Efficacy Evaluation of Collagen Drink Products

Skin Condition Clinical Trial

Official title:

Efficacy Evaluation of Collagen Drink Products

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06194487
• Other study ID #: 23-073-A
• Status: Completed
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: January 26, 2024

Study information

• Verified date: May 2024
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess MAXI Collagen drink on skin condition improvement

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 26, 2024
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin Condition
• Skin Diseases

Intervention

Dietary Supplement:
• Placebo drink
consume 1 bottle (50mL) per day
• MAXI Collagen drink
consume 1 bottle (50mL) per day
• Normal fish collagen drink
consume 1 bottle (50mL) per day

Locations

Country	Name	City	State
Taiwan	Department of Applied Cosmetology, Hungkuang University	Taichung City

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The change of liver function biomarkers (GOT, GPT) of blood	Fasting venous blood was sampled to measure liver function biomarkers	Day 0, Day 28
Other	The change of renal function biomarkers (creatinine, BUN) of blood	Fasting venous blood was sampled to measure renal function biomarkers	Day 0, Day 28
Other	The change of fasting blood glucose	Fasting venous blood was sampled to measure blood glucose	Day 0, Day 28
Primary	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
Primary	The change of skin elasticity	Cutometer® Dual MPA 580 was utilized to measure skin elasticity. Units: arbitrary units	Day 0, Day 7, Day 28
Primary	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
Primary	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	The change of transepidermal water loss (TEWL)	Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²	Day 0, Day 7, Day 28
Secondary	The change of skin wrinkles	VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units	Day 0, Day 7, Day 28
Secondary	The change of skin pores	VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units	Day 0, Day 7, Day 28
Secondary	The change of skin colour	PANTONE® CAPSURE™ RM200-PT01 was utilized to measure skin colour. Units: arbitrary units	Day 0, Day 7, Day 28
Secondary	The change of self-assessment skin condition	A self-assessment questionnaire was collected to evaluate skin condition	Day 0, Day 7, Day 28