N/A N=46 Randomized Double-blind Prevention

Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome

Dysbiosis · Endotoxemia · Metabolic Syndrome · Inflammation

Bottom Line

View on ClinicalTrials.gov: NCT03973996 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2025

Primary outcome: Primary: Serum Endotoxin — 31.6; 26.7; 44.5; 39.1 EU/mL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Green Tea Extract (Dietary_supplement); Placebo (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ohio State University
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Endotoxin	31.6; 26.7; 44.5; 39.1	—
SECONDARY Plasma Lipopolysaccharide-binding Protein	4035; 4435; 7890; 8572	—
SECONDARY Urinary Lactulose/Mannitol Ratio	0.075; 0.084; 0.087; 0.065	—
SECONDARY Urinary Sucralose/Erythritol Ratio	0.014; 0.014; 0.015; 0.015	—
SECONDARY Plasma Interleukin-6	1.9; 1.9; 3.1; 3.3	—
SECONDARY Fecal Calprotectin	35.9; 24.4; 42.5; 36.7	—
SECONDARY Fecal Myeloperoxidase	97.4; 83.4; 148.1; 97.9	—
SECONDARY Plasma Epigallocatechin Gallate	0.001; 0.343; 0.00; 0.21	—
SECONDARY Plasma Epicatechin	0.0; 0.022; 0.00016; 0.015	—
SECONDARY Plasma Epicatechin Gallate	0.002; 0.30; 0.002; 0.20	—
SECONDARY Plasma 3,4-γ-valerolactone	0.008; 0.17; 0.007; 0.090	—
SECONDARY Plasma 3,4,5-γ-Valerolactone	0.001; 0.034; 0.0017; 0.0060	—
SECONDARY Plasma Soluble Cluster of Differentiation-14	1465; 1459; 1424; 1367	—
SECONDARY Plasma Glucose	86.3; 83.9; 98.9; 98.6	—
SECONDARY Plasma Insulin	6.4; 6.0; 19.6; 22.4	—
SECONDARY Plasma Triglyceride	51.2; 54.7; 140.5; 149.9	—
SECONDARY Plasma Total Cholesterol	195.5; 186.9; 220.1; 215.6	—
SECONDARY Serum Alanine Transaminase	15.0; 15.0; 24.2; 23.6	—
SECONDARY Serum Aspartate Transaminase	17.3; 17.5; 19.5; 20.2	—
SECONDARY Blood Hematocrit	44.3; 45.1; 44.0; 43.5	—
SECONDARY Plasma Tumor Necrosis Factor-alpha	1.2; 2.3; 4.8; 5.0	—
SECONDARY Fecal Butyrate	11.7; 10.8; 16.6; 13.9	—
SECONDARY Fecal Acetate	35.9; 33.1; 47.9; 41.9	—
SECONDARY Fecal Valeric Acid	0.95; 0.91; 2.04; 1.86	—
SECONDARY Fecal Hexanoic Acid	0.56; 0.49; 0.98; 0.55	—
SECONDARY Fecal Isobutyric Acid	1.86; 1.67; 1.87; 1.87	—
SECONDARY Fecal 2-Methylbutyric	1.29; 1.14; 1.20; 1.20	—
SECONDARY Fecal Isovaleric Acid	1.40; 1.22; 1.38; 1.40	—
SECONDARY Plasma Ascorbic Acid	40.2; 41.6; 32.1; 28.6	—
SECONDARY Plasma Uric Acid	244.7; 256.0; 330.3; 319.8	—

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.

Eligibility Criteria

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 150 mg/dL
Blood pressure >130/85 mmHg

Healthy adults:

Body weight 19-25 kg/m2
Fasting glucose 50/>40 mg/dL for females/males
Triglyceride 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03973996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.