NCT05730517

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

February 13, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

January 31, 2023

Last Update Submit

December 8, 2023

Conditions

Dermis DensityWrinklesSkin HydrationDermis ThicknessSkin TextureSkin Elasticity

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 hydration 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

    16 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 (3)

Test group 1 (CP5HA Group)

ACTIVE COMPARATOR

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).

Dietary Supplement: CP5HA

Placebo group

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo syrup

Test group 2 (CP5 Group)

ACTIVE COMPARATOR

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

Dietary Supplement: CP5

Interventions

CP5HADIETARY_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.

Test group 1 (CP5HA Group)
Placebo syrupDIETARY_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.

Placebo group
CP5DIETARY_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.

Test group 2 (CP5 Group)

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (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 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.

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, 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,
  • Mental incapacity that precludes adequate understanding or cooperation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VIST - Faculty 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

January 31, 2023

First Posted

February 16, 2023

Study Start

February 13, 2023

Primary Completion

July 30, 2023

Study Completion

October 10, 2023

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)