Efficacy Testing of Collagen Drink on Skin Beauty and Sleep Aid

To assess Collagen Drink on skin condition and sleep quality improvement

Study Overview

• Status: Completed
• Conditions: Sleep Disturbance; Skin Condition
• Intervention / Treatment: Dietary supplement: Placebo drink; Dietary supplement: Collagen Juice Drink

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

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 71710
    • Chia Nan University of Pharmacy & Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adults aged above 20 years old

Exclusion Criteria:

• Subject who is not willing to participate in this study.
• Patients with diseases of the skin, liver, kidney.
• Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
• Female who is pregnant or nursing
• Constant drug use
• Received facial laser therapy, chemical peeling or UV overexposure (>3 hours everyday) in the past 4 weeks.
• Students taught by the PI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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; Blank
Experimental: Collagen drink	Dietary supplement: Collagen Juice Drink; Testing product; Other Names: LISAVEI® Collagen Juice Drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of skin wrinkles	VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units	Change from Baseline skin wrinkles at 8 weeks
The change of skin texture	VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units	Change from Baseline skin texture at 8 weeks
The change of skin collagen density	DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units	Change from Baseline skin collagen density at 8 weeks
The change of skin elasticity	Cutometer® MPA580 was utilized to measure skin elasticity. Units: arbitrary units	Change from Baseline skin elasticity at 8 weeks
The change of skin L* value	Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100	Change from Baseline L* value at 8 weeks
The change of sleep quality	Self-assessment questionnaire was utilized to survey sleep quality.	Change from Baseline sleep quality at 8 weeks
The change of AGEs of blood	Venous blood was sampled to measure AGEs	Change from Baseline AGEs at 8 weeks
The change of TIMP-1 of blood	Venous blood was sampled to measure TIMP-1	Change from Baseline TIMP-1 at 8 weeks
The change of desmosine of blood	Venous blood was sampled to measure desmosine	Change from Baseline desmosine at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of skin pores	VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units	Change from Baseline skin pores at 8 weeks
The change of skin melanin index	Soft Plus was utilized to measure skin melanin index. Units: arbitrary units	Change from Baseline skin melanin index at 8 weeks
The change of skin a* value	Chroma Meter MM500 was utilized to measure skin a* value. Units: arbitrary units	Change from Baseline skin a* value at 8 weeks
The change of skin hydration	Corneometer® CM825 was utilized to measure skin hydration. Units: arbitrary Corneometer® units 0-120	Change from Baseline skin hydration at 8 weeks
The change of transepidermal water loss	Tewameter® TM300 was utilized to measure skin hydration. Units: g/hm²	Change from Baseline transepidermal water loss at 8 weeks

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias; Skin Diseases
• Other Study ID Numbers: 21-102-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