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NCT03427879 · ClinicalTrials.gov registry record · Phase 1
Effect of Flavonoids on Gut Permeability in Cyclists
A Phase 1 study, sponsored by Utah State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03427879: Completed Phase 1 study, sponsored by Utah State University.
NCT03427879 is a Phase 1 study that has completed, run by Utah State University. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03427879, a Phase 1 study, has completed, sponsored by Utah State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this investigation is to test the hypothesis that chronic supplementation with a dairy-based beverage containing a mixture of blueberry, green tea, and cocoa flavonoids (non-nutritive natural plant compounds) will ameliorate exercise-related changes in gut permeability and inflammation. In a previous feeding study in humans, (NCT02728570) a high flavonoid diet (flavonoids at 340 mg/1000kcal) was effective in mitigating gut permeability and inflammation in overweight and obese adults compared to a low flavonoid diet (10mg/1000 kcal). To test this hypothesis, 20 trained cyclists will complete a randomized crossover study with supplementation for 2 weeks with a dairy-based sports beverage containing either a high flavonoid (approximately 620 mg) or low flavonoid (approximately 5mg) beverage. After the two week intervention, cyclists will complete a 1 hour cycling trial (45 min at 65% VO2 max then 15 minute time trial). The primary endpoints will be gut permeability as measured by plasma intestinal fatty acid binding protein (I-FABP) and the differential sugar test. Secondary endpoints will include gut inflammation (measured via fecal calprotectin), plasma cytokines (IL-6, IL-10 and TNFα) and plasma LPS. In addition, the distance completed in the time trial is a secondary endpoint.
Primary Outcome
Measure of gut permeability from mouth to end of small intestine. Ratio of urinary lactulose to mannitol after subject consumes a beverage containing these sugars. Sugars in urine are measured by gas chromatography with flame ionization detection.
Interventions
- DRUG Low flavonoid beverage
- DRUG High flavonoid beverage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-09-14 |
| Est. Completion | 2019-07-31 |
| Phase | Phase 1 |
What the finished NCT03427879 record still lists
NCT03427879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Low flavonoid beverage is the first listed.
NCT03427879 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03427879 about?
NCT03427879 is a clinical study titled "Effect of Flavonoids on Gut Permeability in Cyclists". The purpose of this investigation is to test the hypothesis that chronic supplementation with a dairy-based beverage containing a mixture of blueberry, green tea, and cocoa flavonoids (non-nutritive natural plant compounds) will ameliorate exercise-related changes in gut permeability and inflammatio...
What is the current status of trial NCT03427879?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2018-09-14. Estimated completion is 2019-07-31.
What interventions are being tested in trial NCT03427879?
The interventions under investigation include: Low flavonoid beverage (DRUG), High flavonoid beverage (DRUG).
Who is sponsoring clinical trial NCT03427879?
This trial is sponsored by Utah State University, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03427879's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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