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

NCT03413735 | Completed Results

• 1 other identifier: 2017H0246
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Obesity; Endotoxemia; Inflammation

Outcome Measures

Primary Outcomes (3)

• Endotoxin

  Serum endotoxin concentration

  Week 0 - Fasting

• Endotoxin

  Serum endotoxin concentration

  Week 2 - Fasting

• Endotoxin

  Serum endotoxin concentration

  Week 4 - Fasting

Secondary Outcomes (24)

• Gut Permeability - Lactulose to Mannitol Ratio

  Week 0 - 0-5 hours

• Gut Permeability - Lactulose to Mannitol Ratio

  Week 0 - 6-24 hours

• Gut Permeability - Lactulose to Mannitol Ratio

  Week 4 - 0-5 hours

• Gut Permeability - Lactulose to Mannitol Ratio

  Week 4 - 6-24 hours

• Gut Permeability - Sucralose to Erythritol Ratio

  Week 0 - 6-24 hours

Study Arms (2)

Placebo Confection

PLACEBO COMPARATOR

Confection without green tea extract consumed daily for 4 weeks

Other: Placebo

Green Tea Extract-Confection

EXPERIMENTAL

Confection with green tea extract consumed daily for 4 weeks

Other: Green Tea Extract

Interventions

Green Tea Extract OTHER

Confections containing green tea extract that will be ingested daily for 4 weeks

Green Tea Extract-Confection

Placebo OTHER

Confections containing no green tea extract that will be ingested daily for 4 weeks

Placebo Confection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Overweight/obese (BMI = 28-40 kg/m2)
• Fasting glucose \< 126 mg/dL
• Normotensive (blood pressure \< 140/90 mmHg)
• Non-dietary supplement user
• Non-smoker

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• Li J, Sapper TN, Mah E, Moller MV, Kim JB, Chitchumroonchokchai C, McDonald JD, Bruno RS. Green tea extract treatment reduces NFkappaB activation in mice with diet-induced nonalcoholic steatohepatitis by lowering TNFR1 and TLR4 expression and ligand availability. J Nutr Biochem. 2017 Mar;41:34-41. doi: 10.1016/j.jnutbio.2016.12.007. Epub 2016 Dec 21.

  PMID: 28038359 BACKGROUND

• Li J, Sasaki GY, Dey P, Chitchumroonchokchai C, Labyk AN, McDonald JD, Kim JB, Bruno RS. Green tea extract protects against hepatic NFkappaB activation along the gut-liver axis in diet-induced obese mice with nonalcoholic steatohepatitis by reducing endotoxin and TLR4/MyD88 signaling. J Nutr Biochem. 2018 Mar;53:58-65. doi: 10.1016/j.jnutbio.2017.10.016. Epub 2017 Nov 3.

  PMID: 29190550 BACKGROUND

MeSH Terms

Conditions

Obesity; Endotoxemia; Inflammation

Interventions

Tea

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Pathologic Processes

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr. Richard Bruno
• Organization: The Ohio State University

bruno.27@osu.edu

614-292-5522

Study Officials

• Richard Bruno, PhD, RD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 29, 2018
• Study Start: August 29, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)