Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome

Ohio State University46 enrolled

Overview

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.

Tea is the most abundantly consumed prepared beverage in the world. Green tea, containing catechins, exerts antiinflammatory activities. However, a fundamental gap exists concerning its intestinal-level targets that can prevent metabolic syndrome (MetS) development and progression. Studies in obese rodents indicate that green tea inhibits nuclear factor kappa-light-chain-enhancer of activated B cells (NFκB) activation by limiting gut-derived endotoxin translocation to the portal circulation and decreasing hepatic Toll-like receptor-4 (TLR4) pro-inflammatory signaling. The objective of this clinical investigation is to establish evidence-based recommendations for green tea, based on improvements in endotoxemia and restored gut barrier function, that promote optimal health. The hypothesis is that green tea catechins function to limit metabolic endotoxemia by ameliorating gut dysbiosis-mediated inflammation that otherwise provokes intestinal permeability. This will be tested by conducting a double-blind, placebo-controlled, randomized-order, crossover trial in MetS and healthy persons to examine the efficacy of green tea on metabolic endotoxemia. Each treatment will be one-month in duration and separated by a washout period. The anticipated outcomes are expected to be of significance, because they will advance a dietary strategy to help avert MetS complications attributed to metabolic endotoxemia by establishing antiinflammatory prebiotic and antimicrobial bioactivities of catechins that promote intestinal health.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Dysbiosis Endotoxemia Metabolic Syndrome Inflammation

Interventions

Green Tea ExtractDIETARY_SUPPLEMENT

A gummy confection with catechin-rich green tea extract (1 g/d)

PlaceboDIETARY_SUPPLEMENT

A matched gummy confection formulated without green tea extract

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: Individuals with ≥3 of the following established criteria for metabolic syndrome: * Fasting glucose 100-126 mg/dL * Waist circumference \>89/\>102 cm for females/males * HDL-C \<50/\<40 mg/dL for females/males * Triglyceride \>150 mg/dL * Blood pressure \>130/85 mmHg Healthy adults: * Body weight 19-25 kg/m2 * Fasting glucose \<100 mg/dL * HDL-C \>50/\>40 mg/dL for females/males * Triglyceride \<150 mg/dL * Blood pressure \<120/80 mmHg Exclusion criteria: * Concurrent tea consumption * Use of dietary supplements, prebiotics, or probiotics * Use of antibiotics or antiinflammatory agents * History of liver disease, cardiovascular disease, hypertension (blood pressure \>140/90 mmHg), or cancer * History of gastrointestinal disorders, chronic diarrhea, or surgeries * Hemochromatosis * Parkinson's disease * Use of medications to manage diabetes, hypertension, or hyperlipidemia * Use of antipsychotic medications \[Clozapine, lithium, Diazepam\] * Use of blood thinning medications \[Warfarin\] * Use of high blood pressure medications \[nadolol\] * Use of monoamine oxidase inhibitors \[selegiline\] * Alcohol consumption \>2 drinks/d * Smoking tobacco * Vegetarian * Pregnancy, lactation, or recent changes in birth control use for women

Locations (1)

The Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Serum Endotoxin

Data are biomarker fasting concentrations.

Time frame: Day 28

Secondary Outcomes

Plasma Lipopolysaccharide-binding Protein

Data are biomarker fasting concentrations

Time frame: Day 28

Urinary Lactulose/Mannitol Ratio

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

Time frame: Day 28

Urinary Sucralose/Erythritol Ratio

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

Time frame: Day 28

Plasma Interleukin-6

Data are biomarker concentrations at fasting

Time frame: Day 28

Fecal Calprotectin

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

Time frame: Day 25-27 (pooled samples) of the 28-day intervention

Fecal Myeloperoxidase

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

Time frame: Day 25-27 (pooled samples) of the 28-day intervention

Plasma Epigallocatechin Gallate

Data are plasma concentrations of epigallocatechin gallate

Data from ClinicalTrials.gov

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