Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03413735
Recruitment Status : Active, not recruiting
First Posted : January 29, 2018
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Richard Bruno, 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.

Condition or disease Intervention/treatment Phase
Obesity Endotoxemia Inflammation Other: Green Tea Extract Other: Placebo Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults
Actual Study Start Date : August 29, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Confection
Confection without green tea extract consumed daily for 4 weeks
Other: Placebo
Confections containing no green tea extract that will be ingested daily for 4 weeks

Experimental: Green Tea Extract-Confection
Confection with green tea extract consumed daily for 4 weeks
Other: Green Tea Extract
Confections containing green tea extract that will be ingested daily for 4 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  1. Gut Permeability - Lactulose to Mannitol Ratio [ Time Frame: Week 0 - 0-5 hours ]
    Ratio of excretion of urinary sugars

  2. Gut Permeability - Lactulose to Mannitol Ratio [ Time Frame: Week 0 - 6-24 hours ]
    Ratio of excretion of urinary sugars

  3. Gut Permeability - Lactulose to Mannitol Ratio [ Time Frame: Week 4 - 0-5 hours ]
    Ratio of excretion of urinary sugars

  4. Gut Permeability - Lactulose to Mannitol Ratio [ Time Frame: Week 4 - 6-24 hours ]
    Ratio of excretion of urinary sugars

  5. Gut Permeability - Sucralose to Erythritol Ratio [ Time Frame: Week 0 - 0-5 hours ]
    Ratio of excretion of urinary sugars

  6. Gut Permeability - Sucralose to Erythritol Ratio [ Time Frame: Week 0 - 6-24 hours ]
    Ratio of excretion of urinary sugars

  7. Gut Permeability - Sucralose to Erythritol Ratio [ Time Frame: Week 4 - 0-5 hours ]
    Ratio of excretion of urinary sugars

  8. Gut Permeability - Sucralose to Erythritol Ratio [ Time Frame: Week 4 - 6-24 hours ]
    Ratio of excretion of urinary sugars

  9. Firmicutes to Bacteroidetes Ratio - Microbiota [ Time Frame: Week 0 ]
    Ratio of relative abundances of Firmicutes to Bacteroidetes in feces

  10. Firmicutes to Bacteroidetes Ratio - Microbiota [ Time Frame: Week 4 ]
    Ratio of relative abundances of Firmicutes to Bacteroidetes in feces

  11. Bioavailability - Epigallocatechin gallate [ Time Frame: 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

  12. Bioavailability - Epigallocatechin [ Time Frame: 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

  13. Bioavailability - Epicatechin gallate [ Time Frame: 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

  14. Bioavailability - Epicatechin [ Time Frame: 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

  15. Cmax of Epigallocatechin gallate [ Time Frame: 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: 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: 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: 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: 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: 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: 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: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413735


Locations
Layout table for location information
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Layout table for investigator information
Principal Investigator: Richard Bruno, PhD, RD Ohio State University
Publications:
Layout table for additonal information
Responsible Party: Richard Bruno, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03413735    
Other Study ID Numbers: 2017H0246
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be published as aggregate only. Data sharing may be possible pending institutional agreements.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Endotoxemia
Inflammation
Pathologic Processes
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome