NCT05730517

The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density and Other Skin Parameters

The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density and Other Skin Parameters: Double Blind, Placebo-controlled, Randomised Three-way Study Comparing the Efficacy of Two Test Products

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: VIST - Faculty of Applied Sciences · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Single centre, randomized, double-blind, placebo-controlled, one-period effectiveness study will include 84 subjects. Subjects will be divided in three groups, 28 in each. Test group 1 (TG1) will receive investigational product 1 (CP5HA, daily dose 15 mL: collagen 5 g, hyaluronic acid (HA): 30 mg, vitamin C: 80 mg), test group 2 (TG2) will receive investigational product 2 (CP5, daily dose 15 mL: collagen 5 g, vitamin C: 80 mg) and the placebo group (PG) will receive placebo product without those active ingredients (15 mL: 0 g collagen, 0 g HA, 0 g vitamin C). Participants will test continuous administration of placebo or investigational products for 16 weeks in order to demonstrate and assess multiple-dose effects.

Conditions

• Dermis Density
• Wrinkles
• Skin Hydration
• Dermis Thickness
• Skin Texture
• Skin Elasticity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-13
• Primary completion: 2023-07-30
• Completion: 2023-10-10
• First posted: 2023-02-16
• Last updated: 2023-12-11

Locations

1 site across 1 country: Slovenia