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

Not Applicable

• Conditions: Obesity; Endotoxemia; Inflammation
• Interventions: Other: Placebo; Other: Green Tea Extract

• Registration Number: NCT03413735
• Lead Sponsor: Ohio State University

Brief Summary

This study is focused on assessing gastrointestinal-level improvements by which green tea limits metabolic endotoxemia. 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.

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 complete a 12-h pharmacokinetics study to define the influence of obesity on catechin bioavailability and metabolism. They will then 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Study Start: 2018-08-29
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-04
• Last Update Posted: 2021-12-07
• Primary Completion: 2022-03-30
• Study Completion: 2023-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Confection	Placebo	Confection without green tea extract consumed daily for 4 weeks
Green Tea Extract-Confection	Green Tea Extract	Confection with green tea extract consumed daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Endotoxin	Week 4 - Fasting	Serum endotoxin concentration

Secondary Outcome Measures

Name	Time	Method
Gut Permeability - Lactulose to Mannitol Ratio	Week 4 - 6-24 hours	Ratio of excretion of urinary sugars
Firmicutes to Bacteroidetes Ratio - Microbiota	Week 4	Ratio of relative abundances of Firmicutes to Bacteroidetes in feces
Bioavailability - Epigallocatechin	0-12 hours post-ingestion of a green tea confection	Area under the curve (AUC) of plasma 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
Cmax of Epigallocatechin gallate	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
Cmax of Epigallocatechin	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
Bioavailability - Epigallocatechin gallate	0-12 hours post-ingestion of a green tea confection	Area under the curve (AUC) of plasma 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
Bioavailability - Epicatechin gallate	0-12 hours post-ingestion of a green tea confection	Area under the curve (AUC) of plasma 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
Gut Permeability - Sucralose to Erythritol Ratio	Week 4 - 6-24 hours	Ratio of excretion of urinary sugars
Bioavailability - Epicatechin	0-12 hours post-ingestion of a green tea confection	Area under the curve (AUC) of plasma 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
Cmax of Epicatechin	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
Calprotectin	Week 4	Fecal calprotectin concentration
Tmax of Epigallocatechin gallate	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
Tmax of Epicatechin	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
Cmax of Epicatechin gallate	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
Tmax of Epigallocatechin	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
Tmax of Epicatechin gallate	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

Trial Locations

Locations (1)

Ohio State University; 🇺🇸 Columbus, Ohio, United States