Efficacy Evaluation of Collagen Drink Products

To assess MAXI Collagen drink on skin condition improvement

Study Overview

• Status: Completed
• Conditions: Skin Condition
• Intervention / Treatment: Dietary supplement: Placebo drink; Dietary supplement: MAXI Collagen drink; Dietary supplement: Normal fish collagen drink

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung City, Taiwan, 433304
    • Department of Applied Cosmetology, Hungkuang University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Healthy adults aged 35-65 years old

Exclusion Criteria:

• Subject with skin surface damage larger than $50 coin area.
• Subject who had skin allergies caused by diet or undrwent cosmetic or medical treatment within 6 months.
• Subject who is a vegetarian and allergic to seafood, alcohol or listed ingredients in the product.
• Students who are currently taking courses taught by the principal investigator of this trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo drink; consume 1 bottle (50mL) per day	Dietary supplement: Placebo drink; consume 1 bottle (50mL) per day
Experimental: MAXI Collagen drink; consume 1 bottle (50mL) per day	Dietary supplement: MAXI Collagen drink; consume 1 bottle (50mL) per day
Active Comparator: Normal fish collagen drink; consume 1 bottle (50mL) per day	Dietary supplement: Normal fish collagen drink; consume 1 bottle (50mL) per day

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	Day 0, Day 7, Day 28
The change of skin elasticity	Cutometer® Dual MPA 580 was utilized to measure skin elasticity. Units: arbitrary units	Day 0, Day 7, Day 28
The change of skin moisture	Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120	Day 0, Day 7, Day 28
The change of skin texture	VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units	Day 0, Day 7, Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of transepidermal water loss (TEWL)	Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²	Day 0, Day 7, Day 28
The change of skin wrinkles	VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units	Day 0, Day 7, Day 28
The change of skin pores	VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units	Day 0, Day 7, Day 28
The change of skin colour	PANTONE® CAPSURE™ RM200-PT01 was utilized to measure skin colour. Units: arbitrary units	Day 0, Day 7, Day 28
The change of self-assessment skin condition	A self-assessment questionnaire was collected to evaluate skin condition	Day 0, Day 7, Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of liver function biomarkers (GOT, GPT) of blood	Fasting venous blood was sampled to measure liver function biomarkers	Day 0, Day 28
The change of renal function biomarkers (creatinine, BUN) of blood	Fasting venous blood was sampled to measure renal function biomarkers	Day 0, Day 28
The change of fasting blood glucose	Fasting venous blood was sampled to measure blood glucose	Day 0, Day 28

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Tzu Fang Hsu, Department of Applied Cosmetology, Hungkuang University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): January 26, 2024

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: 23-073-A

Drug and device information, study documents

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