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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT03413735
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Green Tea Extract — OTHER
    Confections containing green tea extract that will be ingested daily for 4 weeks
  • Placebo — OTHER
    Confections containing no green tea extract that will be ingested daily for 4 weeks

Study Details

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 examine the bioavailability of green tea catechins among lean and obese persons who consumed a single dose of a green tea extract (GTE)-containing confection. These persons will then complete phase 2, which consists of a parallel design randomized controlled in which lean and obese persons will consume placebo or GTE confections. 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.

Key Dates

Start date
Aug 29, 2018
Status verified
May 2025
Primary completion
Jul 30, 2019
Completion
Jul 30, 2019

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Placebo Confection
    Confection without green tea extract consumed daily for 4 weeks
  • Experimental: Green Tea Extract-Confection
    Confection with green tea extract consumed daily for 4 weeks

Primary Outcome Measure

Endotoxin [ Time Frame: Week 0 - Fasting ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State UniversityColumbusOhio43210-

Find similar trials in Columbus, OH

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Ohio State University· Columbus, OH

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