Efficacy Testing of Collagen and Zhuyin Drinks

To assess collagen and zhuyin drink on skin & body condition improvement

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 50
• 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 to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).
• Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
• Female who is pregnant or nursing or planning to become pregnant during the course of the study.
• Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
• Vegetarian
• Subjects who have large spots (area >3 square centimeter) or abnormal acne.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo drink	Dietary supplement: Placebo drink; consume 1 bottle (50 mL) per day for 28 days
Experimental: Collagen and Zhuyin Drinks	Dietary supplement: Collagen Cubilose Drink; consume 1 bottle (50 mL) per day for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of skin moisture	Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120	Change from Baseline skin moisture at 4 weeks
The change of skin wrinkles	VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units	Change from Baseline skin wrinkles at 4 weeks
The change of skin collagen density	DermaLab® USB - 20 MHz High Freq. Ultrasound probe was utilized to scan and analyze skin collagen density. Units:Intensity score	Change from Baseline skin collagen density at 4 weeks
The change of TEWL	Tewameter® TM 300 was utilized to measure TEWL. Units: g/h/m2	Change from Baseline TEWL at 4 weeks
The change of skin brightness	Glossymeter GL 200 was utilized to measure skin brightness. Units: arbitrary units	Change from Baseline skin brightness at 4 weeks
The change of interleukin-6	Venous blood was sampled to measure concentrations of interleukin-6.	Change from Baseline skin brightness at 4 weeks
The change of interleukin-8	Venous blood was sampled to measure concentrations of interleukin-8.	Change from Baseline skin brightness at 4 weeks
The change of Tumor necrosis factor	Venous blood was sampled to measure concentrations of Tumor necrosis factor.	Change from Baseline skin brightness at 4 weeks
The change of Matrix metalloproteinase-1	Venous blood was sampled to measure concentrations of Matrix metalloproteinase-1 .	Change from Baseline skin brightness at 4 weeks
The change of metallopeptidase inhibitor 1	Venous blood was sampled to measure concentrations of metallopeptidase inhibitor 1.	Change from Baseline skin brightness at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of skin texture	VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units	Change from Baseline skin texture at 4 weeks
The change of skin pores	VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units	Change from Baseline skin pores at 4 weeks
The change of skin spots	VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units	Change from Baseline skin spots at 4 weeks
The change of red areas	VISIA Complexion Analysis System was utilized to measure red areas. Units: arbitrary units	Change from Baseline red areas at 4 weeks

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2020
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: 20-003-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