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

NCT ID: NCT04988412

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-11
• Study Completion Date: 2022-04-21

Brief 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.

Detailed Description

This is a double-blind, randomized, placebo-controlled four-way study comparing the efficacy of multiple-dose dietary intake of three test products on skin parameters, that will be conducted in Slovenia in one research center.

The study will be performed on 109 adult women, between the ages 40 and 65 years and will include daily dietary supplementation over 12-weeks period.

Subjects will be divided in four study groups . Test group 1 (TG1) will receive investigational product 1 (IP1, daily dose 25 mL: collagen 5 g, MSM: 1,5 g, vitamin C: 80 mg), test group 2 (TG2) will receive investigational product 2 (IP2, daily dose 25 mL: collagen 10 g, vitamin C: 80 mg), test group 3 (TG3) will receive investigational product 3 (TP3, daily dose 25 mL: collagen 10 g, MSM: 1,5 g, , vitamin C: 80 mg) and the placebo group (PG) will receive placebo product without those active ingredients (25 mL: 0 g collagen, 0 g MSM). Participants will test continuous administration of placebo or investigational products for 12 weeks in order to demonstrate and assess multiple-dose effects. Their influence on skin appendages via self-evaluations questionnaires will also be assessed.

Conditions

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

Study Design

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

Study Groups

CoMSM LD

Participants will receive investigational product 1 containing collagen (5 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL).

Group Type: ACTIVE_COMPARATOR

Investigational product 1

Intervention Type: DIETARY_SUPPLEMENT

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.

Placebo group

Placebo group participants will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 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 12 weeks.

Co HD

Participants will receive investigational product 2 containing collagen (10 g/ 25 mL) and vitamin C (80 mg/ 25 mL).

Group Type: ACTIVE_COMPARATOR

Investigational product 2

Intervention Type: DIETARY_SUPPLEMENT

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.

CoMSM HD

Participants will receive investigational product 3 containing collagen (10 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL).

Group Type: ACTIVE_COMPARATOR

Investigational product 3

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

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 12 weeks.

Intervention Type: 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.

Intervention Type: 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.

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 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, laser therapy etc.) in the last 4 months prior to study entry,
• Non-invasive rejuvenation treatments (e.g. radiofrequency, electrotherapy, ultrasound, intense pulsed light therapy (IPL)) 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

Higher School of Applied Sciences, Institute of Cosmetics

Ljubljana, , Slovenia

Countries

Slovenia

Other Identifiers

VIST TO-COSKIN 01-2021

Identifier Type: -

Identifier Source: org_study_id