NCT05002634

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

August 5, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

August 3, 2021

Last Update Submit

August 10, 2021

Conditions

Health, Subjective

Outcome Measures

Primary Outcomes (1)

  • Aspartate aminotransferase value

    Aspartate aminotransferase value (U/L) in blood sample

    2 months

Secondary Outcomes (5)

  • Alkaline phosphatase value

    2 months

  • Alanine transaminase value

    2 months

  • Blood urea nitrogen value

    2 months

  • Creatinine value

    2 months

  • Adverse event

    2 months

Study Arms (1)

undenatured collagen type II (UCII) supplement

EXPERIMENTAL

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

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.

Also known as: UCII
undenatured collagen type II (UCII) supplement

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Uncontrolled disease
  • Have complication symptom during study
  • Pregnancy or lactation
  • Cannot follow the protocol
  • During participated in other studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 12, 2021

Study Start

August 5, 2021

Primary Completion

June 30, 2022

Study Completion

July 31, 2022

Last Updated

August 12, 2021

Record last verified: 2021-08