The Effect of 12-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density and Other Skin Parameters

Not Applicable

Completed

• Conditions: Wrinkles; Dermis Density; Skin Hydration; Dermis Thickness; Skin Elasticity; Skin Texture; Trans Epidermal Water Loss (TEWL)
• Interventions: Dietary Supplement: Placebo syrup; Dietary Supplement: Investigational product 3; Dietary Supplement: Investigational product 1; Dietary Supplement: Investigational product 2

• Registration Number: NCT04988412
• Lead Sponsor: VIST - Faculty of Applied Sciences

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.

Study Timeline

• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-03
• Study Start: 2021-10-11
• Primary Completion: 2022-02-21
• Study Completion: 2022-04-21
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 109

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo syrup	Placebo group participants will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 0 mg, vitamin C: 0 mg); continous administration of placebo product for 12 weeks.
CoMSM HD	Investigational product 3	Participants will receive investigational product 3 containing collagen (10 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL).
CoMSM LD	Investigational product 1	Participants will receive investigational product 1 containing collagen (5 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL).
Co HD	Investigational product 2	Participants will receive investigational product 2 containing collagen (10 g/ 25 mL) and vitamin C (80 mg/ 25 mL).

Primary Outcome Measures

Name	Time	Method
Change of dermis density from baseline in all test groups in comparison to placebo group after 12 weeks of dietary supplementation	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 Outcome Measures

Name	Time	Method
Change of skin texture from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation	12 weeks	For assessments of skin texture topography roughness measurements (Ra, Rq) will be performed. Significant changes from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation is expected. Differences between test groups will also be evaluated.
Change of skin hydration from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation	12 weeks	Assessment of the effects of the investigational product on skin hydration after 12 weeks of dietary supplementation. Skin hydration measurements will be performed using conductance principle. Differences between test groups will also be evaluated.
Change of dermis thickness from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation	12 weeks	Significant change of dermis thickness from baseline in test group, in comparison to placebo group after 12 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 wrinkle volume from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation	12 weeks	Assessment of the effects of investigational product on periorbital wrinkles after 12 weeks of dietary supplementation will be done using topography measurements. Differences between test groups will also be evaluated.
Change of TEWL from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation	12 weeks	Assessment of the effects of investigational product on transepidermal water loss (TEWL) after 12 weeks of dietary supplementation. TEWL measurements will be performed using open chamber principle.Differences between test groups will also be evaluated.
Change of skin elasticity from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation	12 weeks	For assessments of elasticity viscoelasticity measurements will be performed. Significant changes from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation is expected. Differences between test groups will also be evaluated. Along viscoelasticity the measurement sinchronosusly gives also retraction and Young modulus values, as well as U-values: Uf (final deformation), Ue (skin exstensibility), Uv (delayed distension), Ur (immediate retraction), Ua (total recovery). R5 (Ur/Ue) parameter will also be calculated.

Trial Locations

Locations (1)

Higher School of Applied Sciences, Institute of Cosmetics; 🇸🇮 Ljubljana, Slovenia