The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen and MSM on Skin (TO-COSKIN3)

October 1, 2025 updated by: VIST - Faculty of Applied Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Single centre, randomized, double-blind, placebo-controlled, one-period effectiveness study will include 135 subjects. Subjects will be divided in five groups, 27 in each. Test group 1 (IP1 group) will receive investigational product 1 (IP1, daily dose 25 mL: collagen 5 g, MSM: 1,0 g, vitamin C: 80 mg), test group 2 (IP2 group) will receive investigational product 2 (IP2, daily dose 25 mL: collagen 3 g, MSM: 1,5 g, vitamin C: 80 mg), test group 3 (IP3 group) will receive investigational product 3 (IP3, daily dose 25 mL: collagen 3 g, MSM: 1,0 g, vitamin C: 80 mg), test group 4 (IP4 group will receive investigational product 4 (IP4, daily dose 25 mL: collagen 3 g, vitamin C: 80 mg) and the placebo group 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 16 weeks to demonstrate and assess multiple-dose effects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • VIST - Faculty of Applied Sciences, Institute of Cosmetics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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,
  • 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.

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/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,
  • Shaving/depilation of the arms in the last 14 days before inclusion,
  • Mental incapacity that precludes adequate understanding or cooperation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: IP1 group
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
Participants will test continuous administration of investigational product for 16 weeks.
Other Names:
  • Investigational product 1
Active Comparator: IP2 group
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
Participants will test continuous administration of investigational product for 16 weeks.
Other Names:
  • Investigational product 2
Active Comparator: IP3 group
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
Participants will test continuous administration of investigational product for 16 weeks.
Other Names:
  • Investigational product 3
Placebo Comparator: Placebo group
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
Participants will test continuous administration of placebo product for 16 weeks.
Active Comparator: IP4 group
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
Participants will test continuous administration of investigational product for 16 weeks.
Other Names:
  • Investigational product 4

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of dermis density from baseline in all test groups in comparison to placebo group after 16 weeks of dietary supplementation
Time Frame: 16 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of wrinkle volume from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation
Time Frame: 16 weeks
Assessment of the effects of investigational product on periorbital wrinkles after 16 weeks of dietary supplementation will be done using topography measurements. Differences between test groups will also be evaluated.
16 weeks
Change of skin redness from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation
Time Frame: 16 weeks
Assessment of the effects of the investigational product on skin redness after 16 weeks of dietary supplementation. Skin redness (redness score, variation and uniformity) will be measured using Antera 3D CS. Differences between test groups will also be evaluated.
16 weeks
Change of dermis thickness from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation
Time Frame: 12 weeks
Significant change of dermis thickness from baseline in test group, in comparison to placebo group after 16 weeks of dietary supplementation with study product is expected. Dermis density will be assessed using ultrasonography. Differences between test groups will also be evaluated.
12 weeks
Change of skin texture from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation
Time Frame: 16 weeks
For assessments of skin texture topography roughness measurements (Ra) will be performed. Significant changes from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation is expected. Differences between test groups will also be evaluated.
16 weeks
Change of skin elasticity from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation
Time Frame: 16 weeks
Elasticity measurements will be performed. Significant changes from baseline in test groups in comparison to the placebo group after 16 weeks of dietary supplementation are expected. Differences between test groups will also be evaluated.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VIST - Faculty of Applied Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tosla d.o.o.
Slovenian Research and Innovation Agency

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Katja Žmitek, PhD, Head of Reasearch Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 1, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VIST TO-COSKIN3 03-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings