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NCT03234062 · ClinicalTrials.gov registry record · NA
Developing a Biomarker Panel to Assess Choline Nutritional Status
A NA study of Healthy, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03234062: Completed NA study of Healthy, sponsored by University of North Carolina, Chapel Hill.
NCT03234062 is a NA study of Healthy that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 16 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03234062, a NA study of Healthy, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
People who eat diets low in choline (LC) should deplete their choline (Cho) stores, and measurements of Cho pool size using isotope dilution should reflect this depletion. Investigators will identify a biomarker panel that correlates well with measured Cho pool size across the range of different degrees of depletion.The investigators propose that, as body stores of Cho diminish, cells and organs will reach the point when metabolism/function in the cell is altered, and that this will result in a progression of changes in biomarkers that reflect Cho status.
Primary Outcome
The investigator will evaluate direct measures of Choline derived pools and using isotope dilution will provide an estimate of the size of the body pool of choline, while also profiling choline-related metabolites. MRS/MRI will assess Cho compounds in liver and fatty liver (also used to validate Fibroscan) to confirm measures utilizing isotope dilution.
Conditions Studied
Interventions
- OTHER 25% Cho diet
- OTHER 50% Cho diet
- OTHER 100% Cho diet
Study Locations (1)
North Carolina
- UNC Chapel Hill Nutrition Research Institute - Kannapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-02-15 |
| Est. Completion | 2018-10-18 |
| Phase | NA |
What the finished NCT03234062 record still lists
NCT03234062 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which 25% Cho diet is the first listed.
NCT03234062 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03234062 about?
NCT03234062 is a clinical study titled "Developing a Biomarker Panel to Assess Choline Nutritional Status". People who eat diets low in choline (LC) should deplete their choline (Cho) stores, and measurements of Cho pool size using isotope dilution should reflect this depletion. Investigators will identify a biomarker panel that correlates well with measured Cho pool size across the range of different deg...
What is the current status of trial NCT03234062?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2018-02-15. Estimated completion is 2018-10-18.
What conditions does trial NCT03234062 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT03234062?
The interventions under investigation include: 25% Cho diet (OTHER), 50% Cho diet (OTHER), 100% Cho diet (OTHER).
Who is sponsoring clinical trial NCT03234062?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03234062 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03234062's enrollment target sits among peer trials
16 936th of 1090 higher than 137 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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