Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Infectious Disease |
| Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 2/2/2019 |
| Start Date: | August 29, 2018 |
| End Date: | December 31, 2019 |
| Contact: | Richard Bruno, PhD, RD |
| Email: | bruno.27@osu.edu |
| Phone: | 6142925522 |
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.
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.
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.
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.
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
We found this trial at
1
site
281 W. Lane Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Richard Bruno, PhD, RD
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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