Assessment of Anti-aging Efficacy of Marine Collagen Peptides

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

Study Overview

• Status: Recruiting
• Conditions: Skin Condition; Nails, Ingrown; Hair Fragility
• Intervention / Treatment: Dietary supplement: placebo drink; Dietary supplement: Marine Collagen Peptides

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chia-Hua Liang, Ph.D.; Phone Number: 2441 +886-06-2664911; Email: tinna_ling@mail.cnu.edu.tw
• Study Contact Backup: Name: Ping Lin; Phone Number: +886-02-879778111; Email: candice.lin@tci-bio.com

Study Locations

• Taiwan
  • Pingtung, Taiwan, 928
    • Recruiting
    • Chia Nan University of Pharmacy & Science
    • Contact: Chia-Hua Liang; Phone Number: 2441 +886-06-2664911; Email: tinna_ling@mail.cnu.edu.tw
    • Contact: Ping Lin; Phone Number: +886-02-879778111; Email: candice.lin@tci-bio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy adults aged above 18 years old

Exclusion Criteria:

• 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 treaments 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo drink	Dietary supplement: placebo drink; consume 1 bottle per day
Experimental: Marine Collagen Peptides drinks	Dietary supplement: Marine Collagen Peptides; consume 1 bottle per day; Other Names: Coral Club-Promarine collagen peptides

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of self-assessment skin, hair, and nails condition	A self-assessment questionnaire was collected and evaluate skin, hair, and nails condition	Change from Baseline skin, hair, and nails condition at 12 weeks

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Chia-Hua Liang, Ph.D., Chia Nan University of Pharmacy & Science

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: fish collagen
• Additional Relevant MeSH Terms: Nail Diseases; Skin Diseases; Nails, Ingrown
• Other Study ID Numbers: 23-118-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No