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

NCT ID: NCT05730517

Last Updated: 2023-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-13
• Study Completion Date: 2023-10-10

Brief 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

Study Design

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

Study Groups

Test group 1 (CP5HA Group)

Participants will receive investigational product 1 containing collagen (5 g/ 15 mL), hyaluronic acid (30 mg/ 15 mL) and vitamin C (80 mg/ 15 mL).

Group Type: ACTIVE_COMPARATOR

CP5HA

Intervention Type: DIETARY_SUPPLEMENT

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.

Placebo group

Placebo group participants will receive placebo syrup without active ingredients. (daily dose 15 mL: collagen: 0 mg, HA: 0 mg, vitamin C: 0 mg); continous administration of placebo product for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo syrup

Intervention Type: DIETARY_SUPPLEMENT

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.

Test group 2 (CP5 Group)

Participants will receive investigational product 2 containing collagen (5 g/ 15 mL) and vitamin C (80 mg/ 15 mL).

Group Type: ACTIVE_COMPARATOR

CP5

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Caucasian female volunteers aged between 40 and 65 years at the time of the signature of Informed consent form (ICF),
• Signed Informed consent form (ICF),
• Fitzpatrick skin phototypes I-IV,
• Signs of skin aging,
• In good general health condition,
• Body mass index (BMI) < 35
• Willingness to avoid a consumption of any food supplements containing hyaluronic acid, methylsulfonylmethane (MSM), antioxidants, collagen and other protein-based food supplements during the study,
• Willingness to follow all study procedures and keeping a diary during the study (to follow their compliance and palatability).
• Willingness to maintain their living habits and to not begin or change any estrogen or progesterone therapies,
• Willingness to avoid shaving/depilation of their arms during the study,
• Willingness not to change cosmetic treatment routine during the study,
• Willingness to avoid rejuvenation treatments during the study.

Exclusion Criteria

• Pregnancy or breastfeeding,
• Known or suspected allergy to any ingredient of the tested products,
• Changes in dietary habits and dietary supplementation in the last three months prior to inclusion,
• Regular use of food supplements containing MSM, antioxidants, collagen or other protein-based food supplements in the last three months prior to inclusion,
• Veganism,
• Changes in cosmetic facial and body care routine in the last month prior to inclusion,
• Diagnosed and uncontrolled/unregulated disease,
• Any clinically significant history of serious metabolic disease, digestive tract disease, liver disease, kidney disease, hematological disease,
• Intake of drugs with any impact on skin reactions (e.g., glucocorticoids, antihistamines, and immunomodulators),
• Any clinically significant acute or chronic skin diseases,
• Skin pigmentation disorders on measuring sites,
• Anticipated sunbathing or solarium visits before or during the study,
• Invasive rejuvenation treatments (e.g. needle rollers, needle mesotherapy, deep/medium-deep chemical peels, abrasive laser treatments etc.) in the last 4 months prior to study entry,
• Non-invasive rejuvenation treatments (e.g. radiofrequency, electrotherapy, ultrasound, intense pulsed light therapy (IPL), non-abrasive laser treatments) in the last month prior to study entry,
• Shaving/depilation of the arms in the last 14 days before inclusion,
• Mental incapacity that precludes adequate understanding or cooperation.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tosla d.o.o.

INDUSTRY

Sponsor Role: collaborator

Slovenian Research Agency

OTHER

Sponsor Role: collaborator

VIST - Faculty of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katja Žmitek, PhD

Role: STUDY_DIRECTOR

Head of Reasearch Group

Locations

VIST - Faculty of Applied Sciences, Institute of Cosmetics

Ljubljana, , Slovenia

Countries

Slovenia

Other Identifiers

VIST TO-COSKIN-2 01-2023

Identifier Type: -

Identifier Source: org_study_id