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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 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 40 participants.

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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.

Interventions

  • OTHER Placebo
  • OTHER Green Tea Extract

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2018-08-29
Est. Completion 2019-07-30
Phase NA

Sponsor

Ohio State University

552 total trials

What the Registry Record Tells You About NCT03413735

The ClinicalTrials.gov registry entry for NCT03413735 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03413735 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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