Dysbiosis, Endotoxemia, Inflammation, Metabolic Syndrome
Conditions
Keywords
Green tea, Gut barrier function, Gut dysbiosis, Inflammation, Metabolic endotoxemia, Metabolic syndrome, Microbiome
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.
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.
Interventions
DIETARY_SUPPLEMENTGreen Tea Extract
A gummy confection with catechin-rich green tea extract (1 g/d)
DIETARY_SUPPLEMENTPlacebo
A matched gummy confection formulated without green tea extract
Sponsors
United States Department of Agriculture (USDA)
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
* 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 birth control use for women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Endotoxin | Day 28 | Data are biomarker fasting concentrations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Lactulose/Mannitol Ratio | Day 28 | Lactulose/mannitol ratio in urine collected 0-5 h post-ingestion of non-digestible sugar probes. |
| Urinary Sucralose/Erythritol Ratio | Day 28 | Sucralose/Erythritol ratio measured in urine collected 0-24 h post-ingestion of non-digestible sugar probes |
| Plasma Interleukin-6 | Day 28 | Data are biomarker concentrations at fasting |
| Fecal Calprotectin | Day 25-27 (pooled samples) of the 28-day intervention | Data are biomarker fecal concentrations, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention. |
| Fecal Myeloperoxidase | Day 25-27 (pooled samples) of the 28-day intervention | Data are biomarker fecal concentrations, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention. |
| Plasma Epigallocatechin Gallate | Day 28 | Data are plasma concentrations of epigallocatechin gallate |
| Plasma Epicatechin | Day 28 | Data are plasma concentrations of epicatechin. |
| Plasma Epicatechin Gallate | Day 28 | Data are plasma concentrations of epicatechin gallate. |
| Plasma 3,4-γ-valerolactone | Day 28 | Data are biomarker concentrations at fasting |
| Plasma 3,4,5-γ-Valerolactone | Day 28 | Data are biomarker concentrations at fasting |
| Plasma Soluble Cluster of Differentiation-14 | Day 28 | Data are biomarker concentrations at fasting |
| Plasma Glucose | Day 28 | Data are biomarker concentrations at fasting |
| Plasma Insulin | Day 28 | Data are biomarker concentrations at fasting |
| Plasma Triglyceride | Day 28 | Data are biomarker concentrations at fasting |
| Plasma Lipopolysaccharide-binding Protein | Day 28 | Data are biomarker fasting concentrations |
| Serum Alanine Transaminase | Day 28 | Data are biomarker concentrations at fasting |
| Serum Aspartate Transaminase | Day 28 | Data are biomarker concentrations at fasting |
| Blood Hematocrit | Day 28 | Data are biomarker concentrations at fasting |
| Plasma Tumor Necrosis Factor-alpha | Day 28 | Data are biomarker fasting concentrations |
| Fecal Butyrate | Days 25-27 (pooled samples) of the 28-day intervention | Data are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention. |
| Fecal Acetate | Days 25-27 (pooled samples) of the 28-day intervention | Data are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention. |
| Fecal Valeric Acid | Day 25-27 (pooled samples) from the 28-day intervention | Data are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention. |
| Fecal Hexanoic Acid | Day 25-27 (pooled samples) from the 28-day intervention | Data are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention. |
| Fecal Isobutyric Acid | Day 25-27 (pooled samples) from the 28-day intervention | Data are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention. |
| Fecal 2-Methylbutyric | Day 25-27 (pooled samples) of the 28-day intervention | Data are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention. |
| Fecal Isovaleric Acid | Day 25-27 (pooled samples) of the 28-day intervention | Data are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention. |
| Plasma Ascorbic Acid | Day 28 | Data are biomarker fasting concentrations |
| Plasma Uric Acid | Day 28 | Data are biomarker fasting concentrations |
| Plasma Total Cholesterol | Day 28 | Data are biomarker concentrations at fasting |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 10 |
| 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 | 10 |
| 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. | 11 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| First Intervention (4 Weeks) | Withdrawal by Subject | 1 | 1 | 1 | 3 |
Baseline characteristics
| Characteristic | Healthy-Placebo Then GTE | Healthy- GTE Then Placebo | MetS- Placebo Then GTE | MetS- GTE Then Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 10 Participants | 10 Participants | 11 Participants | 40 Participants |
| BMI | 21.5 kg/m^2 STANDARD_DEVIATION 1.3 | 23.1 kg/m^2 STANDARD_DEVIATION 2.1 | 36.9 kg/m^2 STANDARD_DEVIATION 5.5 | 33.7 kg/m^2 STANDARD_DEVIATION 3.2 | 29.1 kg/m^2 STANDARD_DEVIATION 7.4 |
| Diastolic Blood Pressure | 74.6 mmHg STANDARD_DEVIATION 3.5 | 74.7 mmHg STANDARD_DEVIATION 5.7 | 85.0 mmHg STANDARD_DEVIATION 8.1 | 83.8 mmHg STANDARD_DEVIATION 6.8 | 79.8 mmHg STANDARD_DEVIATION 7.8 |
| Fasting blood glucose | 87.1 mg/dL STANDARD_DEVIATION 5.6 | 91.0 mg/dL STANDARD_DEVIATION 5.9 | 105.0 mg/dL STANDARD_DEVIATION 6.5 | 100.2 mg/dL STANDARD_DEVIATION 10.3 | 96.1 mg/dL STANDARD_DEVIATION 10.1 |
| Fasting HDL | 64.3 mg/dL STANDARD_DEVIATION 17.5 | 59.2 mg/dL STANDARD_DEVIATION 12.7 | 42.3 mg/dL STANDARD_DEVIATION 11.9 | 36.1 mg/dL STANDARD_DEVIATION 5.6 | 49.7 mg/dL STANDARD_DEVIATION 16.7 |
| Fasting triglycerides | 47.2 mg/dL STANDARD_DEVIATION 16.8 | 73.5 mg/dL STANDARD_DEVIATION 24.1 | 132.7 mg/dL STANDARD_DEVIATION 66.1 | 199.5 mg/dL STANDARD_DEVIATION 83.1 | 117.0 mg/dL STANDARD_DEVIATION 81 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment United States | 9 participants | 10 participants | 10 participants | 11 participants | 40 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 5 Participants | 8 Participants | 25 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 5 Participants | 3 Participants | 15 Participants |
| Systolic Blood Pressure | 115.4 mmHg STANDARD_DEVIATION 5.8 | 113.5 mmHg STANDARD_DEVIATION 7.6 | 125.5 mmHg STANDARD_DEVIATION 7.6 | 121.9 mmHg STANDARD_DEVIATION 10.4 | 119.3 mmHg STANDARD_DEVIATION 9.2 |
| Waist circumference | 77.4 cm STANDARD_DEVIATION 4.3 | 79.1 cm STANDARD_DEVIATION 6.9 | 114.7 cm STANDARD_DEVIATION 10.9 | 109.6 cm STANDARD_DEVIATION 12.4 | 96.0 cm STANDARD_DEVIATION 19.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 22 | 0 / 24 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 22 | 0 / 24 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 22 | 0 / 24 |
Outcome results
Primary
Serum Endotoxin
Data are biomarker fasting concentrations.
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Serum Endotoxin | 31.6 EU/mL | Standard Error 2.5 |
| Healthy - GTE | Serum Endotoxin | 26.7 EU/mL | Standard Error 2.6 |
| MetS - Placebo | Serum Endotoxin | 44.5 EU/mL | Standard Error 2.4 |
| MetS - GTE | Serum Endotoxin | 39.1 EU/mL | Standard Error 2.5 |
Secondary
Blood Hematocrit
Data are biomarker concentrations at fasting
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Blood Hematocrit | 44.3 Percent | Standard Error 0.7 |
| Healthy - GTE | Blood Hematocrit | 45.1 Percent | Standard Error 0.8 |
| MetS - Placebo | Blood Hematocrit | 44.0 Percent | Standard Error 0.6 |
| MetS - GTE | Blood Hematocrit | 43.5 Percent | Standard Error 0.6 |
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.
Time frame: Day 25-27 (pooled samples) of the 28-day intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Fecal 2-Methylbutyric | 1.29 umol/g | Standard Error 0.13 |
| Healthy - GTE | Fecal 2-Methylbutyric | 1.14 umol/g | Standard Error 0.16 |
| MetS - Placebo | Fecal 2-Methylbutyric | 1.20 umol/g | Standard Error 0.15 |
| MetS - GTE | Fecal 2-Methylbutyric | 1.20 umol/g | Standard Error 0.11 |
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.
Time frame: Days 25-27 (pooled samples) of the 28-day intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Fecal Acetate | 35.9 umol/g | Standard Error 5.2 |
| Healthy - GTE | Fecal Acetate | 33.1 umol/g | Standard Error 3.4 |
| MetS - Placebo | Fecal Acetate | 47.9 umol/g | Standard Error 4.1 |
| MetS - GTE | Fecal Acetate | 41.9 umol/g | Standard Error 3.5 |
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.
Time frame: Days 25-27 (pooled samples) of the 28-day intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Fecal Butyrate | 11.7 umol/g | Standard Error 1.8 |
| Healthy - GTE | Fecal Butyrate | 10.8 umol/g | Standard Error 1.4 |
| MetS - Placebo | Fecal Butyrate | 16.6 umol/g | Standard Error 2.4 |
| MetS - GTE | Fecal Butyrate | 13.9 umol/g | Standard Error 1.4 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Fecal Calprotectin | 35.9 ug/g | Standard Error 5.5 |
| Healthy - GTE | Fecal Calprotectin | 24.4 ug/g | Standard Error 2.7 |
| MetS - Placebo | Fecal Calprotectin | 42.5 ug/g | Standard Error 9.3 |
| MetS - GTE | Fecal Calprotectin | 36.7 ug/g | Standard Error 5.2 |
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.
Time frame: Day 25-27 (pooled samples) from the 28-day intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Fecal Hexanoic Acid | 0.56 umol/g | Standard Error 0.16 |
| Healthy - GTE | Fecal Hexanoic Acid | 0.49 umol/g | Standard Error 0.14 |
| MetS - Placebo | Fecal Hexanoic Acid | 0.98 umol/g | Standard Error 0.59 |
| MetS - GTE | Fecal Hexanoic Acid | 0.55 umol/g | Standard Error 0.32 |
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.
Time frame: Day 25-27 (pooled samples) from the 28-day intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Fecal Isobutyric Acid | 1.86 umol/g | Standard Error 0.18 |
| Healthy - GTE | Fecal Isobutyric Acid | 1.67 umol/g | Standard Error 0.22 |
| MetS - Placebo | Fecal Isobutyric Acid | 1.87 umol/g | Standard Error 0.21 |
| MetS - GTE | Fecal Isobutyric Acid | 1.87 umol/g | Standard Error 0.15 |
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.
Time frame: Day 25-27 (pooled samples) of the 28-day intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Fecal Isovaleric Acid | 1.40 umol/g | Standard Error 0.14 |
| Healthy - GTE | Fecal Isovaleric Acid | 1.22 umol/g | Standard Error 0.16 |
| MetS - Placebo | Fecal Isovaleric Acid | 1.38 umol/g | Standard Error 0.16 |
| MetS - GTE | Fecal Isovaleric Acid | 1.40 umol/g | Standard Error 0.12 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Fecal Myeloperoxidase | 97.4 ng/g | Standard Error 9.9 |
| Healthy - GTE | Fecal Myeloperoxidase | 83.4 ng/g | Standard Error 7.5 |
| MetS - Placebo | Fecal Myeloperoxidase | 148.1 ng/g | Standard Error 40.9 |
| MetS - GTE | Fecal Myeloperoxidase | 97.9 ng/g | Standard Error 10.5 |
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.
Time frame: Day 25-27 (pooled samples) from the 28-day intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Fecal Valeric Acid | 0.95 umol/g | Standard Error 0.16 |
| Healthy - GTE | Fecal Valeric Acid | 0.91 umol/g | Standard Error 0.13 |
| MetS - Placebo | Fecal Valeric Acid | 2.04 umol/g | Standard Error 0.3 |
| MetS - GTE | Fecal Valeric Acid | 1.86 umol/g | Standard Error 0.25 |
Secondary
Plasma 3,4,5-γ-Valerolactone
Data are biomarker concentrations at fasting
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Plasma 3,4,5-γ-Valerolactone | 0.001 umol/L | Standard Error 0.001 |
| Healthy - GTE | Plasma 3,4,5-γ-Valerolactone | 0.034 umol/L | Standard Error 0.017 |
| MetS - Placebo | Plasma 3,4,5-γ-Valerolactone | 0.0017 umol/L | Standard Error 0.001 |
| MetS - GTE | Plasma 3,4,5-γ-Valerolactone | 0.0060 umol/L | Standard Error 0.0047 |
Secondary
Plasma 3,4-γ-valerolactone
Data are biomarker concentrations at fasting
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Plasma 3,4-γ-valerolactone | 0.008 umol/L | Standard Error 0.005 |
| Healthy - GTE | Plasma 3,4-γ-valerolactone | 0.17 umol/L | Standard Error 0.05 |
| MetS - Placebo | Plasma 3,4-γ-valerolactone | 0.007 umol/L | Standard Error 0.003 |
| MetS - GTE | Plasma 3,4-γ-valerolactone | 0.090 umol/L | Standard Error 0.031 |
Secondary
Plasma Ascorbic Acid
Data are biomarker fasting concentrations
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Plasma Ascorbic Acid | 40.2 umol/L | Standard Error 4.7 |
| Healthy - GTE | Plasma Ascorbic Acid | 41.6 umol/L | Standard Error 4.3 |
| MetS - Placebo | Plasma Ascorbic Acid | 32.1 umol/L | Standard Error 4.5 |
| MetS - GTE | Plasma Ascorbic Acid | 28.6 umol/L | Standard Error 3.6 |
Secondary
Plasma Epicatechin
Data are plasma concentrations of epicatechin.
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Plasma Epicatechin | 0.0 umol/L | Standard Error 0 |
| Healthy - GTE | Plasma Epicatechin | 0.022 umol/L | Standard Error 0.0048 |
| MetS - Placebo | Plasma Epicatechin | 0.00016 umol/L | Standard Error 0.00016 |
| MetS - GTE | Plasma Epicatechin | 0.015 umol/L | Standard Error 0.003 |
Secondary
Plasma Epicatechin Gallate
Data are plasma concentrations of epicatechin gallate.
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Plasma Epicatechin Gallate | 0.002 umol/L | Standard Error 0.001 |
| Healthy - GTE | Plasma Epicatechin Gallate | 0.30 umol/L | Standard Error 0.037 |
| MetS - Placebo | Plasma Epicatechin Gallate | 0.002 umol/L | Standard Error 0.001 |
| MetS - GTE | Plasma Epicatechin Gallate | 0.20 umol/L | Standard Error 0.027 |
Secondary
Plasma Epigallocatechin Gallate
Data are plasma concentrations of epigallocatechin gallate
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Plasma Epigallocatechin Gallate | 0.001 umol/L | Standard Error 0.001 |
| Healthy - GTE | Plasma Epigallocatechin Gallate | 0.343 umol/L | Standard Error 0.057 |
| MetS - Placebo | Plasma Epigallocatechin Gallate | 0.00 umol/L | Standard Error 0 |
| MetS - GTE | Plasma Epigallocatechin Gallate | 0.21 umol/L | Standard Error 0.04 |
Secondary
Plasma Glucose
Data are biomarker concentrations at fasting
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Plasma Glucose | 86.3 mg/dL | Standard Error 1.6 |
| Healthy - GTE | Plasma Glucose | 83.9 mg/dL | Standard Error 1.5 |
| MetS - Placebo | Plasma Glucose | 98.9 mg/dL | Standard Error 3 |
| MetS - GTE | Plasma Glucose | 98.6 mg/dL | Standard Error 2.6 |
Secondary
Plasma Insulin
Data are biomarker concentrations at fasting
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Plasma Insulin | 6.4 μIU/mL | Standard Error 0.7 |
| Healthy - GTE | Plasma Insulin | 6.0 μIU/mL | Standard Error 0.6 |
| MetS - Placebo | Plasma Insulin | 19.6 μIU/mL | Standard Error 2.3 |
| MetS - GTE | Plasma Insulin | 22.4 μIU/mL | Standard Error 3.8 |
Secondary
Plasma Interleukin-6
Data are biomarker concentrations at fasting
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Plasma Interleukin-6 | 1.9 pg/mL | Standard Error 0.085 |
| Healthy - GTE | Plasma Interleukin-6 | 1.9 pg/mL | Standard Error 0.07 |
| MetS - Placebo | Plasma Interleukin-6 | 3.1 pg/mL | Standard Error 0.24 |
| MetS - GTE | Plasma Interleukin-6 | 3.3 pg/mL | Standard Error 0.29 |
Secondary
Plasma Lipopolysaccharide-binding Protein
Data are biomarker fasting concentrations
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Plasma Lipopolysaccharide-binding Protein | 4035 ng/mL | Standard Error 339 |
| Healthy - GTE | Plasma Lipopolysaccharide-binding Protein | 4435 ng/mL | Standard Error 380 |
| MetS - Placebo | Plasma Lipopolysaccharide-binding Protein | 7890 ng/mL | Standard Error 1143 |
| MetS - GTE | Plasma Lipopolysaccharide-binding Protein | 8572 ng/mL | Standard Error 1394 |
Secondary
Plasma Soluble Cluster of Differentiation-14
Data are biomarker concentrations at fasting
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Plasma Soluble Cluster of Differentiation-14 | 1465 ng/mL | Standard Error 57 |
| Healthy - GTE | Plasma Soluble Cluster of Differentiation-14 | 1459 ng/mL | Standard Error 71 |
| MetS - Placebo | Plasma Soluble Cluster of Differentiation-14 | 1424 ng/mL | Standard Error 67 |
| MetS - GTE | Plasma Soluble Cluster of Differentiation-14 | 1367 ng/mL | Standard Error 83 |
Secondary
Plasma Total Cholesterol
Data are biomarker concentrations at fasting
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Plasma Total Cholesterol | 195.5 mg/dL | Standard Error 9.4 |
| Healthy - GTE | Plasma Total Cholesterol | 186.9 mg/dL | Standard Error 6.7 |
| MetS - Placebo | Plasma Total Cholesterol | 220.1 mg/dL | Standard Error 9 |
| MetS - GTE | Plasma Total Cholesterol | 215.6 mg/dL | Standard Error 10.2 |
Secondary
Plasma Triglyceride
Data are biomarker concentrations at fasting
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Plasma Triglyceride | 51.2 mg/dL | Standard Error 4.1 |
| Healthy - GTE | Plasma Triglyceride | 54.7 mg/dL | Standard Error 4.9 |
| MetS - Placebo | Plasma Triglyceride | 140.5 mg/dL | Standard Error 14 |
| MetS - GTE | Plasma Triglyceride | 149.9 mg/dL | Standard Error 17 |
Secondary
Plasma Tumor Necrosis Factor-alpha
Data are biomarker fasting concentrations
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Plasma Tumor Necrosis Factor-alpha | 1.2 pg/mL | Standard Error 0.32 |
| Healthy - GTE | Plasma Tumor Necrosis Factor-alpha | 2.3 pg/mL | Standard Error 0.53 |
| MetS - Placebo | Plasma Tumor Necrosis Factor-alpha | 4.8 pg/mL | Standard Error 0.81 |
| MetS - GTE | Plasma Tumor Necrosis Factor-alpha | 5.0 pg/mL | Standard Error 0.62 |
Secondary
Plasma Uric Acid
Data are biomarker fasting concentrations
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Plasma Uric Acid | 244.7 umol/L | Standard Error 13.8 |
| Healthy - GTE | Plasma Uric Acid | 256.0 umol/L | Standard Error 14 |
| MetS - Placebo | Plasma Uric Acid | 330.3 umol/L | Standard Error 13.9 |
| MetS - GTE | Plasma Uric Acid | 319.8 umol/L | Standard Error 16 |
Secondary
Serum Alanine Transaminase
Data are biomarker concentrations at fasting
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Serum Alanine Transaminase | 15.0 (U/L) | Standard Error 0.9 |
| Healthy - GTE | Serum Alanine Transaminase | 15.0 (U/L) | Standard Error 1 |
| MetS - Placebo | Serum Alanine Transaminase | 24.2 (U/L) | Standard Error 2.1 |
| MetS - GTE | Serum Alanine Transaminase | 23.6 (U/L) | Standard Error 2.3 |
Secondary
Serum Aspartate Transaminase
Data are biomarker concentrations at fasting
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Serum Aspartate Transaminase | 17.3 U/L | Standard Error 0.9 |
| Healthy - GTE | Serum Aspartate Transaminase | 17.5 U/L | Standard Error 0.8 |
| MetS - Placebo | Serum Aspartate Transaminase | 19.5 U/L | Standard Error 0.8 |
| MetS - GTE | Serum Aspartate Transaminase | 20.2 U/L | Standard Error 1 |
Secondary
Urinary Lactulose/Mannitol Ratio
Lactulose/mannitol ratio in urine collected 0-5 h post-ingestion of non-digestible sugar probes.
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Urinary Lactulose/Mannitol Ratio | 0.075 ratio | Standard Error 0.009 |
| Healthy - GTE | Urinary Lactulose/Mannitol Ratio | 0.084 ratio | Standard Error 0.012 |
| MetS - Placebo | Urinary Lactulose/Mannitol Ratio | 0.087 ratio | Standard Error 0.013 |
| MetS - GTE | Urinary Lactulose/Mannitol Ratio | 0.065 ratio | Standard Error 0.007 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy - Placebo | Urinary Sucralose/Erythritol Ratio | 0.014 ratio | Standard Error 0.0014 |
| Healthy - GTE | Urinary Sucralose/Erythritol Ratio | 0.014 ratio | Standard Error 0.0015 |
| MetS - Placebo | Urinary Sucralose/Erythritol Ratio | 0.015 ratio | Standard Error 0.001 |
| MetS - GTE | Urinary Sucralose/Erythritol Ratio | 0.015 ratio | Standard Error 0.001 |