NCT03973996

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

December 2, 2025

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

May 30, 2019

Results QC Date

July 13, 2025

Last Update Submit

December 3, 2025

Conditions

DysbiosisEndotoxemiaMetabolic SyndromeInflammation

Keywords

Green teaGut barrier functionGut dysbiosisInflammationMetabolic endotoxemiaMetabolic syndromeMicrobiome

Outcome Measures

Primary Outcomes (1)

  • Serum Endotoxin

    Data are biomarker fasting concentrations.

    Day 28

Secondary Outcomes (29)

  • Plasma Lipopolysaccharide-binding Protein

    Day 28

  • Urinary Lactulose/Mannitol Ratio

    Day 28

  • Urinary Sucralose/Erythritol Ratio

    Day 28

  • Plasma Interleukin-6

    Day 28

  • Fecal Calprotectin

    Day 25-27 (pooled samples) of the 28-day intervention

  • +24 more secondary outcomes

Study Arms (2)

Green Tea

EXPERIMENTAL

Participants consuming gummy confections with catechin-rich green tea extract daily for 4 weeks

Dietary Supplement: Green Tea Extract

Placebo

PLACEBO COMPARATOR

Participants consuming matched gummy confections formulated without green tea extract daily for 4 weeks

Dietary Supplement: Placebo

Interventions

Green Tea ExtractDIETARY_SUPPLEMENT

A gummy confection with catechin-rich green tea extract (1 g/d)

Also known as: Camellia sinesis plant extract
Green Tea
PlaceboDIETARY_SUPPLEMENT

A matched gummy confection formulated without green tea extract

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (4)

  • Dey P, Sasaki GY, Wei P, Li J, Wang L, Zhu J, McTigue D, Yu Z, Bruno RS. Green tea extract prevents obesity in male mice by alleviating gut dysbiosis in association with improved intestinal barrier function that limits endotoxin translocation and adipose inflammation. J Nutr Biochem. 2019 May;67:78-89. doi: 10.1016/j.jnutbio.2019.01.017. Epub 2019 Feb 8.

    PMID: 30856467BACKGROUND

  • 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: 29190550BACKGROUND

  • Hodges JK, Zhu J, Yu Z, Vodovotz Y, Brock G, Sasaki GY, Dey P, Bruno RS. Intestinal-level anti-inflammatory bioactivities of catechin-rich green tea: Rationale, design, and methods of a double-blind, randomized, placebo-controlled crossover trial in metabolic syndrome and healthy adults. Contemp Clin Trials Commun. 2019 Nov 20;17:100495. doi: 10.1016/j.conctc.2019.100495. eCollection 2020 Mar.

    PMID: 31799477BACKGROUND

  • Zeng M, Hodges JK, Pokala A, Khalafi M, Sasaki GY, Pierson J, Cao S, Brock G, Yu Z, Zhu J, Vodovotz Y, Bruno RS. A green tea extract confection decreases circulating endotoxin and fasting glucose by improving gut barrier function but without affecting systemic inflammation: A double-blind, placebo-controlled randomized trial in healthy adults and adults with metabolic syndrome. Nutr Res. 2024 Apr;124:94-110. doi: 10.1016/j.nutres.2024.02.001. Epub 2024 Feb 5.

    PMID: 38430822RESULT

MeSH Terms

Conditions

DysbiosisEndotoxemiaMetabolic SyndromeInflammation

Interventions

Tea

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBacteremiaSepsisInfectionsToxemiaSystemic Inflammatory Response SyndromeInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Dr. Richard Bruno
Organization
Ohio State University
bruno.27@osu.edu
8603358494

Study Officials

  • Richard S 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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 30, 2019

First Posted

June 4, 2019

Study Start

July 1, 2019

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

December 19, 2025

Results First Posted

December 2, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)