CompletedNCT03973996Updated Dec 19, 2025Results posted

Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome

An interventional study of Green Tea Extract and Placebo in Dysbiosis, Endotoxemia and Metabolic Syndrome, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Ohio State University · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 46
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the detailed description

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.

Conditions studied

Dysbiosis
Endotoxemia
Metabolic Syndrome
Inflammation

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Keywords

Green tea
Gut barrier function
Gut dysbiosis
Inflammation
Metabolic endotoxemia
Metabolic syndrome
Microbiome

In context

Dysbiosis

187 studies on the registry are indexed under Dysbiosis; 64 are open to participants now.

This study's enrollment of 46 is below the median of 60 across 132 interventional studies indexed under Dysbiosis.

Browse Dysbiosis studies →

Lead sponsor

Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.

Browse Ohio State University studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 \<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

Exclusion criteria

Exclusion criteria:

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
Pregnancy, lactation, or recent changes in use for women

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 46 participants (actual)

Study arms

Experimental
Green Tea
Participants consuming gummy confections with catechin-rich green tea extract daily for 4 weeks
Dietary Supplement: Green Tea Extract
Placebo comparator
Placebo
Participants consuming matched gummy confections formulated without green tea extract daily for 4 weeks
Dietary Supplement: Placebo

Interventions

Dietary supplementGreen Tea Extract
A gummy confection with catechin-rich green tea extract (1 g/d)
Also known as: Camellia sinesis plant extract
Dietary supplementPlacebo
A matched gummy confection formulated without green tea extract

What researchers measure

Primary outcomes

Serum Endotoxin
Data are biomarker fasting concentrations.
Time frame: Day 28

Secondary outcomes

Plasma Lipopolysaccharide-binding Protein
Data are biomarker fasting concentrations
Time frame: Day 28
Urinary Lactulose/Mannitol Ratio
Lactulose/mannitol ratio in urine collected 0-5 h post-ingestion of non-digestible sugar probes.
Time frame: Day 28
Urinary Sucralose/Erythritol Ratio
Sucralose/Erythritol ratio measured in urine collected 0-24 h post-ingestion of non-digestible sugar probes
Time frame: Day 28
Plasma Interleukin-6
Data are biomarker concentrations at fasting
Time frame: Day 28
Fecal Calprotectin
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
Fecal Myeloperoxidase
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
Plasma Epigallocatechin Gallate
Data are plasma concentrations of epigallocatechin gallate
Time frame: Day 28
Plasma Epicatechin
Data are plasma concentrations of epicatechin.
Time frame: Day 28
Plasma Epicatechin Gallate
Data are plasma concentrations of epicatechin gallate.
Time frame: Day 28
Plasma 3,4-γ-valerolactone
Data are biomarker concentrations at fasting
Time frame: Day 28
Plasma 3,4,5-γ-Valerolactone
Data are biomarker concentrations at fasting
Time frame: Day 28
Plasma Soluble Cluster of Differentiation-14
Data are biomarker concentrations at fasting
Time frame: Day 28
Plasma Glucose
Data are biomarker concentrations at fasting
Time frame: Day 28
Plasma Insulin
Data are biomarker concentrations at fasting
Time frame: Day 28
Plasma Triglyceride
Data are biomarker concentrations at fasting
Time frame: Day 28
Plasma Total Cholesterol
Data are biomarker concentrations at fasting
Time frame: Day 28
Serum Alanine Transaminase
Data are biomarker concentrations at fasting
Time frame: Day 28
Serum Aspartate Transaminase
Data are biomarker concentrations at fasting
Time frame: Day 28
Blood Hematocrit
Data are biomarker concentrations at fasting
Time frame: Day 28
Plasma Tumor Necrosis Factor-alpha
Data are biomarker fasting concentrations
Time frame: Day 28
Fecal Butyrate
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
Fecal Acetate
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
Fecal Valeric Acid
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
Fecal Hexanoic Acid
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
Fecal Isobutyric Acid
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
Fecal 2-Methylbutyric
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
Fecal Isovaleric Acid
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
Plasma Ascorbic Acid
Data are biomarker fasting concentrations
Time frame: Day 28
Plasma Uric Acid
Data are biomarker fasting concentrations
Time frame: Day 28

Results

Posted Dec 2, 2025

Participant flow

First Intervention (4 Weeks)

Participant flow — First Intervention (4 Weeks)
Milestone	Healthy - Placebo Then GTE	MetS - GTE Then Placebo	Healthy- GTE Then Placebo	MetS - Placebo Then GTE
Started	10	12	11	13
Completed	9	11	10	10
Not completed	1	1	1	3
Withdrew: Withdrawal by subject	1	1	1	3

Washout (4 Weeks)

Participant flow — Washout (4 Weeks)
Milestone	Healthy - Placebo Then GTE	MetS - GTE Then Placebo	Healthy- GTE Then Placebo	MetS - Placebo Then GTE
Started	9	11	10	10
Completed	9	11	10	10
Not completed	0	0	0	0

Second Intervention (4 Weeks)

Participant flow — Second Intervention (4 Weeks)
Milestone	Healthy - Placebo Then GTE	MetS - GTE Then Placebo	Healthy- GTE Then Placebo	MetS - Placebo Then GTE
Started	9	11	10	10
Completed	9	11	10	10
Not completed	0	0	0	0

Outcome measures

PrimarySerum Endotoxin

Data are biomarker fasting concentrations.

Time frame:: Day 28
Reported as:: Mean · EU/mL

Serum Endotoxin
EU/mL	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Serum Endotoxin	31.6 ± 2.5	26.7 ± 2.6	44.5 ± 2.4	39.1 ± 2.5

SecondaryPlasma Lipopolysaccharide-binding Protein

Data are biomarker fasting concentrations

Time frame:: Day 28
Reported as:: Mean · ng/mL

Plasma Lipopolysaccharide-binding Protein
ng/mL	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Plasma Lipopolysaccharide-binding Protein	4035 ± 339	4435 ± 380	7890 ± 1143	8572 ± 1394

SecondaryUrinary Lactulose/Mannitol Ratio

Lactulose/mannitol ratio in urine collected 0-5 h post-ingestion of non-digestible sugar probes.

Time frame:: Day 28
Reported as:: Mean · ratio

Urinary Lactulose/Mannitol Ratio
ratio	Healthy - GTE	Healthy - Placebo	MetS - Placebo	MetS - GTE
Urinary Lactulose/Mannitol Ratio	0.075 ± 0.009	0.084 ± 0.012	0.087 ± 0.013	0.065 ± 0.007

SecondaryUrinary Sucralose/Erythritol Ratio

Sucralose/Erythritol ratio measured in urine collected 0-24 h post-ingestion of non-digestible sugar probes

Time frame:: Day 28
Reported as:: Mean · ratio

Urinary Sucralose/Erythritol Ratio
ratio	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Urinary Sucralose/Erythritol Ratio	0.014 ± 0.0014	0.014 ± 0.0015	0.015 ± 0.001	0.015 ± 0.001

SecondaryPlasma Interleukin-6

Data are biomarker concentrations at fasting

Time frame:: Day 28
Reported as:: Mean · pg/mL

Plasma Interleukin-6
pg/mL	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Plasma Interleukin-6	1.9 ± 0.085	1.9 ± 0.070	3.1 ± 0.24	3.3 ± 0.29

SecondaryFecal Calprotectin

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
Reported as:: Mean · ug/g

Fecal Calprotectin
ug/g	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Fecal Calprotectin	35.9 ± 5.5	24.4 ± 2.7	42.5 ± 9.3	36.7 ± 5.2

SecondaryFecal Myeloperoxidase

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
Reported as:: Mean · ng/g

Fecal Myeloperoxidase
ng/g	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Fecal Myeloperoxidase	97.4 ± 9.9	83.4 ± 7.5	148.1 ± 40.9	97.9 ± 10.5

SecondaryPlasma Epigallocatechin Gallate

Data are plasma concentrations of epigallocatechin gallate

Time frame:: Day 28
Reported as:: Mean · umol/L

Plasma Epigallocatechin Gallate
umol/L	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Plasma Epigallocatechin Gallate	0.001 ± 0.001	0.343 ± 0.057	0.00 ± 0.00	0.21 ± 0.04

SecondaryPlasma Epicatechin

Data are plasma concentrations of epicatechin.

Time frame:: Day 28
Reported as:: Mean · umol/L

Plasma Epicatechin
umol/L	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Plasma Epicatechin	0.0 ± 0.0	0.022 ± 0.0048	0.00016 ± 0.00016	0.015 ± 0.003

SecondaryPlasma Epicatechin Gallate

Data are plasma concentrations of epicatechin gallate.

Time frame:: Day 28
Reported as:: Mean · umol/L

Plasma Epicatechin Gallate
umol/L	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Plasma Epicatechin Gallate	0.002 ± 0.001	0.30 ± 0.037	0.002 ± 0.001	0.20 ± 0.027

SecondaryPlasma 3,4-γ-valerolactone

Data are biomarker concentrations at fasting

Time frame:: Day 28
Reported as:: Mean · umol/L

Plasma 3,4-γ-valerolactone
umol/L	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Plasma 3,4-γ-valerolactone	0.008 ± 0.005	0.17 ± 0.050	0.007 ± 0.003	0.090 ± 0.031

SecondaryPlasma 3,4,5-γ-Valerolactone

Data are biomarker concentrations at fasting

Time frame:: Day 28
Reported as:: Mean · umol/L

Plasma 3,4,5-γ-Valerolactone
umol/L	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Plasma 3,4,5-γ-Valerolactone	0.001 ± 0.001	0.034 ± 0.017	0.0017 ± 0.0010	0.0060 ± 0.0047

SecondaryPlasma Soluble Cluster of Differentiation-14

Data are biomarker concentrations at fasting

Time frame:: Day 28
Reported as:: Mean · ng/mL

Plasma Soluble Cluster of Differentiation-14
ng/mL	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Plasma Soluble Cluster of Differentiation-14	1465 ± 57	1459 ± 71	1424 ± 67	1367 ± 83

SecondaryPlasma Glucose

Data are biomarker concentrations at fasting

Time frame:: Day 28
Reported as:: Mean · mg/dL

Plasma Glucose
mg/dL	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Plasma Glucose	86.3 ± 1.6	83.9 ± 1.5	98.9 ± 3.0	98.6 ± 2.6

SecondaryPlasma Insulin

Data are biomarker concentrations at fasting

Time frame:: Day 28
Reported as:: Mean · μIU/mL

Plasma Insulin
μIU/mL	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Plasma Insulin	6.4 ± 0.7	6.0 ± 0.6	19.6 ± 2.3	22.4 ± 3.8

SecondaryPlasma Triglyceride

Data are biomarker concentrations at fasting

Time frame:: Day 28
Reported as:: Mean · mg/dL

Plasma Triglyceride
mg/dL	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Plasma Triglyceride	51.2 ± 4.1	54.7 ± 4.9	140.5 ± 14.0	149.9 ± 17.0

SecondaryPlasma Total Cholesterol

Data are biomarker concentrations at fasting

Time frame:: Day 28
Reported as:: Mean · mg/dL

Plasma Total Cholesterol
mg/dL	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Plasma Total Cholesterol	195.5 ± 9.4	186.9 ± 6.7	220.1 ± 9.0	215.6 ± 10.2

SecondarySerum Alanine Transaminase

Data are biomarker concentrations at fasting

Time frame:: Day 28
Reported as:: Mean · (U/L)

Serum Alanine Transaminase
(U/L)	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Serum Alanine Transaminase	15.0 ± 0.9	15.0 ± 1.0	24.2 ± 2.1	23.6 ± 2.3

SecondarySerum Aspartate Transaminase

Data are biomarker concentrations at fasting

Time frame:: Day 28
Reported as:: Mean · U/L

Serum Aspartate Transaminase
U/L	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Serum Aspartate Transaminase	17.3 ± 0.9	17.5 ± 0.8	19.5 ± 0.8	20.2 ± 1.0

SecondaryBlood Hematocrit

Data are biomarker concentrations at fasting

Time frame:: Day 28
Reported as:: Mean · Percent

Blood Hematocrit
Percent	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Blood Hematocrit	44.3 ± 0.7	45.1 ± 0.8	44.0 ± 0.6	43.5 ± 0.6

SecondaryPlasma Tumor Necrosis Factor-alpha

Data are biomarker fasting concentrations

Time frame:: Day 28
Reported as:: Mean · pg/mL

Plasma Tumor Necrosis Factor-alpha
pg/mL	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Plasma Tumor Necrosis Factor-alpha	1.2 ± 0.32	2.3 ± 0.53	4.8 ± 0.81	5.0 ± 0.62

SecondaryFecal Butyrate

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
Reported as:: Mean · umol/g

Fecal Butyrate
umol/g	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Fecal Butyrate	11.7 ± 1.8	10.8 ± 1.4	16.6 ± 2.4	13.9 ± 1.4

SecondaryFecal Acetate

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
Reported as:: Mean · umol/g

Fecal Acetate
umol/g	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Fecal Acetate	35.9 ± 5.2	33.1 ± 3.4	47.9 ± 4.1	41.9 ± 3.5

SecondaryFecal Valeric Acid

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
Reported as:: Mean · umol/g

Fecal Valeric Acid
umol/g	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Fecal Valeric Acid	0.95 ± 0.16	0.91 ± 0.13	2.04 ± 0.30	1.86 ± 0.25

SecondaryFecal Hexanoic Acid

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
Reported as:: Mean · umol/g

Fecal Hexanoic Acid
umol/g	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Fecal Hexanoic Acid	0.56 ± 0.16	0.49 ± 0.14	0.98 ± 0.59	0.55 ± 0.32

SecondaryFecal Isobutyric Acid

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
Reported as:: Mean · umol/g

Fecal Isobutyric Acid
umol/g	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Fecal Isobutyric Acid	1.86 ± 0.18	1.67 ± 0.22	1.87 ± 0.21	1.87 ± 0.15

SecondaryFecal 2-Methylbutyric

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
Reported as:: Mean · umol/g

Fecal 2-Methylbutyric
umol/g	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Fecal 2-Methylbutyric	1.29 ± 0.13	1.14 ± 0.16	1.20 ± 0.15	1.20 ± 0.11

SecondaryFecal Isovaleric Acid

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
Reported as:: Mean · umol/g

Fecal Isovaleric Acid
umol/g	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Fecal Isovaleric Acid	1.40 ± 0.14	1.22 ± 0.16	1.38 ± 0.16	1.40 ± 0.12

SecondaryPlasma Ascorbic Acid

Data are biomarker fasting concentrations

Time frame:: Day 28
Reported as:: Mean · umol/L

Plasma Ascorbic Acid
umol/L	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Plasma Ascorbic Acid	40.2 ± 4.7	41.6 ± 4.3	32.1 ± 4.5	28.6 ± 3.6

SecondaryPlasma Uric Acid

Data are biomarker fasting concentrations

Time frame:: Day 28
Reported as:: Mean · umol/L

Plasma Uric Acid
umol/L	Healthy - Placebo	Healthy - GTE	MetS - Placebo	MetS - GTE
Plasma Uric Acid	244.7 ± 13.8	256.0 ± 14.0	330.3 ± 13.9	319.8 ± 16.0

Adverse events

Collected over One month for each intervention. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Healthy Participants - GTE Confection Intervention	0/20 (0%)	0/20 (0%)	0/20 (0%)
Healthy Participants - Placebo Confection Intervention	0/20 (0%)	0/20 (0%)	0/20 (0%)
MetS Participants - GTE Confection Intervention	0/22 (0%)	0/22 (0%)	0/22 (0%)
MetS Participants - Placebo Confection Intervention	0/24 (0%)	0/24 (0%)	0/24 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Healthy-Placebo Then GTE	Healthy- GTE Then Placebo	MetS- Placebo Then GTE	MetS- GTE Then Placebo	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	9	10	10	11	40
>=65 years	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Healthy-Placebo Then GTE	Healthy- GTE Then Placebo	MetS- Placebo Then GTE	MetS- GTE Then Placebo	Total
Female	5	7	5	8	25
Male	4	3	5	3	15

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Healthy-Placebo Then GTE	Healthy- GTE Then Placebo	MetS- Placebo Then GTE	MetS- GTE Then Placebo	Total
Count of participants	—	—	—	—	0

Region of Enrollment
Region of Enrollment(participants)	Healthy-Placebo Then GTE	Healthy- GTE Then Placebo	MetS- Placebo Then GTE	MetS- GTE Then Placebo	Total
United States	9	10	10	11	40

BMI
BMI(kg/m^2)	Healthy-Placebo Then GTE	Healthy- GTE Then Placebo	MetS- Placebo Then GTE	MetS- GTE Then Placebo	Total
Mean	21.5 ± 1.3	23.1 ± 2.1	36.9 ± 5.5	33.7 ± 3.2	29.1 ± 7.4

Fasting blood glucose
Fasting blood glucose(mg/dL)	Healthy-Placebo Then GTE	Healthy- GTE Then Placebo	MetS- Placebo Then GTE	MetS- GTE Then Placebo	Total
Mean	87.1 ± 5.6	91.0 ± 5.9	105.0 ± 6.5	100.2 ± 10.3	96.1 ± 10.1

Fasting triglycerides
Fasting triglycerides(mg/dL)	Healthy-Placebo Then GTE	Healthy- GTE Then Placebo	MetS- Placebo Then GTE	MetS- GTE Then Placebo	Total
Mean	47.2 ± 16.8	73.5 ± 24.1	132.7 ± 66.1	199.5 ± 83.1	117.0 ± 81.0

Fasting HDL
Fasting HDL(mg/dL)	Healthy-Placebo Then GTE	Healthy- GTE Then Placebo	MetS- Placebo Then GTE	MetS- GTE Then Placebo	Total
Mean	64.3 ± 17.5	59.2 ± 12.7	42.3 ± 11.9	36.1 ± 5.6	49.7 ± 16.7

3 further baseline measures are reported on the registry.

Study locations

1 site

The Ohio State University
Columbus, Ohio 43210, United States

References and documents

Publications

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. PubMed 30856467 ↗
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. PubMed 29190550 ↗
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. PubMed 31799477 ↗
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. PubMed 38430822 ↗

Study documents

Protocol and statistical analysis plan ↗ · Jun 5, 2019

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2019 to primary completion in Mar 2021, 20 months.

Results were first posted in Dec 2025, 4 years 9 months after primary completion.

Of 71 non-industry interventional studies with no phase under Dysbiosis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 28. This study's 20 months is close to that.

Counting every sponsor, half of 83 studies reached it within 19 months; a quarter within 10 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered: May 30, 2019
First posted: Jun 4, 2019
StartActual: Jul 1, 2019
Primary completionActual: Mar 1, 2021
CompletionActual: Mar 1, 2021
Results first posted: Dec 2, 2025
Last update: Dec 19, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03973996
Lead sponsor: Ohio State University
Collaborators: United States Department of Agriculture (USDA)
Responsible party: Richard Bruno (Principal Investigator, Ohio State University) — Principal investigator
First posted: Jun 4, 2019
Start date: Jul 1, 2019
Primary completion: Mar 1, 2021
Completion: Mar 1, 2021
Results posted: Dec 2, 2025
Last update: Dec 19, 2025

Study contacts

Richard S Bruno, PhD, RD

principal investigator · Ohio State University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome

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