The Effect of 12-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density and Other Skin Parameters
Condition: Dermis Density; Wrinkles; Skin Hydration; Trans Epidermal Water Loss (TEWL); Dermis Thickness; Skin Texture; Skin Elasticity
Study type: Interventional

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.
    

Intervention name(s): Investigational product 1; Placebo syrup; Investigational product 2; Investigational product 3
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Test group 1 will receive investigational product 1 containing collagen (5 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 12 weeks.; Placebo group will receive placebo syrup without active ingredients. (daily dose 25 mL: collagen: 0 mg, MSM: 0 mg, vitamin C: 0 mg; continous administration of placebo product for 12 weeks.; Test group 2 will receive investigational product 2 containing collagen (10 g/ 25 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 12 weeks.; Test group 3 will receive investigational product 3 containing collagen (10 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment