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NCT03413735 · ClinicalTrials.gov registry record · NA
Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults
A NA study, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT03413735: Completed NA study, sponsored by Ohio State University.
NCT03413735 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03413735, a NA study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study is focused on assessing gastrointestinal-level improvements by which green tea limits metabolic endotoxemia. It is completed in two phases. Phase I consists of a pharmacokinetic study to examine the bioavailability of green tea catechins among lean and obese persons who consumed a single dose of a green tea extract (GTE)-containing confection. These persons will then complete phase 2, which consists of a parallel design randomized controlled in which lean and obese persons will consume placebo or GTE confections. It is expected that catechin-rich green tea will improve gut barrier function to prevent endotoxin translocation and associated low-grade inflammation. Outcomes will therefore support dietary recommendations for green tea to alleviate obesity-related inflammatory responses. Specifically, the study is expected to demonstrate that a green tea confection snack food can attenuate metabolic endotoxemia in association with restoring gastrointestinal health.
Primary Outcome
Serum endotoxin concentration
Interventions
- OTHER Placebo
- OTHER Green Tea Extract
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-08-29 |
| Est. Completion | 2019-07-30 |
| Phase | NA |
What the finished NCT03413735 record still lists
NCT03413735 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03413735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03413735 about?
NCT03413735 is a clinical study titled "Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults". This study is focused on assessing gastrointestinal-level improvements by which green tea limits metabolic endotoxemia. It is completed in two phases. Phase I consists of a pharmacokinetic study to examine the bioavailability of green tea catechins among lean and obese persons who consumed a single ...
What is the current status of trial NCT03413735?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2018-08-29. Estimated completion is 2019-07-30.
What interventions are being tested in trial NCT03413735?
The interventions under investigation include: Placebo (OTHER), Green Tea Extract (OTHER).
Who is sponsoring clinical trial NCT03413735?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03413735's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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