CompletedNot Applicable

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

Slovenia34 participantsStarted 2018-10-15

Plain-language summary

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.

Who can participate

Age range

40 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement

Timeframe: 12 weeks

Trial details

NCT IDNCT03811756

SponsorVIST - Faculty of Applied Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02-19

View on ClinicalTrials.gov More Dermis Density trials