.
intervention type: Dietary Supplement
intervention name: Test syrup containing CoQ10 and collagen
description: Test group will receive investigational product - test syrup (daily dose 10 mL: fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg); continuous administration of investigational product for 12 weeks.
arm group label: Test group
intervention type: Dietary Supplement
intervention name: Placebo syrup
description: Placebo group will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 0 mg, water soluble CoQ10 (Q10Vital®): 0 mg, vitamin C: 0 mg, vitamin A: 0 μg, biotin: 0 μg); continous administration of placebo product for 12 weeks.
arm group label: Placebo group
criteria: 
gender: Female
gender based: Yes
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Katja Žmitek, PhD
role: Study Director
affiliation: Head of Reasearch Group
facility: 
country: Slovenia
responsible party type: Sponsor
mesh term: Coenzyme Q10
sharing ipd: No