The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen and MSM on Skin

Not Applicable

Active, not recruiting

• Conditions: Dermis Density; Wrinkles; Dermis Thickness; Skin Texture; Skin Elasticity; Skin Redness

• Registration Number: NCT06755892
• Lead Sponsor: VIST - Faculty of Applied Sciences

Brief Summary

The aim of the study is to compare the effects of multiple-dose 16 weeks daily dietary supplementation with 5 g or 3 g of collagen in combination with 1 g or 1.5 g of MSM and 80 mg vitamin C (see 1.2. Investigational and placebo product profile) 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.

Detailed Description

Single centre, randomized, double-blind, placebo-controlled, one-period effectiveness study will include 135 subjects. Subjects will be divided in five groups, 27 in each. Test group 1 (IP1 group) will receive investigational product 1 (IP1, daily dose 25 mL: collagen 5 g, MSM: 1,0 g, vitamin C: 80 mg), test group 2 (IP2 group) will receive investigational product 2 (IP2, daily dose 25 mL: collagen 3 g, MSM: 1,5 g, vitamin C: 80 mg), test group 3 (IP3 group) will receive investigational product 3 (IP3, daily dose 25 mL: collagen 3 g, MSM: 1,0 g, vitamin C: 80 mg), test group 4 (IP4 group will receive investigational product 4 (IP4, daily dose 25 mL: collagen 3 g, vitamin C: 80 mg) and the placebo group will receive placebo product without those active ingredients (25 mL: 0 g collagen, 0 g MSM). Participants will test continuous administration of placebo or investigational products for 16 weeks to demonstrate and assess multiple-dose effects.

Study Timeline

• Study First Submitted: 2024-12-24
• Study First Submitted QC: 2024-12-24
• Study First Posted: 2025-01-01
• Study Start: 2025-01-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-08-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 135

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of dermis density from baseline in all test groups in comparison to placebo group after 16 weeks of dietary supplementation	16 weeks	Significant change of dermis density from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation with study product is expected. Dermis density will be assessed through ultrasonographic dermis intensity measurement. Differences in change of dermis density between test groups under primary objective conditions will also be evaluated.

Secondary Outcome Measures

Name	Time	Method
Change of wrinkle volume from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation	16 weeks	Assessment of the effects of investigational product on periorbital wrinkles after 16 weeks of dietary supplementation will be done using topography measurements. Differences between test groups will also be evaluated.
Change of skin texture from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation	16 weeks	For assessments of skin texture topography roughness measurements (Ra) will be performed. Significant changes from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation is expected. Differences between test groups will also be evaluated.
Change of skin redness from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation	16 weeks	Assessment of the effects of the investigational product on skin redness after 16 weeks of dietary supplementation. Skin redness (redness score, variation and uniformity) will be measured using Antera 3D CS. Differences between test groups will also be evaluated.
Change of dermis thickness from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation	12 weeks	Significant change of dermis thickness from baseline in test group, in comparison to placebo group after 16 weeks of dietary supplementation with study product is expected. Dermis density will be assessed using ultrasonography. Differences between test groups will also be evaluated.
Change of skin elasticity from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation	16 weeks	Elasticity measurements will be performed. Significant changes from baseline in test groups in comparison to the placebo group after 16 weeks of dietary supplementation are expected. Differences between test groups will also be evaluated.

Trial Locations

Locations (1)

VIST - Faculty of Applied Sciences, Institute of Cosmetics; 🇸🇮 Ljubljana, Slovenia