NCT03413735

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

Completed NA Results posted Last updated 13 June 2025

What this trial tests

NA trial testing Green Tea Extract in Obesity in 40 participants. Completed in 30 July 2019.

Timeline

29 August 2018

Primary endpoint
30 July 2019

30 July 2019

Quick facts

Lead sponsor	Ohio State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	40
Start date	29 August 2018
Primary completion	30 July 2019
Estimated completion	30 July 2019
Sites	1 location across United States

Drugs / interventions tested

• Green Tea Extract — full drug profile →
• Placebo

Conditions studied

• Obesity — all drugs for Obesity →
• Endotoxemia — all drugs for Endotoxemia →
• Inflammation — all drugs for Inflammation →

Sponsor

Ohio State University

Who can join

Adults 18 to 50, any sex, with Obesity or Endotoxemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Endotoxin Primary · Week 0 - Fasting

Serum endotoxin concentration

Group	Value	95% CI
Lean - GTE	14.44	± 4.46
Obese - GTE	12.97	± 6.44
Lean - Placebo	12.25	± 6.05
Obese - Placebo	17.65	± 12.58

Endotoxin Primary · Week 2 - Fasting

Serum endotoxin concentration

Group	Value	95% CI
Lean - GTE	13.59	± 7.38
Obese - GTE	12.38	± 7.53
Lean - Placebo	13.00	± 5.44
Obese - Placebo	15.62	± 5.32

Endotoxin Primary · Week 4 - Fasting

Serum endotoxin concentration

Group	Value	95% CI
Lean	12.33	± 4.55
Obese	16.46	± 4.91
Lean - Placebo	11.33	± 5.56
Obese - Placebo	15.45	± 6.94

Gut Permeability - Lactulose to Mannitol Ratio Secondary · Week 0 - 0-5 hours

Urinary Lactulose/Mannitol Ratio (mg/mg)

Group	Value	95% CI
Lean - GTE	0.12	± 0.06
Obese - GTE	0.09	± 0.03
Lean - Placebo	0.10	± 0.05
Obese - Placebo	0.10	± 0.03

Gut Permeability - Lactulose to Mannitol Ratio Secondary · Week 0 - 6-24 hours

Urinary Lactulose/Mannitol Ratio (mg/mg)

Group	Value	95% CI
Lean - GTE	0.16	± 0.10
Obese - GTE	0.11	± 0.10
Lean - Placebo	0.19	± 0.12
Obese - Placebo	0.19	± 0.14

Gut Permeability - Lactulose to Mannitol Ratio Secondary · Week 4 - 0-5 hours

Urinary Lactulose/Mannitol Ratio (mg/mg)

Group	Value	95% CI
Lean - GTE	0.12	± 0.13
Obese - GTE	0.14	± 0.10
Lean - Placebo	0.10	± 0.06
Obese - Placebo	0.12	± 0.08

Gut Permeability - Lactulose to Mannitol Ratio Secondary · Week 4 - 6-24 hours

Urinary Lactulose/Mannitol Ratio (mg/mg)

Group	Value	95% CI
Lean - GTE	0.14	± 0.11
Obese - GTE	0.18	± 0.18
Lean - Placebo	0.19	± 0.12
Obese - Placebo	0.21	± 0.12

Gut Permeability - Sucralose to Erythritol Ratio Secondary · Week 0 - 6-24 hours

Urinary Sucralose/Erythritol Ratio (mg/mg)

Group	Value	95% CI
Lean - GTE	0.02	± 0.01
Obese - GTE	0.02	± 0.01
Lean - Placebo	0.02	± 0.01
Obese - Placebo	0.02	± 0.01

Gut Permeability - Sucralose to Erythritol Ratio Secondary · Week 0 - 0-24 hours

Urinary Sucralose/Erythritol Ratio (mg/mg)

Group	Value	95% CI
Lean - GTE	0.02	± 0.01
Obese - GTE	0.02	± 0.01
Lean - Placebo	0.02	± 0.004
Obese - Placebo	0.02	± 0.004

Urinary Sucralose/Erythritol Ratio (mg/mg) Secondary · Week 4 - 6-24 hours

Ratio of excretion of urinary sugars (Sucralose to Erythritol)

Group	Value	95% CI
Lean - GTE	0.01	± 0.01
Obese - GTE	0.01	± 0.01
Lean - Placebo	0.02	± 0.01
Obese - Placebo	0.02	± 0.02

Gut Permeability - Sucralose to Erythritol Ratio Secondary · Week 4 - 0-24 hours

Urinary Sucralose/Erythritol Ratio (mg/mg)

Group	Value	95% CI
Lean - GTE	0.01	± 0.02
Obese - GTE	0.02	± 0.01
Lean - Placebo	0.02	± 0.01
Obese - Placebo	0.02	± 0.01

Firmicutes to Bacteroidetes Ratio - Microbiota Secondary · Week 0

Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)

Group	Value	95% CI
Lean - GTE	4.34	± 3.17
Obese - GTE	3.52	± 2.32
Lean - Placebo	21.51	± 31.65
Obese - Placebo	9.36	± 7.48

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phytochemicals in the treatment of inflammation-associated diseases: the journey from preclinical trials to clinical practice.
   Nisar A, Jagtap S, Vyavahare S, Deshpande M, et al · · 2023 · cited 49× · PMID 37229273 · DOI 10.3389/fphar.2023.1177050
2. Gallation and B-Ring Dihydroxylation Increase Green Tea Catechin Residence Time in Plasma by Differentially Affecting Tissue-Specific Trafficking: Compartmental Model of Catechin Kinetics in Healthy Adults.
   Hodges JK, Sasaki GY, Vodovotz Y, Bruno RS. · · 2023 · cited 1× · PMID 37764804 · DOI 10.3390/nu15184021