N/A
N=40
Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults
Obesity · Endotoxemia · Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT03413735 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Endotoxin — 14.44; 12.97; 12.25; 17.65 EU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Green Tea Extract (Other); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endotoxin |
12.33; 16.46; 11.33; 15.45 | — |
| PRIMARY Endotoxin |
12.33; 16.46; 11.33; 15.45 | — |
| PRIMARY Endotoxin |
12.33; 16.46; 11.33; 15.45 | — |
| SECONDARY Gut Permeability - Lactulose to Mannitol Ratio |
0.14; 0.18; 0.19; 0.21 | — |
| SECONDARY Gut Permeability - Lactulose to Mannitol Ratio |
0.14; 0.18; 0.19; 0.21 | — |
| SECONDARY Gut Permeability - Lactulose to Mannitol Ratio |
0.14; 0.18; 0.19; 0.21 | — |
| SECONDARY Gut Permeability - Lactulose to Mannitol Ratio |
0.14; 0.18; 0.19; 0.21 | — |
| SECONDARY Gut Permeability - Sucralose to Erythritol Ratio |
0.01; 0.02; 0.02; 0.02 | — |
| SECONDARY Gut Permeability - Sucralose to Erythritol Ratio |
0.01; 0.02; 0.02; 0.02 | — |
| SECONDARY Urinary Sucralose/Erythritol Ratio (mg/mg) |
0.01; 0.01; 0.02; 0.02 | — |
| SECONDARY Gut Permeability - Sucralose to Erythritol Ratio |
0.01; 0.02; 0.02; 0.02 | — |
| SECONDARY Firmicutes to Bacteroidetes Ratio - Microbiota |
4.90; 8.95; 4.69; 9.32 | — |
| SECONDARY Firmicutes to Bacteroidetes Ratio - Microbiota |
4.90; 8.95; 4.69; 9.32 | — |
| SECONDARY Bioavailability - Epigallocatechin Gallate |
3.46; 2.62 | — |
| SECONDARY Bioavailability - Epigallocatechin |
1.18; 0.88 | — |
| SECONDARY Bioavailability - Epicatechin Gallate |
1.06; 0.78 | — |
| SECONDARY Bioavailability - Epicatechin |
0.78; 0.57 | — |
| SECONDARY Cmax of Epigallocatechin Gallate |
0.5; 0.38 | — |
| SECONDARY Cmax of Epigallocatechin |
0.22; 0.18 | — |
| SECONDARY Cmax of Epicatechin Gallate |
0.14; 0.09 | — |
| SECONDARY Cmax of Epicatechin |
0.16; 0.13 | — |
| SECONDARY Tmax of Epigallocatechin Gallate |
3.32; 2.65 | — |
| SECONDARY Tmax of Epigallocatechin |
1.92; 1.41 | — |
| SECONDARY Tmax of Epicatechin Gallate |
4.05; 3.94 | — |
| SECONDARY Tmax of Epicatechin |
1.66; 1.53 | — |
| SECONDARY Calprotectin |
249.62; 25.74; 36.20; 73.04 | — |
| SECONDARY Calprotectin |
249.62; 25.74; 36.20; 73.04 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Overweight/obese (BMI = 28-40 kg/m2)
- Fasting glucose 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
Data sourced from ClinicalTrials.gov (NCT03413735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.