Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome (NCT03973996) | Clinical Trial Compass
CompletedNot Applicable
Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome
United States46 participantsStarted 2019-07-01
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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