The Effect of 12-week Dietary Intake of Syrup Containing CoQ10 and Collagen on Dermis Density and Other Skin Parameters
NCT ID: NCT03811756
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2018-10-15
2019-07-10
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Test group
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).
Test syrup containing CoQ10 and collagen
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.
Placebo group
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.
Placebo syrup
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.
Interventions
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Test syrup containing CoQ10 and collagen
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.
Placebo syrup
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.
Eligibility Criteria
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Inclusion Criteria
* Signed Informed consent form (ICF),
* Fitzpatrick skin phototypes II and III,
* Signs of skin aging,
* In good health condition,
* Willingness to avoid a consumption of any food supplements containing CoQ10 and other antioxidants, collagen or vitamins during the study,
* Willingness to follow all study procedures and keeping a diary during the study (to follow their compliance and palatability).
Exclusion Criteria
* Known or suspected allergy to any ingredient of the tested products,
* Changes in dietary habits and dietary supplementation in last three months prior to inclusion,
* Regular use of food supplements containing CoQ10 or other antioxidants, collagen or other protein-based food supplements, vitamin A, vitamin E or biotin in last three months prior to inclusion,
* Veganism,
* Changes in cosmetic facial and body care routine in last month prior to inclusion,
* Diagnosed and uncontrolled/untreated/unregulated disease,
* Any clinically significant history of serious metabolic disease, digestive tract disease, liver disease, kidney disease, haematological disease,
* Acute skin diseases,
* Skin pigmentation disorders,
* Increased cholesterol and use of cholesterol lowering drugs (statins),
* Anticipated sunbathing or solarium visits before or during the study,
* Invasive rejuvenation treatments (e.g. needle rollers, needle mesotherapy, deep/medium-deep chemical peels etc.) in last 6 months prior to study entry,
* Non-invasive rejuvenation treatments (e.g. radiofrequency, electrotherapy, ultrasound therapy) in last 2 months prior to study entry,
* Mental incapacity that precludes adequate understanding or cooperation.
40 Years
65 Years
FEMALE
Yes
Sponsors
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European Regional Development Fund
OTHER
Valens Int. d.o.o., Slovenija
INDUSTRY
Ministry of Education, Science and Sport, Republic of Slovenia
UNKNOWN
VIST - Faculty of Applied Sciences
OTHER
Responsible Party
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Principal Investigators
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Katja Žmitek, PhD
Role: STUDY_DIRECTOR
Head of Reasearch Group
Locations
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Higher School of Applied Sciences, Institute of Cosmetics
Ljubljana, , Slovenia
Countries
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Other Identifiers
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VIST F4F Q10-collagen 01-2018
Identifier Type: -
Identifier Source: org_study_id