Efficacy Evaluation of Collagen Drink Products

NCT06194487 — Not applicable, Completed, 91 participants, TCI Co., Ltd.

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Registry	NCT06194487
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, other
Enrollment	91 (Actual)
Sponsor	TCI Co., Ltd. (Industry)
Conditions	Skin Condition
Interventions	Placebo drink, MAXI Collagen drink, Normal fish collagen drink (Dietary supplement)
Dates	start 2023-10-01, primary completion 2023-12-29, completion 2024-01-26, first posted 2024-01-08, last updated 2024-05-06
Locations	1 site in Taiwan

-Summary

To assess MAXI Collagen drink on skin condition improvement

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+Arms and interventions

Arm	Type	Interventions	Description
Placebo drink	Placebo comparator	Dietary Supplement: Placebo drink	consume 1 bottle (50mL) per day
MAXI Collagen drink	Experimental	Dietary Supplement: MAXI Collagen drink	consume 1 bottle (50mL) per day
Normal fish collagen drink	Active comparator	Dietary Supplement: Normal fish collagen drink	consume 1 bottle (50mL) per day

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

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

Other outcomes

The change of liver function biomarkers (GOT, GPT) of blood [Day 0, Day 28]: Fasting venous blood was sampled to measure liver function biomarkers
The change of renal function biomarkers (creatinine, BUN) of blood [Day 0, Day 28]: Fasting venous blood was sampled to measure renal function biomarkers
The change of fasting blood glucose [Day 0, Day 28]: Fasting venous blood was sampled to measure blood glucose

+Eligibility

Sex: All, ages: 35 Years to 65 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Department of Applied Cosmetology, Hungkuang University	Taichung	Taiwan

+Investigators

Tzu Fang Hsu, Principal investigator, Department of Applied Cosmetology, Hungkuang University