The Effect of 12-week Dietary Intake of Syrup Containing CoQ10 and Collagen on Dermis Density and Other Skin Parameters (Q10-collagen)

VIST - Faculty of Applied Sciences

Status: Completed

Conditions: Wrinkles; Skin Hydration; Trans Epidermal Water Loss (TEWL); Dermis Thickness; Dermis Density

Treatments: Dietary Supplement: Placebo syrup; Dietary Supplement: Test syrup containing CoQ10 and collagen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03811756

VIST F4F Q10-collagen 01-2018

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Caucasian female volunteers aged between 40 and 65 years at the time of the signature of Informed consent form (ICF),
• 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

• Pregnancy or breastfeeding,
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

Test group

Active Comparator group

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).

Treatment:

Dietary Supplement: Test syrup containing CoQ10 and collagen

Placebo group

Placebo Comparator group

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.

Treatment:

Dietary Supplement: Placebo syrup