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Completed

NCT Number: NCT03413735

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University

Columbus, Ohio, 43210, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

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

Treatment and study plan

green tea extract

Other

Confections containing green tea extract that will be ingested daily for 4 weeks

Placebo

Other

Confections containing no green tea extract that will be ingested daily for 4 weeks

Primary outcomes

  1. Endotoxin

    Time frame: Week 0 - Fasting

    Serum endotoxin concentration

  2. Endotoxin

    Time frame: Week 2 - Fasting

    Serum endotoxin concentration

  3. Endotoxin

    Time frame: Week 4 - Fasting

    Serum endotoxin concentration

Secondary outcomes

  1. Gut Permeability - Lactulose to Mannitol Ratio

    Time frame: Week 0 - 0-5 hours

    Urinary Lactulose/Mannitol Ratio (mg/mg)

  2. Gut Permeability - Lactulose to Mannitol Ratio

    Time frame: Week 0 - 6-24 hours

    Urinary Lactulose/Mannitol Ratio (mg/mg)

  3. Gut Permeability - Lactulose to Mannitol Ratio

    Time frame: Week 4 - 0-5 hours

    Urinary Lactulose/Mannitol Ratio (mg/mg)

  4. Gut Permeability - Lactulose to Mannitol Ratio

    Time frame: Week 4 - 6-24 hours

    Urinary Lactulose/Mannitol Ratio (mg/mg)

  5. Gut Permeability - Sucralose to Erythritol Ratio

    Time frame: Week 0 - 6-24 hours

    Urinary Sucralose/Erythritol Ratio (mg/mg)

  6. Gut Permeability - Sucralose to Erythritol Ratio

    Time frame: Week 0 - 0-24 hours

    Urinary Sucralose/Erythritol Ratio (mg/mg)

  7. Urinary Sucralose/Erythritol Ratio (mg/mg)

    Time frame: Week 4 - 6-24 hours

    Ratio of excretion of urinary sugars (Sucralose to Erythritol)

  8. Gut Permeability - Sucralose to Erythritol Ratio

    Time frame: Week 4 - 0-24 hours

    Urinary Sucralose/Erythritol Ratio (mg/mg)

  9. Firmicutes to Bacteroidetes Ratio - Microbiota

    Time frame: Week 0

    Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)

  10. Firmicutes to Bacteroidetes Ratio - Microbiota

    Time frame: Week 4

    Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)

  11. Bioavailability - Epigallocatechin Gallate

    Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection

    Area under the curve (AUC) of plasma epigallocatechin calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epigallocatechin gallate is measured in umol/L over time (hours) resulting in the AUC.

  12. Bioavailability - Epigallocatechin

    Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection

    Area under the curve (AUC) of plasma epigallocatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epigallocatechin is measured in umol/L over time (hours) resulting in the AUC.

  13. Bioavailability - Epicatechin Gallate

    Time frame: Prior to the intervention enrollment...0-12 hours post-ingestion of a green tea confection

    Area under the curve (AUC) of plasma epicatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epicatechins is measured in umol/L over time (hours) resulting in the AUC.

  14. Bioavailability - Epicatechin

    Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection

    Area under the curve (AUC) of plasma epicatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epicatechin is measured in umol/L over time (hours) resulting in the AUC.

  15. Cmax of Epigallocatechin Gallate

    Time frame: Prior to intervention enrollment...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

  16. Cmax of Epigallocatechin

    Time frame: Prior to intervention enrollment...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

  17. Cmax of Epicatechin Gallate

    Time frame: Prior to intervention enrollment...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

  18. Cmax of Epicatechin

    Time frame: Prior to intervention enrollment...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

  19. Tmax of Epigallocatechin Gallate

    Time frame: Prior to intervention enrollment...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

  20. Tmax of Epigallocatechin

    Time frame: Prior to intervention enrollment...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

  21. Tmax of Epicatechin Gallate

    Time frame: Prior to intervention enrollment...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

  22. Tmax of Epicatechin

    Time frame: Prior to intervention enrollment...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

  23. Calprotectin

    Time frame: Week 0

    Fecal calprotectin concentration

  24. Calprotectin

    Time frame: Week 4

    Fecal calprotectin concentration

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 29, 2018
Registry last updated
Jun 13, 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.

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