NCT06755892

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

The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density and Other Skin Parameters: Double Blind, Placebo-controlled, Randomised Five-way Study Comparing the Efficacy of Four Test Products

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: VIST - Faculty of Applied Sciences · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dermis Density
• Wrinkles
• Dermis Thickness
• Skin Texture
• Skin Elasticity
• Skin Redness

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ColMSM-HL	Participants will test continuous administration of investigational product for 16 weeks.
DIETARY_SUPPLEMENT	Placebo syrup	Participants will test continuous administration of placebo product for 16 weeks.
DIETARY_SUPPLEMENT	ColMSM-LH	Participants will test continuous administration of investigational product for 16 weeks.
DIETARY_SUPPLEMENT	ColMSM-LL	Participants will test continuous administration of investigational product for 16 weeks.
DIETARY_SUPPLEMENT	Col-L	Participants will test continuous administration of investigational product for 16 weeks.

Timeline

• Start date: 2025-01-27
• Primary completion: 2025-06-17
• Completion: 2025-06-17
• First posted: 2025-01-01
• Last updated: 2025-10-02

Locations

1 site across 1 country: Slovenia