The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density and Other Skin Parameters

Single centre, randomized, double-blind, placebo-controlled, one-period effectiveness study will include 84 subjects. Subjects will be divided in three groups, 28 in each. Test group 1 (TG1) will receive investigational product 1 (CP5HA, daily dose 15 mL: collagen 5 g, hyaluronic acid (HA): 30 mg, vitamin C: 80 mg), test group 2 (TG2) will receive investigational product 2 (CP5, daily dose 15 mL: collagen 5 g, vitamin C: 80 mg) and the placebo group (PG) will receive placebo product without those active ingredients (15 mL: 0 g collagen, 0 g HA, 0 g vitamin C). Participants will test continuous administration of placebo or investigational products for 16 weeks in order to demonstrate and assess multiple-dose effects.

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 clinically significant history of serious metabolic disease, digestive tract disease, liver disease, kidney disease, hematological disease,
• Intake of drugs with any impact on skin reactions (e.g., glucocorticoids, antihistamines, and immunomodulators),
• Any clinically significant acute or chronic skin diseases,
• Skin pigmentation disorders on measuring sites,
• Anticipated sunbathing or solarium visits before or during the study,
• Invasive rejuvenation treatments (e.g. needle rollers, needle mesotherapy, deep/medium-deep chemical peels, abrasive laser treatments etc.) in the last 4 months prior to study entry,
• Non-invasive rejuvenation treatments (e.g. radiofrequency, electrotherapy, ultrasound, intense pulsed light therapy (IPL), non-abrasive laser treatments) in the last month prior to study entry,
• Shaving/depilation of the arms in the last 14 days before inclusion,
• Mental incapacity that precludes adequate understanding or cooperation.