Health, SubjectiveNCT05002634
Safety of Undenatured Collagen Type II (UCII) Supplement in Healthy Volunteer
A study testing undenatured collagen type II (UCII) supplement in people with Health, Subjective, run by Chulalongkorn University.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective
- What is being tested?
- undenatured collagen type II (UCII) supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Uncontrolled disease
- Have complication symptom during study
- Pregnancy or lactation
- Cannot follow the protocol
- During participated in other studies
About this study
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.
Read the 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.
- Conditions
- Health, Subjective
- Being tested
- undenatured collagen type II (UCII) supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
undenatured collagen type II (UCII) supplementDietary supplement
Also called UCII
The undenatured collagen type II (UCII) supplement 40 mg will be taken once daily for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| undenatured collagen type II (UCII) supplement | Experimental | The undenatured collagen type II (UCII) supplement 40 mg will be taken once daily for 2 months. Receives: Dietary Supplement: undenatured collagen type II (UCII) supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aspartate aminotransferase value
Aspartate aminotransferase value (U/L) in blood sample
Measured: 2 months
Secondary outcomes (5)
Alkaline phosphatase value
Alkaline phosphatase value (U/L) in blood sample
Measured: 2 months
Alanine transaminase value
Alanine transaminase value(U/L) in blood sample
Measured: 2 months
Blood urea nitrogen value
Blood urea nitrogen value (mg/dl) in blood sample
Measured: 2 months
Creatinine value
Creatinine value (mg/dl) in blood sample
Measured: 2 months
Adverse event
using questionnaire (Yes or No)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start5 Aug 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002634
- Sponsor's protocol ID
- EC2104220
- Status last verified
- Aug 2021
- First submitted
- 3 Aug 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Undenatured Collagen Type II (UCII) Supplement in Healthy Volunteer
- ClinicalTrials.gov ID
- NCT05002634
- Acronym / sponsor ID
- EC2104220
- Conditions
- Health, Subjective
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 5 Aug 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| undenatured collagen type II (UCII) supplement | Experimental | Dietary Supplement: undenatured collagen type II (UCII) supplementThe undenatured collagen type II (UCII) supplement 40 mg will be taken once daily for 2 months. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Uncontrolled disease
- Have complication symptom during study
- Pregnancy or lactation
- Cannot follow the protocol
- During participated in other studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| undenatured collagen type II (UCII) supplementAlso: UCIIThe undenatured collagen type II (UCII) supplement 40 mg will be taken once daily for 2 months. | Dietary supplement | undenatured collagen type II (UCII) supplement |
Primary outcome
Aspartate aminotransferase value
Time frame: 2 months
Aspartate aminotransferase value (U/L) in blood sample
5 secondary outcomes
Alkaline phosphatase value
Time frame: 2 months
Alanine transaminase value
Time frame: 2 months
Blood urea nitrogen value
Time frame: 2 months
Creatinine value
Time frame: 2 months
Adverse event
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing undenatured collagen type II (UCII) supplement in people with Health, Subjective, run by Chulalongkorn University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aspartate aminotransferase value (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.