NCT03973996

Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome

Completed NA Results posted Last updated 19 December 2025

What this trial tests

NA trial testing Green Tea Extract in Dysbiosis in 46 participants. Completed in 1 March 2021.

Timeline

1 July 2019

Primary endpoint
1 March 2021

1 March 2021

Quick facts

Lead sponsor	Ohio State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	prevention
Enrollment	46
Start date	1 July 2019
Primary completion	1 March 2021
Estimated completion	1 March 2021
Sites	1 location across United States

Drugs / interventions tested

• Green Tea Extract — full drug profile →
• Placebo

Conditions studied

• Dysbiosis — all drugs for Dysbiosis →
• Endotoxemia — all drugs for Endotoxemia →
• Metabolic Syndrome — all drugs for Metabolic Syndrome →
• Inflammation — all drugs for Inflammation →

Sponsor

Ohio State University

Who can join

Adults 18 to 65, any sex, with Dysbiosis 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.

Serum Endotoxin Primary · Day 28

Data are biomarker fasting concentrations.

Group	Value	95% CI
Healthy - Placebo	31.6	± 2.5
Healthy - GTE	26.7	± 2.6
MetS - Placebo	44.5	± 2.4
MetS - GTE	39.1	± 2.5

Plasma Lipopolysaccharide-binding Protein Secondary · Day 28

Data are biomarker fasting concentrations

Group	Value	95% CI
Healthy - Placebo	4035	± 339
Healthy - GTE	4435	± 380
MetS - Placebo	7890	± 1143
MetS - GTE	8572	± 1394

Urinary Lactulose/Mannitol Ratio Secondary · Day 28

Lactulose/mannitol ratio in urine collected 0-5 h post-ingestion of non-digestible sugar probes.

Group	Value	95% CI
Healthy - GTE	0.075	± 0.009
Healthy - Placebo	0.084	± 0.012
MetS - Placebo	0.087	± 0.013
MetS - GTE	0.065	± 0.007

Urinary Sucralose/Erythritol Ratio Secondary · Day 28

Sucralose/Erythritol ratio measured in urine collected 0-24 h post-ingestion of non-digestible sugar probes

Group	Value	95% CI
Healthy - Placebo	0.014	± 0.0014
Healthy - GTE	0.014	± 0.0015
MetS - Placebo	0.015	± 0.001
MetS - GTE	0.015	± 0.001

Plasma Interleukin-6 Secondary · Day 28

Data are biomarker concentrations at fasting

Group	Value	95% CI
Healthy - Placebo	1.9	± 0.085
Healthy - GTE	1.9	± 0.070
MetS - Placebo	3.1	± 0.24
MetS - GTE	3.3	± 0.29

Fecal Calprotectin Secondary · Day 25-27 (pooled samples) of the 28-day intervention

Data are biomarker fecal concentrations, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.

Group	Value	95% CI
Healthy - Placebo	35.9	± 5.5
Healthy - GTE	24.4	± 2.7
MetS - Placebo	42.5	± 9.3
MetS - GTE	36.7	± 5.2

Fecal Myeloperoxidase Secondary · Day 25-27 (pooled samples) of the 28-day intervention

Data are biomarker fecal concentrations, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.

Group	Value	95% CI
Healthy - Placebo	97.4	± 9.9
Healthy - GTE	83.4	± 7.5
MetS - Placebo	148.1	± 40.9
MetS - GTE	97.9	± 10.5

Plasma Epigallocatechin Gallate Secondary · Day 28

Data are plasma concentrations of epigallocatechin gallate

Group	Value	95% CI
Healthy - Placebo	0.001	± 0.001
Healthy - GTE	0.343	± 0.057
MetS - Placebo	0.00	± 0.00
MetS - GTE	0.21	± 0.04

Plasma Epicatechin Secondary · Day 28

Data are plasma concentrations of epicatechin.

Group	Value	95% CI
Healthy - Placebo	0.0	± 0.0
Healthy - GTE	0.022	± 0.0048
MetS - Placebo	0.00016	± 0.00016
MetS - GTE	0.015	± 0.003

Plasma Epicatechin Gallate Secondary · Day 28

Data are plasma concentrations of epicatechin gallate.

Group	Value	95% CI
Healthy - Placebo	0.002	± 0.001
Healthy - GTE	0.30	± 0.037
MetS - Placebo	0.002	± 0.001
MetS - GTE	0.20	± 0.027

Plasma 3,4-γ-valerolactone Secondary · Day 28

Data are biomarker concentrations at fasting

Group	Value	95% CI
Healthy - Placebo	0.008	± 0.005
Healthy - GTE	0.17	± 0.050
MetS - Placebo	0.007	± 0.003
MetS - GTE	0.090	± 0.031

Plasma 3,4,5-γ-Valerolactone Secondary · Day 28

Data are biomarker concentrations at fasting

Group	Value	95% CI
Healthy - Placebo	0.001	± 0.001
Healthy - GTE	0.034	± 0.017
MetS - Placebo	0.0017	± 0.0010
MetS - GTE	0.0060	± 0.0047

Sponsor's own description

This study evaluates dietary green tea extract to improve gut health and inflammation in persons with metabolic syndrome and healthy adults. Participants will complete two phases of intervention in random order in which they will consume green tea extract or placebo for one month and then switch to the opposite treatment for an additional month.

Publications & conference data

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

1. Intestinal-level anti-inflammatory bioactivities of catechin-rich green tea: Rationale, design, and methods of a double-blind, randomized, placebo-controlled crossover trial in metabolic syndrome and healthy adults.
   Hodges JK, Zhu J, Yu Z, Vodovotz Y, et al · · 2020 · cited 30× · PMID 31799477 · DOI 10.1016/j.conctc.2019.100495
2. Alcohol Use and Abuse Conspires With HIV Infection to Aggravate Intestinal Dysbiosis and Increase Microbial Translocation in People Living With HIV: A Review.
   Yan J, Ouyang J, Isnard S, Zhou X, et al · · 2021 · cited 11× · PMID 34975838 · DOI 10.3389/fimmu.2021.741658
3. Effects of Differently Processed Tea on the Gut Microbiota.
   Zhao Z, Chen R, Ng K. · · 2024 · cited 5× · PMID 39274868 · DOI 10.3390/molecules29174020
4. In vivo and in vitro perspectives in Parkinson's disease: Mechanisms and the role of phytomedicine.
   Singh J, Kumar D. · · 2025 · cited 1× · PMID 41066749 · DOI 10.38212/2224-6614.3557