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

Sponsor
Chulalongkorn University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05002634
Collaborator
(none)
60
Enrollment
1
Arm
11.8
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Dietary Supplement: undenatured collagen type II (UCII) supplement
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Safety of Undenatured Collagen Type II (UCII) Supplement in Healthy Volunteer
Anticipated Study Start Date :
Aug 5, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

ArmIntervention/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
  • Outcome Measures

    Primary Outcome Measures

    1. Aspartate aminotransferase value [2 months]

      Aspartate aminotransferase value (U/L) in blood sample

    Secondary Outcome Measures

    1. Alkaline phosphatase value [2 months]

      Alkaline phosphatase value (U/L) in blood sample

    2. Alanine transaminase value [2 months]

      Alanine transaminase value(U/L) in blood sample

    3. Blood urea nitrogen value [2 months]

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

    4. Creatinine value [2 months]

      Creatinine value (mg/dl) in blood sample

    5. Adverse event [2 months]

      using questionnaire (Yes or No)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Chulalongkorn University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pornanong Aramwit, Pharm.D., Ph.D, Professor, Chulalongkorn University
    ClinicalTrials.gov Identifier:
    NCT05002634
    Other Study ID Numbers:
    • EC2104220
    First Posted:
    Aug 12, 2021
    Last Update Posted:
    Aug 12, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 12, 2021