The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density an… (NCT05730517) | Clinical Trial Compass
CompletedNot Applicable
The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density and Other Skin Parameters
Slovenia87 participantsStarted 2023-02-13
Plain-language summary
The aim of the randomized, double-blind, placebo-controlled, one-period effectiveness study is to compare the effects of multiple-dose 16 weeks daily dietary supplementation with 5 g collagen alone or 5 g of collagen in combination with hyaluronic acid on skin in healthy human subjects in comparison to placebo product. The main objective is to show that test products have beneficial effects on dermis density, and also on other skin parameters and to investigate differences in the effects among test products.
Who can participate
Age range40 Years – 65 Years
SexFEMALE
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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 I-IV,
* Signs of skin aging,
* In good general health condition,
* Body mass index (BMI) \< 35
* Willingness to avoid a consumption of any food supplements containing hyaluronic acid, methylsulfonylmethane (MSM), antioxidants, collagen and other protein-based food supplements during the study,
* Willingness to follow all study procedures and keeping a diary during the study (to follow their compliance and palatability).
* Willingness to maintain their living habits and to not begin or change any estrogen or progesterone therapies,
* Willingness to avoid shaving/depilation of their arms during the study,
* Willingness not to change cosmetic treatment routine during the study,
* Willingness to avoid rejuvenation treatments during the study.
Exclusion criteria:
* Pregnancy or breastfeeding,
* Known or suspected allergy to any ingredient of the tested products,
* Changes in dietary habits and dietary supplementation in the last three months prior to inclusion,
* Regular use of food supplements containing MSM, antioxidants, collagen or other protein-based food supplements in the last three months prior to inclusion,
* Veganism,
* Changes in cosmetic facial and body care routine in the last month prior to inclusion,
* Diagnosed and uncontrolled/unregulated disease,
* Any cli…
What they're measuring
1
Change of dermis density from baseline in all test groups in comparison to placebo group after 16 weeks of dietary supplementation