Status:
COMPLETED
Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults
Lead Sponsor:
Ohio State University
Conditions:
Obesity
Endotoxemia
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
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 ex...
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 inflammatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03413735
Start Date
August 29 2018
End Date
July 30 2019
Last Update
June 13 2025
Active Locations (1)
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1
Ohio State University
Columbus, Ohio, United States, 43210