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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
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.
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.
Age
40 - 65 years
Sex
FEMALE
Healthy Volunteers
Yes
Higher School of Applied Sciences, Institute of Cosmetics
Ljubljana, Slovenia
Start Date
October 11, 2021
Primary Completion Date
February 21, 2022
Completion Date
April 21, 2022
Last Updated
February 2, 2023
109
ACTUAL participants
Investigational product 1
DIETARY_SUPPLEMENT
Placebo syrup
DIETARY_SUPPLEMENT
Investigational product 2
DIETARY_SUPPLEMENT
Investigational product 3
DIETARY_SUPPLEMENT
Lead Sponsor
VIST - Faculty of Applied Sciences
Collaborators
NCT07255261
NCT07222397
Data Source & Attribution
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