NCT06306105

Brief Summary

To assess the anti-aging efficacy of Marine Collagen Peptides on skin, hair and finger nails for human

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

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

Study Start

First participant enrolled

March 4, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

March 5, 2024

Last Update Submit

September 3, 2024

Conditions

Keywords

fish collagen

Outcome Measures

Primary Outcomes (13)

  • The change of skin hydation

    Corneometer® CM825 (CK, Germany) was utilized to measure skin surface hydation. Units: arbitrary Corneometer® units 0-120.

    Change from Baseline skin skin hydation at 12 weeks

  • The change of skin wrinkles

    VISIA Complexion Analysis was utilized to measure skin wrinkles. Units: the amount of detectable wrinkles

    Change from Baseline skin wrinkles at 12 weeks

  • The change of skin elasticity

    Cutometer® MPA580 was utilized to measure skin elasticity. Units: visco-elasticity in %.

    Change from Baseline skin elasticity at 12 weeks

  • The change of skin collagen density

    DermaLab® Series SkinLab Combo was utilized to measure skin collagen density. Units: arbitrary units

    Change from Baseline skin collagen density at 12 weeks

  • The change of hair diameters

    Mitutoyo C/N293-100 was utilized to measure hair diameters. Units: millimeter

    Change from Baseline hair diameters at 12 weeks

  • The change of hair loss amount

    Collect and measure the weight of loss hair. Units: gram

    Change from Baseline hair loss amount at 12 weeks

  • The change of hair roots diameters

    Mitutoyo C/N293-100 was utilized to measure hair roots diameters. Units: millimeter

    Change from Baseline hair roots diameters at 12 weeks

  • The change of hair density

    Soft Plus was utilized to picture and observe hair density.

    Change from Baseline hair density at 12 weeks

  • The change of hair follicle strength

    Pull up the hair of the frontal bone, temporal bone and occipital bone (approximately 60 hairs/area) to assess the number of hair loss in each area. Units: the number of loss hair

    Change from Baseline hair follicle strength at 12 weeks

  • The change of thumbs nail color

    Chroma Meter MM500 was utilized to measure thumbs nail color. Units: L\* index

    Change from Baseline thumbs nail color at 12 weeks

  • The change of nails appearence

    Picture taken was utilized to record and observe nails appearence.

    Change from Baseline nails appearence at 12 weeks

  • The change of nails growth

    Marking the position of middle fingers lunula was utilized to record and observe nails growth. Units: milimeter

    Change from Baseline marking position at 12 weeks

  • The degree of nails fragility

    Iron ruler was utilized to evaluate nails fragility. Picture taken was utilized to record and observe the change of nails fragility.

    Change from Baseline nails fragility at 12 weeks

Secondary Outcomes (1)

  • The change of self-assessment skin, hair, and nails condition

    Change from Baseline skin, hair, and nails condition at 12 weeks

Study Arms (2)

placebo drink

PLACEBO COMPARATOR
Dietary Supplement: placebo drink

Marine Collagen Peptides drinks

EXPERIMENTAL
Dietary Supplement: Marine Collagen Peptides

Interventions

Marine Collagen PeptidesDIETARY_SUPPLEMENT

consume 1 bottle per day

Also known as: Coral club Promarine Collagen Tripeptides
Marine Collagen Peptides drinks
placebo drinkDIETARY_SUPPLEMENT

consume 1 bottle per day

placebo drink

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults aged above 18 years old

You may not qualify if:

  • Subjects who are not volunteers
  • Subjects who have been diagnosed with dermatitis, cirrhosis, and chronic kidney failure
  • Subjects who have known cosmetic, drug or food allergies.
  • Patients are taking medicine for chronic diseases
  • Subjects receiving treatments for scalp, hair transplant, and other scalp medical care in past 12 weeks.
  • Subjects getting a manicure and perm in past 12 weeks.
  • Female who is pregnant or nursing or planning to become pregnant during the course of the study.
  • Subjects receiving facial laser therapy, chemical peeling or UV overexposure (\> 3 hr/week) in the past 12 weeks.
  • Students who are currently taking courses taught by the principal investigator of this trial.
  • Subjects are not willing to reveal the results of pictures after taking the product
  • Vegetarian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chia Nan University of Pharmacy & Science

Pingtung City, 928, Taiwan

Location

MeSH Terms

Conditions

Skin DiseasesNails, Ingrown

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesNail Diseases

Study Officials

  • Chia-Hua Liang, Ph.D.

    Chia Nan University of Pharmacy & Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 12, 2024

Study Start

March 4, 2024

Primary Completion

June 30, 2024

Study Completion

August 31, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations