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

Chulalongkorn University60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Health, Subjective

Interventions

undenatured collagen type II (UCII) supplementDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Aspartate aminotransferase value

Aspartate aminotransferase value (U/L) in blood sample

Time frame: 2 months

Secondary Outcomes

Alkaline phosphatase value

Alkaline phosphatase value (U/L) in blood sample

Time frame: 2 months

Alanine transaminase value

Alanine transaminase value(U/L) in blood sample

Time frame: 2 months

Blood urea nitrogen value

Blood urea nitrogen value (mg/dl) in blood sample

Time frame: 2 months

Creatinine value

Creatinine value (mg/dl) in blood sample

Time frame: 2 months

Adverse event

using questionnaire (Yes or No)

Time frame: 2 months

Data from ClinicalTrials.gov

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