Status:
COMPLETED
The Effect of 12-week Dietary Intake of Syrup Containing CoQ10 and Collagen on Dermis Density and Other Skin Parameters
Lead Sponsor:
VIST - Faculty of Applied Sciences
Collaborating Sponsors:
European Regional Development Fund
Valens Int. d.o.o., Slovenija
Conditions:
Dermis Density
Trans Epidermal Water Loss (TEWL)
Eligibility:
FEMALE
40-65 years
Phase:
NA
Brief 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 rece...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03811756
Start Date
October 15 2018
End Date
July 10 2019
Last Update
October 14 2021
Active Locations (1)
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1
Higher School of Applied Sciences, Institute of Cosmetics
Ljubljana, Slovenia, 1000