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

August 10, 2021 updated by: Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: undenatured collagen type II (UCII) supplement
The undenatured collagen type II (UCII) supplement 40 mg will be taken once daily for 2 months.
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.
Other Names:
  • UCII

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aspartate aminotransferase value
Time Frame: 2 months
Aspartate aminotransferase value (U/L) in blood sample
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alkaline phosphatase value
Time Frame: 2 months
Alkaline phosphatase value (U/L) in blood sample
2 months
Alanine transaminase value
Time Frame: 2 months
Alanine transaminase value(U/L) in blood sample
2 months
Blood urea nitrogen value
Time Frame: 2 months
Blood urea nitrogen value (mg/dl) in blood sample
2 months
Creatinine value
Time Frame: 2 months
Creatinine value (mg/dl) in blood sample
2 months
Adverse event
Time Frame: 2 months
using questionnaire (Yes or No)
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 5, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

August 3, 2021

First Submitted That Met QC Criteria

August 10, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

August 12, 2021

Last Update Submitted That Met QC Criteria

August 10, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • EC2104220

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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