DysbiosisNCT03973996
Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome
A study testing Green Tea Extract in people with Dysbiosis and Endotoxemia, run by Ohio State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysbiosis, Endotoxemia, Metabolic Syndrome
- What is being tested?
- Green Tea Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Dysbiosis, Endotoxemia, Metabolic Syndrome, Inflammation
- Being tested
- Green Tea Extract, Placebo
- Keywords
- Green tea, Gut barrier function, Gut dysbiosis, Inflammation, Metabolic endotoxemia, Metabolic syndrome, Microbiome
- Medical subject headings
- Dysbiosis, Endotoxemia, Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green Tea ExtractDietary supplement
Also called Camellia sinesis plant extract
A gummy confection with catechin-rich green tea extract (1 g/d)
PlaceboDietary supplement
A matched gummy confection formulated without green tea extract
| Study group | Role | What they receive |
|---|---|---|
| Green Tea | Experimental | Participants consuming gummy confections with catechin-rich green tea extract daily for 4 weeks Receives: Dietary Supplement: Green Tea Extract |
| Placebo | Placebo comparator | Participants consuming matched gummy confections formulated without green tea extract daily for 4 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Endotoxin
Data are biomarker fasting concentrations.
Measured: Day 28
Secondary outcomes (29)
Plasma Lipopolysaccharide-binding Protein
Data are biomarker fasting concentrations
Measured: Day 28
Urinary Lactulose/Mannitol Ratio
Lactulose/mannitol ratio in urine collected 0-5 h post-ingestion of non-digestible sugar probes.
Measured: Day 28
Urinary Sucralose/Erythritol Ratio
Sucralose/Erythritol ratio measured in urine collected 0-24 h post-ingestion of non-digestible sugar probes
Measured: Day 28
Plasma Interleukin-6
Data are biomarker concentrations at fasting
Measured: 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.
Measured: 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.
Measured: Day 25-27 (pooled samples) of the 28-day intervention
Plasma Epigallocatechin Gallate
Data are plasma concentrations of epigallocatechin gallate
Measured: Day 28
Plasma Epicatechin
Data are plasma concentrations of epicatechin.
Measured: Day 28
Plasma Epicatechin Gallate
Data are plasma concentrations of epicatechin gallate.
Measured: Day 28
Plasma 3,4-γ-valerolactone
Data are biomarker concentrations at fasting
Measured: Day 28
Plasma 3,4,5-γ-Valerolactone
Data are biomarker concentrations at fasting
Measured: Day 28
Plasma Soluble Cluster of Differentiation-14
Data are biomarker concentrations at fasting
Measured: Day 28
Plasma Glucose
Data are biomarker concentrations at fasting
Measured: Day 28
Plasma Insulin
Data are biomarker concentrations at fasting
Measured: Day 28
Plasma Triglyceride
Data are biomarker concentrations at fasting
Measured: Day 28
Plasma Total Cholesterol
Data are biomarker concentrations at fasting
Measured: Day 28
Serum Alanine Transaminase
Data are biomarker concentrations at fasting
Measured: Day 28
Serum Aspartate Transaminase
Data are biomarker concentrations at fasting
Measured: Day 28
Blood Hematocrit
Data are biomarker concentrations at fasting
Measured: Day 28
Plasma Tumor Necrosis Factor-alpha
Data are biomarker fasting concentrations
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 25-27 (pooled samples) of the 28-day intervention
Plasma Ascorbic Acid
Data are biomarker fasting concentrations
Measured: Day 28
Plasma Uric Acid
Data are biomarker fasting concentrations
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Jul 2019
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DysbiosisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Richard Bruno, Ohio State University
- Investigators
- Richard S Bruno, PhD, RD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973996
- Sponsor's protocol ID
- 2018H0592
- Status last verified
- Dec 2025
- First submitted
- 30 May 2019
- Last updated
- 19 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 30856467Li 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 29190550Hodges 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 31799477Zeng 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 at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03973996
- Acronym / sponsor ID
- 2018H0592
- Conditions
- Dysbiosis, Endotoxemia, Metabolic Syndrome, Inflammation
- Keywords
- Green tea, Gut barrier function, Gut dysbiosis, Inflammation, Metabolic endotoxemia, Metabolic syndrome, Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Posted 2 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green Tea | Experimental | Dietary Supplement: Green Tea ExtractParticipants consuming gummy confections with catechin-rich green tea extract daily for 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants consuming matched gummy confections formulated without green tea extract daily for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green Tea ExtractAlso: Camellia sinesis plant extractA gummy confection with catechin-rich green tea extract (1 g/d) | Dietary supplement | Green Tea |
| PlaceboA matched gummy confection formulated without green tea extract | Dietary supplement | Placebo |
Primary outcome
Serum Endotoxin
Time frame: Day 28
Data are biomarker fasting concentrations.
29 secondary outcomes
Plasma Lipopolysaccharide-binding Protein
Time frame: Day 28
Urinary Lactulose/Mannitol Ratio
Time frame: Day 28
Urinary Sucralose/Erythritol Ratio
Time frame: Day 28
Plasma Interleukin-6
Time frame: Day 28
Fecal Calprotectin
Time frame: Day 25-27 (pooled samples) of the 28-day intervention
Fecal Myeloperoxidase
Time frame: Day 25-27 (pooled samples) of the 28-day intervention
Plasma Epigallocatechin Gallate
Time frame: Day 28
Plasma Epicatechin
Time frame: Day 28
Plasma Epicatechin Gallate
Time frame: Day 28
Plasma 3,4-γ-valerolactone
Time frame: Day 28
Plasma 3,4,5-γ-Valerolactone
Time frame: Day 28
Plasma Soluble Cluster of Differentiation-14
Time frame: Day 28
Plasma Glucose
Time frame: Day 28
Plasma Insulin
Time frame: Day 28
Plasma Triglyceride
Time frame: Day 28
Plasma Total Cholesterol
Time frame: Day 28
Serum Alanine Transaminase
Time frame: Day 28
Serum Aspartate Transaminase
Time frame: Day 28
Blood Hematocrit
Time frame: Day 28
Plasma Tumor Necrosis Factor-alpha
Time frame: Day 28
Fecal Butyrate
Time frame: Days 25-27 (pooled samples) of the 28-day intervention
Fecal Acetate
Time frame: Days 25-27 (pooled samples) of the 28-day intervention
Fecal Valeric Acid
Time frame: Day 25-27 (pooled samples) from the 28-day intervention
Fecal Hexanoic Acid
Time frame: Day 25-27 (pooled samples) from the 28-day intervention
Fecal Isobutyric Acid
Time frame: Day 25-27 (pooled samples) from the 28-day intervention
Fecal 2-Methylbutyric
Time frame: Day 25-27 (pooled samples) of the 28-day intervention
Fecal Isovaleric Acid
Time frame: Day 25-27 (pooled samples) of the 28-day intervention
Plasma Ascorbic Acid
Time frame: Day 28
Plasma Uric Acid
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30856467Dey 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.
- Background: PubMed 29190550Li 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.
- Background: PubMed 31799477Hodges 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.
- Results publication: PubMed 38430822Zeng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard S Bruno, PhD, RD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green Tea Extract in people with Dysbiosis and Endotoxemia, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Endotoxin (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03973996, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.