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

NCT04988412 | Completed

• 1 other identifier: VIST TO-COSKIN 01-2021
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change of dermis density from baseline in all test groups in comparison to placebo group after 12 weeks of dietary supplementation

  Significant change of dermis density from baseline in test groups, in comparison to placebo group after 12 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.

  12 weeks

Secondary Outcomes (6)

• Change of wrinkle volume from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation

  12 weeks

• Change of skin texture from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation

  12 weeks

• Change of skin hydration from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation

  12 weeks

• Change of TEWL from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation

  12 weeks

• Change of dermis thickness from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation

  12 weeks

Study Arms (4)

CoMSM LD

ACTIVE COMPARATOR

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).

Dietary Supplement: Investigational product 1

Placebo group

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo syrup

Co HD

ACTIVE COMPARATOR

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

Dietary Supplement: Investigational product 2

CoMSM HD

ACTIVE COMPARATOR

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).

Dietary Supplement: Investigational product 3

Interventions

Investigational product 1 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.

CoMSM LD

Placebo syrup 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.

Placebo group

Investigational product 2 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.

Co HD

Investigational product 3 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.

CoMSM HD

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,
• 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.

You may not qualify if:

• Pregnancy or breastfeeding,
• Known or suspected allergy to any ingredient of the tested products,
• Veganism,
• 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,
• Mental incapacity that precludes adequate understanding or cooperation.

Sponsors & Collaborators

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

Study Sites (1)

Higher School of Applied Sciences, Institute of Cosmetics

Ljubljana, 1000, Slovenia

Location

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: July 28, 2021
• First Posted: August 3, 2021
• Study Start: October 11, 2021
• Primary Completion: February 21, 2022
• Study Completion: April 21, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)