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| Name | Class |
|---|---|
| United States Department of Agriculture (USDA) | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Green Tea | Experimental | Participants consuming gummy confections with catechin-rich green tea extract daily for 4 weeks |
|
| Placebo | Placebo Comparator | Participants consuming matched gummy confections formulated without green tea extract daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Green Tea Extract | Dietary Supplement | A gummy confection with catechin-rich green tea extract (1 g/d) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Endotoxin | Data are biomarker fasting concentrations. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Lipopolysaccharide-binding Protein | Data are biomarker fasting concentrations | Day 28 |
| Urinary Lactulose/Mannitol Ratio | Lactulose/mannitol ratio in urine collected 0-5 h post-ingestion of non-digestible sugar probes. |
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Inclusion criteria:
Individuals with ≥3 of the following established criteria for metabolic syndrome:
Healthy adults:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard S Bruno, PhD, RD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30856467 | Background | 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. | |
| 29190550 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy - Placebo Then GTE | Participants with normal metabolic health will consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks, followed by a 4-week washout period, and then consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks. |
| FG001 | MetS - GTE Then Placebo | Participants with metabolic syndrome will consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks, followed by a 4-week washout period, and then consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks. |
| FG002 | Healthy- GTE Then Placebo | Participants with normal metabolic health will consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks, followed by a 4-week washout period, and then consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks. |
| FG003 | MetS - Placebo Then GTE | Participants with metabolic syndrome will consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks, followed by a 4-week washout period, and then consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (4 Weeks) |
|
| ||||||||||||||||||
| Washout (4 Weeks) |
| |||||||||||||||||||
| Second Intervention (4 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy-Placebo Then GTE | Participants with normal metabolic health will consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks, followed by a 4-week washout period, and then consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Endotoxin | Data are biomarker fasting concentrations. | Posted | Mean | Standard Error | EU/mL | Day 28 |
|
One month for each intervention
Includes all participants who received at least one dose of intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Participants - GTE Confection Intervention | Participants received GTE confections 3-times daily for 1-month, instructed to take with meals |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Bruno | Ohio State University | 8603358494 | bruno.27@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2019 | Jul 13, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D064806 | Dysbiosis |
| D019446 | Endotoxemia |
| D024821 | Metabolic Syndrome |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016470 | Bacteremia |
| D018805 | Sepsis |
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| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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| Placebo | Dietary Supplement | A matched gummy confection formulated without green tea extract |
|
| Day 28 |
| Urinary Sucralose/Erythritol Ratio | Sucralose/Erythritol ratio measured in urine collected 0-24 h post-ingestion of non-digestible sugar probes | Day 28 |
| Plasma Interleukin-6 | Data are biomarker concentrations at fasting | 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. | 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. | Day 25-27 (pooled samples) of the 28-day intervention |
| Plasma Epigallocatechin Gallate | Data are plasma concentrations of epigallocatechin gallate | Day 28 |
| Plasma Epicatechin | Data are plasma concentrations of epicatechin. | Day 28 |
| Plasma Epicatechin Gallate | Data are plasma concentrations of epicatechin gallate. | Day 28 |
| Plasma 3,4-γ-valerolactone | Data are biomarker concentrations at fasting | Day 28 |
| Plasma 3,4,5-γ-Valerolactone | Data are biomarker concentrations at fasting | Day 28 |
| Plasma Soluble Cluster of Differentiation-14 | Data are biomarker concentrations at fasting | Day 28 |
| Plasma Glucose | Data are biomarker concentrations at fasting | Day 28 |
| Plasma Insulin | Data are biomarker concentrations at fasting | Day 28 |
| Plasma Triglyceride | Data are biomarker concentrations at fasting | Day 28 |
| Plasma Total Cholesterol | Data are biomarker concentrations at fasting | Day 28 |
| Serum Alanine Transaminase | Data are biomarker concentrations at fasting | Day 28 |
| Serum Aspartate Transaminase | Data are biomarker concentrations at fasting | Day 28 |
| Blood Hematocrit | Data are biomarker concentrations at fasting | Day 28 |
| Plasma Tumor Necrosis Factor-alpha | Data are biomarker fasting concentrations | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Day 25-27 (pooled samples) of the 28-day intervention |
| Plasma Ascorbic Acid | Data are biomarker fasting concentrations | Day 28 |
| Plasma Uric Acid | Data are biomarker fasting concentrations | Day 28 |
| 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. |
| 31799477 | Background | 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. |
| 38430822 | Result | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Healthy- GTE Then Placebo |
Participants with normal metabolic health will consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks, followed by a 4-week washout period, and then consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks. |
| BG002 | MetS- Placebo Then GTE | Participants with metabolic syndrome will consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks, followed by a 4-week washout period, and then consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 week |
| BG003 | MetS- GTE Then Placebo | Participants with metabolic syndrome will consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks, followed by a 4-week washout period, and then consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Fasting blood glucose | Mean | Standard Deviation | mg/dL |
|
| Fasting triglycerides | Mean | Standard Deviation | mg/dL |
|
| Fasting HDL | Mean | Standard Deviation | mg/dL |
|
| Waist circumference | Mean | Standard Deviation | cm |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| OG003 | MetS - GTE | Confection without green tea extract consumed daily for 4 weeks. |
|
|
| Secondary | Plasma Lipopolysaccharide-binding Protein | Data are biomarker fasting concentrations | Posted | Mean | Standard Error | ng/mL | Day 28 |
|
|
|
| Secondary | Urinary Lactulose/Mannitol Ratio | Lactulose/mannitol ratio in urine collected 0-5 h post-ingestion of non-digestible sugar probes. | Posted | Mean | Standard Error | ratio | Day 28 |
|
|
|
| Secondary | Urinary Sucralose/Erythritol Ratio | Sucralose/Erythritol ratio measured in urine collected 0-24 h post-ingestion of non-digestible sugar probes | Posted | Mean | Standard Error | ratio | Day 28 |
|
|
|
| Secondary | Plasma Interleukin-6 | Data are biomarker concentrations at fasting | Posted | Mean | Standard Error | pg/mL | Day 28 |
|
|
|
| Secondary | Fecal Calprotectin | Data are biomarker fecal concentrations, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention. | Posted | Mean | Standard Error | ug/g | Day 25-27 (pooled samples) of the 28-day intervention |
|
|
|
| Secondary | Fecal Myeloperoxidase | Data are biomarker fecal concentrations, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention. | Posted | Mean | Standard Error | ng/g | Day 25-27 (pooled samples) of the 28-day intervention |
|
|
|
| Secondary | Plasma Epigallocatechin Gallate | Data are plasma concentrations of epigallocatechin gallate | Posted | Mean | Standard Error | umol/L | Day 28 |
|
|
|
| Secondary | Plasma Epicatechin | Data are plasma concentrations of epicatechin. | Posted | Mean | Standard Error | umol/L | Day 28 |
|
|
|
| Secondary | Plasma Epicatechin Gallate | Data are plasma concentrations of epicatechin gallate. | Posted | Mean | Standard Error | umol/L | Day 28 |
|
|
|
| Secondary | Plasma 3,4-γ-valerolactone | Data are biomarker concentrations at fasting | Posted | Mean | Standard Error | umol/L | Day 28 |
|
|
|
| Secondary | Plasma 3,4,5-γ-Valerolactone | Data are biomarker concentrations at fasting | Posted | Mean | Standard Error | umol/L | Day 28 |
|
|
|
| Secondary | Plasma Soluble Cluster of Differentiation-14 | Data are biomarker concentrations at fasting | Posted | Mean | Standard Error | ng/mL | Day 28 |
|
|
|
| Secondary | Plasma Glucose | Data are biomarker concentrations at fasting | Posted | Mean | Standard Error | mg/dL | Day 28 |
|
|
|
| Secondary | Plasma Insulin | Data are biomarker concentrations at fasting | Posted | Mean | Standard Error | μIU/mL | Day 28 |
|
|
|
| Secondary | Plasma Triglyceride | Data are biomarker concentrations at fasting | Posted | Mean | Standard Error | mg/dL | Day 28 |
|
|
|
| Secondary | Plasma Total Cholesterol | Data are biomarker concentrations at fasting | Posted | Mean | Standard Error | mg/dL | Day 28 |
|
|
|
| Secondary | Serum Alanine Transaminase | Data are biomarker concentrations at fasting | Posted | Mean | Standard Error | (U/L) | Day 28 |
|
|
|
| Secondary | Serum Aspartate Transaminase | Data are biomarker concentrations at fasting | Posted | Mean | Standard Error | U/L | Day 28 |
|
|
|
| Secondary | Blood Hematocrit | Data are biomarker concentrations at fasting | Posted | Mean | Standard Error | Percent | Day 28 |
|
|
|
| Secondary | Plasma Tumor Necrosis Factor-alpha | Data are biomarker fasting concentrations | Posted | Mean | Standard Error | pg/mL | Day 28 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | umol/g | Days 25-27 (pooled samples) of the 28-day intervention |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | umol/g | Days 25-27 (pooled samples) of the 28-day intervention |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | umol/g | Day 25-27 (pooled samples) from the 28-day intervention |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | umol/g | Day 25-27 (pooled samples) from the 28-day intervention |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | umol/g | Day 25-27 (pooled samples) from the 28-day intervention |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | umol/g | Day 25-27 (pooled samples) of the 28-day intervention |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | umol/g | Day 25-27 (pooled samples) of the 28-day intervention |
|
|
|
| Secondary | Plasma Ascorbic Acid | Data are biomarker fasting concentrations | Posted | Mean | Standard Error | umol/L | Day 28 |
|
|
|
| Secondary | Plasma Uric Acid | Data are biomarker fasting concentrations | Posted | Mean | Standard Error | umol/L | Day 28 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Healthy Participants - Placebo Confection Intervention | Participants received Placebo confections 3-times daily for 1-month, instructed to take with meals | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | MetS Participants - GTE Confection Intervention | Participants received GTE confections 3-times daily for 1-month, instructed to take with meals | 0 | 22 | 0 | 22 | 0 | 22 |
| EG003 | MetS Participants - Placebo Confection Intervention | Participants received Placebo confections 3-times daily for 1-month, instructed to take with meals | 0 | 24 | 0 | 24 | 0 | 24 |
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| D007239 |
| Infections |
| D014115 | Toxemia |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|