The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen and MSM on Skin

NCT06755892 | Completed

• 1 other identifier: VIST TO-COSKIN3 03-2024
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the effects of multiple-dose 16 weeks daily dietary supplementation with 5 g or 3 g of collagen in combination with 1 g or 1.5 g of MSM and 80 mg vitamin C (see 1.2. Investigational and placebo product profile) 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; Dermis Thickness; Skin Texture; Skin Elasticity; Skin Redness

Outcome Measures

Primary Outcomes (1)

• Change of dermis density from baseline in all test groups in comparison to placebo group after 16 weeks of dietary supplementation

  Significant change of dermis density from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation with study product is expected. Dermis density will be assessed through ultrasonographic dermis intensity measurement. Differences in change of dermis density between test groups under primary objective conditions will also be evaluated.

  16 weeks

Secondary Outcomes (5)

• Change of wrinkle volume from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation

  16 weeks

• Change of skin texture from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation

  16 weeks

• Change of skin redness from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation

  16 weeks

• Change of dermis thickness from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation

  12 weeks

• Change of skin elasticity from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation

  16 weeks

Study Arms (5)

IP1 group

ACTIVE COMPARATOR

Participants will receive investigational product 1 containing collagen (5 g/ 25 mL), MSM (1.0 g/ 25 mL) and vitamin C (80 mg/ 25 mL) for 16 weeks.

Dietary Supplement: ColMSM-HL

IP2 group

ACTIVE COMPARATOR

Participants will receive investigational product 2 containing collagen (3 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL), 25 mL/daily for 16 weeks.

Dietary Supplement: ColMSM-LH

IP3 group

ACTIVE COMPARATOR

Participants will receive investigational product 3 containing collagen (3 g/ 25 mL), MSM (1.0 g/ 25 mL) and vitamin C (80 mg/ 25 mL), 25 mL/daily for 16 weeks.

Dietary Supplement: ColMSM-LL

IP4 group

ACTIVE COMPARATOR

Participants will receive investigational product 4 containing containing collagen (3 g/ 25 mL) and vitamin C (80 mg/ 25 mL), 25 mL/daily for 16 weeks.

Dietary Supplement: Col-L

Placebo group

PLACEBO COMPARATOR

Placebo group participants will receive placebo syrup without active ingredients (0 mg of collagen, 0 mg of MSM and 0 mg of vitamin C), 25 mL/daily for 16 weeks.

Dietary Supplement: Placebo syrup

Interventions

ColMSM-HL DIETARY_SUPPLEMENT

Participants will test continuous administration of investigational product for 16 weeks.

Also known as: Investigational product 1

IP1 group

Placebo syrup DIETARY_SUPPLEMENT

Participants will test continuous administration of placebo product for 16 weeks.

Placebo group

ColMSM-LH DIETARY_SUPPLEMENT

Participants will test continuous administration of investigational product for 16 weeks.

Also known as: Investigational product 2

IP2 group

ColMSM-LL DIETARY_SUPPLEMENT

Participants will test continuous administration of investigational product for 16 weeks.

Also known as: Investigational product 3

IP3 group

Col-L DIETARY_SUPPLEMENT

Participants will test continuous administration of investigational product for 16 weeks.

Also known as: Investigational product 4

IP4 group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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 oestrogen 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.

You may not qualify if:

• Pregnancy or breastfeeding,
• Known or suspected allergy to any ingredient of the tested products,
• Veganism,
• Diagnosed and uncontrolled/untreated/unregulated disease,
• Any clinically significant history of serious metabolic disease, digestive tract disease, liver disease, kidney disease, haematological 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, IPL therapy) in the last month prior to study entry,
• Mental incapacity that precludes adequate understanding or cooperation.

Sponsors & Collaborators

• VIST - Faculty of Applied Sciences: lead
• Tosla d.o.o.: collaborator
• Slovenian Research and Innovation Agency: collaborator

Study Sites (1)

VIST - Faculty of Applied Sciences, Institute of Cosmetics

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katja Žmitek, PhD

  Head of Reasearch Group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 1, 2025
• Study Start: January 27, 2025
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)