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NCT05002634 Clinical Trial

Safety of Undenatured Collagen Type II (UCII) Supplement in Healthy Volunteer

Health, Subjective Clinical Trial

Official title:
Safety of Undenatured Collagen Type II (UCII) Supplement in Healthy Volunteer

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05002634
Other study ID # EC2104220
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 5, 2021
Est. completion date July 31, 2022

Study information
Verified date August 2021
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will be evaluated safety of undenatured collagen type II (UCII) supplement in 60 healthy volunteer. Liver function test, renal function test, and adverse event will be assessed.

Description:

This study will be evaluated safety of undenatured collagen type II (UCII) supplement in 60 healthy volunteer. The undenatured collagen type II (UCII) supplement 40 mg will be taken once daily for 2 months. Liver function test, renal function test, and adverse event will be assessed before and after taking for 1 and 2 months.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date July 31, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: - Age 20-60 years - No taking collagen supplement more than 2 weeks - No collagen and protein allergy - No liver and renal disease - Have a willingness to participate in the study Exclusion Criteria: - Uncontrolled disease - Have complication symptom during study - Pregnancy or lactation - Cannot follow the protocol - During participated in other studies

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• undenatured collagen type II (UCII) supplement
The undenatured collagen type II (UCII) supplement 40 mg will be taken once daily for 2 months.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Chulalongkorn University

Outcome
Type Measure Description Time frame Safety issue
Primary Aspartate aminotransferase value Aspartate aminotransferase value (U/L) in blood sample 2 months
Secondary Alkaline phosphatase value Alkaline phosphatase value (U/L) in blood sample 2 months
Secondary Alanine transaminase value Alanine transaminase value(U/L) in blood sample 2 months
Secondary Blood urea nitrogen value Blood urea nitrogen value (mg/dl) in blood sample 2 months
Secondary Creatinine value Creatinine value (mg/dl) in blood sample 2 months
Secondary Adverse event using questionnaire (Yes or No) 2 months
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