The Ohio State University
Columbus, Ohio, 43210, United States
NCT Number: NCT03973996
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Columbus, Ohio, 43210, United States
Tea is the most abundantly consumed prepared beverage in the world. Green tea, containing catechins, exerts antiinflammatory activities. However, a fundamental gap exists concerning its intestinal-level targets that can prevent metabolic syndrome (MetS) development and progression. Studies in obese rodents indicate that green tea inhibits nuclear factor kappa-light-chain-enhancer of activated B cells (NFκB) activation by limiting gut-derived endotoxin translocation to the portal circulation and decreasing hepatic Toll-like receptor-4 (TLR4) pro-inflammatory signaling. The objective of this clinical investigation is to establish evidence-based recommendations for green tea, based on improvements in endotoxemia and restored gut barrier function, that promote optimal health. The hypothesis is that green tea catechins function to limit metabolic endotoxemia by ameliorating gut dysbiosis-mediated inflammation that otherwise provokes intestinal permeability. This will be tested by conducting a double-blind, placebo-controlled, randomized-order, crossover trial in MetS and healthy persons to examine the efficacy of green tea on metabolic endotoxemia. Each treatment will be one-month in duration and separated by a washout period. The anticipated outcomes are expected to be of significance, because they will advance a dietary strategy to help avert MetS complications attributed to metabolic endotoxemia by establishing antiinflammatory prebiotic and antimicrobial bioactivities of catechins that promote intestinal health.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Individuals with ≥3 of the following established criteria for metabolic syndrome:
Healthy adults:
Exclusion criteria
A gummy confection with catechin-rich green tea extract (1 g/d)
Other names: Camellia sinesis plant extract
A matched gummy confection formulated without green tea extract
Time frame: Day 28
Data are biomarker fasting concentrations.
Time frame: Day 28
Data are biomarker fasting concentrations
Time frame: Day 28
Lactulose/mannitol ratio in urine collected 0-5 h post-ingestion of non-digestible sugar probes.
Time frame: Day 28
Sucralose/Erythritol ratio measured in urine collected 0-24 h post-ingestion of non-digestible sugar probes
Time frame: Day 28
Data are biomarker concentrations at fasting
Time frame: Day 25-27 (pooled samples) of the 28-day intervention
Data are biomarker fecal concentrations, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Time frame: Day 25-27 (pooled samples) of the 28-day intervention
Data are biomarker fecal concentrations, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Time frame: Day 28
Data are plasma concentrations of epigallocatechin gallate
Time frame: Day 28
Data are plasma concentrations of epicatechin.
Time frame: Day 28
Data are plasma concentrations of epicatechin gallate.
Time frame: Day 28
Data are biomarker concentrations at fasting
Time frame: Day 28
Data are biomarker concentrations at fasting
Time frame: Day 28
Data are biomarker concentrations at fasting
Time frame: Day 28
Data are biomarker concentrations at fasting
Time frame: Day 28
Data are biomarker concentrations at fasting
Time frame: Day 28
Data are biomarker concentrations at fasting
Time frame: Day 28
Data are biomarker concentrations at fasting
Time frame: Day 28
Data are biomarker concentrations at fasting
Time frame: Day 28
Data are biomarker concentrations at fasting
Time frame: Day 28
Data are biomarker concentrations at fasting
Time frame: Day 28
Data are biomarker fasting concentrations
Time frame: Days 25-27 (pooled samples) of the 28-day intervention
Data are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Time frame: Days 25-27 (pooled samples) of the 28-day intervention
Data are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Time frame: Day 25-27 (pooled samples) from the 28-day intervention
Data are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Time frame: Day 25-27 (pooled samples) from the 28-day intervention
Data are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Time frame: Day 25-27 (pooled samples) from the 28-day intervention
Data are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Time frame: Day 25-27 (pooled samples) of the 28-day intervention
Data are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Time frame: Day 25-27 (pooled samples) of the 28-day intervention
Data are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Time frame: Day 28
Data are biomarker fasting concentrations
Time frame: Day 28
Data are biomarker fasting concentrations
Ohio State University
Other
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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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