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

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.

Conditions

• Dermis Density
• Wrinkles
• Skin Hydration
• Trans Epidermal Water Loss (TEWL)
• Dermis Thickness
• Skin Texture
• Skin Elasticity

Interventions

DIETARY_SUPPLEMENT

Investigational product 1

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.

DIETARY_SUPPLEMENT

Placebo syrup

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.

DIETARY_SUPPLEMENT

Investigational product 2

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.

DIETARY_SUPPLEMENT

Investigational product 3

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.

Sponsors & Collaborators

• Tosla d.o.o.

  collaborator INDUSTRY

• Slovenian Research Agency

  collaborator OTHER

• VIST - Faculty of Applied Sciences

  lead OTHER

Principal Investigators

• Katja Žmitek, PhD · Head of Reasearch Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-11

Primary Completion

2022-02-21

Completion

2022-04-21

Countries

• Slovenia

Study Locations