The Effect of 12-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density and Other Skin Parameters: Double Blind, Placebo-controlled, Randomised Four-way Study Comparing the Efficacy of Three Test Products
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dermis Density
- Sponsor
- VIST - Faculty of Applied Sciences
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Change of dermis density from baseline in all test groups in comparison to placebo group after 12 weeks of dietary supplementation
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The aim of the randomized, double-blind, placebo-controlled, one-period effectiveness study is to compare the effects of multiple-dose 12 weeks daily dietary supplementation with 10 g collagen alone or 5 g or 10 g of collagen in combination with MSM 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
This is a double-blind, randomized, placebo-controlled four-way study comparing the efficacy of multiple-dose dietary intake of three test products on skin parameters, that will be conducted in Slovenia in one research center. The study will be performed on 109 adult women, between the ages 40 and 65 years and will include daily dietary supplementation over 12-weeks period. Subjects will be divided in four study groups . Test group 1 (TG1) will receive investigational product 1 (IP1, daily dose 25 mL: collagen 5 g, MSM: 1,5 g, vitamin C: 80 mg), test group 2 (TG2) will receive investigational product 2 (IP2, daily dose 25 mL: collagen 10 g, vitamin C: 80 mg), test group 3 (TG3) will receive investigational product 3 (TP3, daily dose 25 mL: collagen 10 g, MSM: 1,5 g, , vitamin C: 80 mg) and the placebo group (PG) 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 12 weeks in order to demonstrate and assess multiple-dose effects. Their influence on skin appendages via self-evaluations questionnaires will also be assessed.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change of dermis density from baseline in all test groups in comparison to placebo group after 12 weeks of dietary supplementation
Time Frame: 12 weeks
Significant change of dermis density from baseline in test groups, in comparison to placebo group after 12 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 Outcomes
- Change of skin texture from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation(12 weeks)
- Change of skin hydration from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation(12 weeks)
- Change of dermis thickness from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation(12 weeks)
- Change of wrinkle volume from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation(12 weeks)
- Change of TEWL from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation(12 weeks)
- Change of skin elasticity from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation(12 weeks)