Efficacy Testing of Collagen and Zhuyin Drinks

NCT04266405 | Completed

• 1 other identifier: 20-003-B
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Condition

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (4)

• The change of skin texture

  Change from Baseline skin texture at 4 weeks

• The change of skin pores

  Change from Baseline skin pores at 4 weeks

• The change of skin spots

  Change from Baseline skin spots at 4 weeks

• The change of red areas

  Change from Baseline red areas at 4 weeks

Study Arms (2)

Placebo drink

PLACEBO COMPARATOR

Dietary Supplement: Placebo drink

Collagen and Zhuyin Drinks

EXPERIMENTAL

Dietary Supplement: Collagen Cubilose Drink

Interventions

Placebo drink DIETARY_SUPPLEMENT

consume 1 bottle (50 mL) per day for 28 days

Placebo drink

Collagen Cubilose Drink DIETARY_SUPPLEMENT

consume 1 bottle (50 mL) per day for 28 days

Collagen and Zhuyin Drinks

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults aged above 20 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

Chia Nan University of Pharmacy ＆ Science

Tainan, 71710, Taiwan

Location

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: March 9, 2020
• Primary Completion: July 31, 2020
• Study Completion: December 1, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

TW (1)