Skip to main content
OpenTrials
Completed

NCT Number: NCT03973996

Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Green Tea Extract

Dietary Supplement

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

Other names: Camellia sinesis plant extract

Placebo

Dietary Supplement

A matched gummy confection formulated without green tea extract

Primary outcomes

  1. Serum Endotoxin

    Time frame: Day 28

    Data are biomarker fasting concentrations.

Secondary outcomes

  1. Plasma Lipopolysaccharide-binding Protein

    Time frame: Day 28

    Data are biomarker fasting concentrations

  2. Urinary Lactulose/Mannitol Ratio

    Time frame: Day 28

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

  3. Urinary Sucralose/Erythritol Ratio

    Time frame: Day 28

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

  4. Plasma Interleukin-6

    Time frame: Day 28

    Data are biomarker concentrations at fasting

  5. Fecal Calprotectin

    Time frame: 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.

  6. Fecal Myeloperoxidase

    Time frame: 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.

  7. Plasma Epigallocatechin Gallate

    Time frame: Day 28

    Data are plasma concentrations of epigallocatechin gallate

  8. Plasma Epicatechin

    Time frame: Day 28

    Data are plasma concentrations of epicatechin.

  9. Plasma Epicatechin Gallate

    Time frame: Day 28

    Data are plasma concentrations of epicatechin gallate.

  10. Plasma 3,4-γ-valerolactone

    Time frame: Day 28

    Data are biomarker concentrations at fasting

  11. Plasma 3,4,5-γ-Valerolactone

    Time frame: Day 28

    Data are biomarker concentrations at fasting

  12. Plasma Soluble Cluster of Differentiation-14

    Time frame: Day 28

    Data are biomarker concentrations at fasting

  13. Plasma Glucose

    Time frame: Day 28

    Data are biomarker concentrations at fasting

  14. Plasma Insulin

    Time frame: Day 28

    Data are biomarker concentrations at fasting

  15. Plasma Triglyceride

    Time frame: Day 28

    Data are biomarker concentrations at fasting

  16. Plasma Total Cholesterol

    Time frame: Day 28

    Data are biomarker concentrations at fasting

  17. Serum Alanine Transaminase

    Time frame: Day 28

    Data are biomarker concentrations at fasting

  18. Serum Aspartate Transaminase

    Time frame: Day 28

    Data are biomarker concentrations at fasting

  19. Blood Hematocrit

    Time frame: Day 28

    Data are biomarker concentrations at fasting

  20. Plasma Tumor Necrosis Factor-alpha

    Time frame: Day 28

    Data are biomarker fasting concentrations

  21. Fecal Butyrate

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

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

  22. Fecal Acetate

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

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

  23. Fecal Valeric Acid

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

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

  24. Fecal Hexanoic Acid

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

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

  25. Fecal Isobutyric Acid

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

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

  26. Fecal 2-Methylbutyric

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

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

  27. Fecal Isovaleric Acid

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

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

  28. Plasma Ascorbic Acid

    Time frame: Day 28

    Data are biomarker fasting concentrations

  29. Plasma Uric Acid

    Time frame: Day 28

    Data are biomarker fasting concentrations

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • United States Department of Agriculture (USDA)

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2019
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.