Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults

May 28, 2025 updated by: Richard Bruno, Ohio State University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Obesity is a major public health concern in the United States, with over two-thirds of the adult population classified as overweight or obese. Obesity is characterized by low-grade chronic inflammation that, in part, is mediated by metabolic endotoxemia. Metabolic endotoxemia describes increased circulating levels of gut-derived endotoxin (a bacterial product derived from Gram-negative bacteria in the intestines) that results from gut barrier dysfunction, a phenomenon that is common in obesity. Studies in rodents models have shown that dietary supplementation with green tea extract (GTE) reduces metabolic endotoxemia in association with improved gut health. This clinical trial will therefore investigate the extent to which a green tea confection snack food can alleviate metabolic endotoxemia and restore gut health in obese humans. It is hypothesized that 4-week daily ingestion of a green tea extract (GTE)-rich confection will limit metabolic endotoxemia by decreasing gut barrier permeability. This study will address the following objectives: 1) define alterations in catechin pharmacokinetics in obese compared with healthy adults, 2) demonstrate improvements in gut barrier function by GTE, and 3) demonstrate GTE-mediated amelioration of microbial dysbiosis.

To test the hypothesis, all participants will initially complete a 12-h pharmacokinetics study to define the influence of obesity on catechin bioavailability and metabolism. They will then be randomized to complete a double-blind, randomized, placebo-controlled trial where they will receive a GTE-rich or placebo confection for 4 weeks. Prior to and upon completing the intervention, participants will undergo a gut permeability test, fecal samples will be collected for microbiota composition analysis, and blood samples will be collected to assess endotoxin and inflammatory biomarkers. Upon successfully completing this study, it is anticipated that chronic consumption of a green tea confection will be demonstrated to be an effective dietary strategy to reduce metabolic endotoxemia and improve gut health.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Overweight/obese (BMI = 28-40 kg/m2)
  • Fasting glucose < 126 mg/dL
  • Normotensive (blood pressure < 140/90 mmHg)
  • Non-dietary supplement user
  • Non-smoker

Exclusion Criteria:

  • Regular tea drinkers (> 2 cups/week)
  • Vegetarians
  • Use of medications to manage diabetes, hypertension, or hyperlipidemia
  • Use of any medications known to be contraindicated for use with green tea ingestion
  • User of dietary supplements, prebiotics, or probiotics
  • Recent use of antibiotics or anti-inflammatory agents
  • Women who are pregnant or lactating or have initiated or changed birth control in the past 3-months
  • Individuals with gastrointestinal disorders or surgeries
  • Individuals with hemochromatosis
  • Alcohol intake > 3 drinks per day
  • Any history of cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo Confection
Confection without green tea extract consumed daily for 4 weeks
Other: Placebo
Confections containing no green tea extract that will be ingested daily for 4 weeks
Experimental: Green Tea Extract-Confection
Confection with green tea extract consumed daily for 4 weeks
Other: Green Tea Extract
Confections containing green tea extract that will be ingested daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Endotoxin
Time Frame: Week 0 - Fasting
Serum endotoxin concentration
Week 0 - Fasting
Endotoxin
Time Frame: Week 2 - Fasting
Serum endotoxin concentration
Week 2 - Fasting
Endotoxin
Time Frame: Week 4 - Fasting
Serum endotoxin concentration
Week 4 - Fasting

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Calprotectin
Time Frame: Week 0
Fecal calprotectin concentration
Week 0
Calprotectin
Time Frame: Week 4
Fecal calprotectin concentration
Week 4
Gut Permeability - Lactulose to Mannitol Ratio
Time Frame: Week 0 - 0-5 hours
Urinary Lactulose/Mannitol Ratio (mg/mg)
Week 0 - 0-5 hours
Gut Permeability - Lactulose to Mannitol Ratio
Time Frame: Week 0 - 6-24 hours
Urinary Lactulose/Mannitol Ratio (mg/mg)
Week 0 - 6-24 hours
Gut Permeability - Lactulose to Mannitol Ratio
Time Frame: Week 4 - 0-5 hours
Urinary Lactulose/Mannitol Ratio (mg/mg)
Week 4 - 0-5 hours
Gut Permeability - Lactulose to Mannitol Ratio
Time Frame: Week 4 - 6-24 hours
Urinary Lactulose/Mannitol Ratio (mg/mg)
Week 4 - 6-24 hours
Gut Permeability - Sucralose to Erythritol Ratio
Time Frame: Week 0 - 6-24 hours
Urinary Sucralose/Erythritol Ratio (mg/mg)
Week 0 - 6-24 hours
Gut Permeability - Sucralose to Erythritol Ratio
Time Frame: Week 0 - 0-24 hours
Urinary Sucralose/Erythritol Ratio (mg/mg)
Week 0 - 0-24 hours
Urinary Sucralose/Erythritol Ratio (mg/mg)
Time Frame: Week 4 - 6-24 hours
Ratio of excretion of urinary sugars (Sucralose to Erythritol)
Week 4 - 6-24 hours
Gut Permeability - Sucralose to Erythritol Ratio
Time Frame: Week 4 - 0-24 hours
Urinary Sucralose/Erythritol Ratio (mg/mg)
Week 4 - 0-24 hours
Firmicutes to Bacteroidetes Ratio - Microbiota
Time Frame: Week 0
Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)
Week 0
Firmicutes to Bacteroidetes Ratio - Microbiota
Time Frame: Week 4
Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)
Week 4
Bioavailability - Epigallocatechin Gallate
Time Frame: Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection
Area under the curve (AUC) of plasma epigallocatechin calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epigallocatechin gallate is measured in umol/L over time (hours) resulting in the AUC.
Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection
Bioavailability - Epigallocatechin
Time Frame: Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection
Area under the curve (AUC) of plasma epigallocatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epigallocatechin is measured in umol/L over time (hours) resulting in the AUC.
Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection
Bioavailability - Epicatechin Gallate
Time Frame: Prior to the intervention enrollment...0-12 hours post-ingestion of a green tea confection
Area under the curve (AUC) of plasma epicatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epicatechins is measured in umol/L over time (hours) resulting in the AUC.
Prior to the intervention enrollment...0-12 hours post-ingestion of a green tea confection
Bioavailability - Epicatechin
Time Frame: Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection
Area under the curve (AUC) of plasma epicatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epicatechin is measured in umol/L over time (hours) resulting in the AUC.
Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection
Cmax of Epigallocatechin Gallate
Time Frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Cmax of Epigallocatechin
Time Frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Cmax of Epicatechin Gallate
Time Frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Cmax of Epicatechin
Time Frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Tmax of Epigallocatechin Gallate
Time Frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Tmax of Epigallocatechin
Time Frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Tmax of Epicatechin Gallate
Time Frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Tmax of Epicatechin
Time Frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard Bruno, PhD, RD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 29, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017H0246

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be published as aggregate only. Data sharing may be possible pending institutional agreements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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