The Effect of 16-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 16 weeks daily dietary supplementation with 5 g collagen alone or 5 g of collagen in combination with hyaluronic acid 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
• Dermis Thickness
• Skin Texture
• Skin Elasticity

Interventions

DIETARY_SUPPLEMENT

CP5HA

Test group 1 will receive investigational product 1 containing collagen (5 g/ 15 mL), hyaluronic acid (30 mg/ 15 mL) and vitamin C (80 mg/ 15 mL); continuous administration of investigational product for 16 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 16 weeks.

DIETARY_SUPPLEMENT

CP5

Test group 2 will receive investigational product 2 containing collagen (5 g/ 15 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 16 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

2023-02-13

Primary Completion

2023-07-30

Completion

2023-10-10

Countries

• Slovenia

Study Locations