Efficacy Study of Oral Collagen Peptide on Skin Condition Improvement

NCT ID: NCT06847035

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2024-11-19

Brief Summary

To assess if oral intake of collagen peptide can improve skin conditions such as skin thickness, density and firmness.

Detailed Description

This is an one site, randomized, double-blind controlled clinical trial to assess the oral supplement of LISAVEI collagen peptide solid beverage on skin ageing improvement. Study product with collagen peptide and placebo product without collagen were randomly assigned to 90 eligible participants enrolled according to the inclusion and exclusion criteria. They took the assigned product once daily dissolved in 100 ml warm water for 12 weeks with 4-week regression phase(without intake of the test products), and visit the study site in Shanghai for four times(before starting the treatment, after 8 and 12 weeks, and 4 weeks after the last intake). Skin measurements including skin firmness, skin density, skin hydration and skin barrier were carried out at each visit with professional equipment and imaging system. Data were analyzed to validate if the administration of the test collagen peptide solid beverage will improve skin aging parameters such as firmness, thickness, density, hydration and skin barrier compared to placebo. The lasting effect was also observed by comparing between the two groups after 4-week regression time.

Conditions

Skin Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Comparator

collagen peptide solid beverage

Group Type: ACTIVE_COMPARATOR

Active Comparator

Intervention Type: DIETARY_SUPPLEMENT

LISAVEI collagen peptide solid beverage ( contain 5 g collagen peptide)，once daily for 12 weeks

Placebo Comaprator

placebo solid beverage

Group Type: PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type: DIETARY_SUPPLEMENT

placebo solid beverage (Maltodextrin with edible flavor)，once daily for 12 weeks

Interventions

Active Comparator

LISAVEI collagen peptide solid beverage ( contain 5 g collagen peptide)，once daily for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo Comparator

placebo solid beverage (Maltodextrin with edible flavor)，once daily for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

placebo solid beverage

Eligibility Criteria

Inclusion Criteria

1. Healthy female adults aged between 35-55 years old

2. With fine wrinkles and skin laxity

3. Personal informed consents to participate in the study

4. Agree to keep their daily skincare routine unchanged for the duration of the study

5. Maintain good sun protection habits

5. Agree to refrain from wearing make-up on the face on the each study visit

Exclusion Criteria

1. Female who is pregnant or nursing or planning to become pregnant during the course of the study

2. Individuals who are in the perimenopausal stage.

3. BMI<18.5 or BMI >27.9

4. Individuals suffering from chronic systemic diseases such as cardiovascular, cerebrovascular, liver, and kidney diseases.

5. Individuals who have diabetes.

6. Individuals suffering from skin conditions such as psoriasis, eczema, atopic dermatitis, and severe acne.

7. Individuals with depression or sleep disorders, those who smoke, and those who abuse alcohol.

8. Individuals who are using hormonal drugs, medications for obesity, absorption inhibitors, antidepressants, or appetite suppressants.

9. Individuals who have used hormones or anti-inflammatory drugs on their face and upper arms within the past two months.

10. Individuals who received facial laser therapy, chemical peeling or UV overexposure in the past 3 months

11. Individuals who can not avoid prolonged exposure to sunlight.

12. Individuals who are currently participating in other clinical studies or trials.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Meifute Biotechnology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Fumei Dermatology Clinic

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

YKEC-2024-001

Identifier Type: -

Identifier Source: org_study_id