Endotoxemia, Inflammation, Obesity
Conditions
Brief summary
This study is focused on assessing gastrointestinal-level improvements by which green tea limits metabolic endotoxemia. It is completed in two phases. Phase I consists of a pharmacokinetic study to examine the bioavailability of green tea catechins among lean and obese persons who consumed a single dose of a green tea extract (GTE)-containing confection. These persons will then complete phase 2, which consists of a parallel design randomized controlled in which lean and obese persons will consume placebo or GTE confections. It is expected that catechin-rich green tea will improve gut barrier function to prevent endotoxin translocation and associated low-grade inflammation. Outcomes will therefore support dietary recommendations for green tea to alleviate obesity-related inflammatory responses. Specifically, the study is expected to demonstrate that a green tea confection snack food can attenuate metabolic endotoxemia in association with restoring gastrointestinal health.
Detailed description
Obesity is a major public health concern in the United States, with over two-thirds of the adult population classified as overweight or obese. Obesity is characterized by low-grade chronic inflammation that, in part, is mediated by metabolic endotoxemia. Metabolic endotoxemia describes increased circulating levels of gut-derived endotoxin (a bacterial product derived from Gram-negative bacteria in the intestines) that results from gut barrier dysfunction, a phenomenon that is common in obesity. Studies in rodents models have shown that dietary supplementation with green tea extract (GTE) reduces metabolic endotoxemia in association with improved gut health. This clinical trial will therefore investigate the extent to which a green tea confection snack food can alleviate metabolic endotoxemia and restore gut health in obese humans. It is hypothesized that 4-week daily ingestion of a green tea extract (GTE)-rich confection will limit metabolic endotoxemia by decreasing gut barrier permeability. This study will address the following objectives: 1) define alterations in catechin pharmacokinetics in obese compared with healthy adults, 2) demonstrate improvements in gut barrier function by GTE, and 3) demonstrate GTE-mediated amelioration of microbial dysbiosis. To test the hypothesis, all participants will initially complete a 12-h pharmacokinetics study to define the influence of obesity on catechin bioavailability and metabolism. They will then be randomized to complete a double-blind, randomized, placebo-controlled trial where they will receive a GTE-rich or placebo confection for 4 weeks. Prior to and upon completing the intervention, participants will undergo a gut permeability test, fecal samples will be collected for microbiota composition analysis, and blood samples will be collected to assess endotoxin and inflammatory biomarkers. Upon successfully completing this study, it is anticipated that chronic consumption of a green tea confection will be demonstrated to be an effective dietary strategy to reduce metabolic endotoxemia and improve gut health.
Interventions
OTHERGreen Tea Extract
Confections containing green tea extract that will be ingested daily for 4 weeks
OTHERPlacebo
Confections containing no green tea extract that will be ingested daily for 4 weeks
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Overweight/obese (BMI = 28-40 kg/m2) * Fasting glucose \< 126 mg/dL * Normotensive (blood pressure \< 140/90 mmHg) * Non-dietary supplement user * Non-smoker
Exclusion criteria
* Regular tea drinkers (\> 2 cups/week) * Vegetarians * Use of medications to manage diabetes, hypertension, or hyperlipidemia * Use of any medications known to be contraindicated for use with green tea ingestion * User of dietary supplements, prebiotics, or probiotics * Recent use of antibiotics or anti-inflammatory agents * Women who are pregnant or lactating or have initiated or changed birth control in the past 3-months * Individuals with gastrointestinal disorders or surgeries * Individuals with hemochromatosis * Alcohol intake \> 3 drinks per day * Any history of cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endotoxin | Week 0 - Fasting | Serum endotoxin concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut Permeability - Sucralose to Erythritol Ratio | Week 0 - 6-24 hours | Urinary Sucralose/Erythritol Ratio (mg/mg) |
| Urinary Sucralose/Erythritol Ratio (mg/mg) | Week 4 - 6-24 hours | Ratio of excretion of urinary sugars (Sucralose to Erythritol) |
| Firmicutes to Bacteroidetes Ratio - Microbiota | Week 0 | Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance) |
| Bioavailability - Epigallocatechin Gallate | Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection | Area under the curve (AUC) of plasma epigallocatechin calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epigallocatechin gallate is measured in umol/L over time (hours) resulting in the AUC. |
| Bioavailability - Epigallocatechin | Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection | Area under the curve (AUC) of plasma epigallocatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epigallocatechin is measured in umol/L over time (hours) resulting in the AUC. |
| Bioavailability - Epicatechin Gallate | Prior to the intervention enrollment...0-12 hours post-ingestion of a green tea confection | Area under the curve (AUC) of plasma epicatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epicatechins is measured in umol/L over time (hours) resulting in the AUC. |
| Bioavailability - Epicatechin | Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection | Area under the curve (AUC) of plasma epicatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epicatechin is measured in umol/L over time (hours) resulting in the AUC. |
| Cmax of Epigallocatechin Gallate | Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection | Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection |
| Gut Permeability - Lactulose to Mannitol Ratio | Week 0 - 0-5 hours | Urinary Lactulose/Mannitol Ratio (mg/mg) |
| Cmax of Epicatechin Gallate | Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection | Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection |
| Cmax of Epicatechin | Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection | Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection |
| Tmax of Epigallocatechin Gallate | Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection | Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection |
| Tmax of Epigallocatechin | Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection | Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection |
| Tmax of Epicatechin Gallate | Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection | Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection |
| Tmax of Epicatechin | Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection | Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection |
| Calprotectin | Week 0 | Fecal calprotectin concentration |
| Cmax of Epigallocatechin | Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection | Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection |
Countries
United States
Participant flow
Pre-assignment details
In Phase 1, participants were stratified by phenotype (lean vs. obese) and received a single dose of a green tea extract (GTE)-enriched confection. This phase was conducted to evaluate catechin bioavailability. All participants consumed the same GTE confection. After a washout period, participants were randomized in Phase 2 to receive either a GTE or placebo confection daily for 4 weeks in a double-blind trial.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Confection Confection without green tea extract consumed daily for 4 weeks
Placebo: Confections containing no green tea extract that will be ingested daily for 4 weeks | 20 |
| Green Tea Extract-Confection Confection with green tea extract consumed daily for 4 weeks
Green Tea Extract: Confections containing green tea extract that will be ingested daily for 4 weeks | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Green Tea Extract-Confection | Total | Placebo Confection |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 40 Participants | 20 Participants |
| Age, Continuous | 28.35 years STANDARD_DEVIATION 9.04 | 28.175 years STANDARD_DEVIATION 7.77 | 28. years STANDARD_DEVIATION 6.48 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 8 Participants | 20 Participants | 12 Participants |
| Sex: Female, Male Male | 12 Participants | 20 Participants | 8 Participants |
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 / 10 | 0 / 9 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 9 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Endotoxin
Serum endotoxin concentration
Time frame: Week 0 - Fasting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Endotoxin | 14.44 EU/mL | Standard Deviation 4.46 |
| Obese - GTE | Endotoxin | 12.97 EU/mL | Standard Deviation 6.44 |
| Lean - Placebo | Endotoxin | 12.25 EU/mL | Standard Deviation 6.05 |
| Obese - Placebo | Endotoxin | 17.65 EU/mL | Standard Deviation 12.58 |
Primary
Endotoxin
Serum endotoxin concentration
Time frame: Week 2 - Fasting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Endotoxin | 13.59 EU/mL | Standard Deviation 7.38 |
| Obese - GTE | Endotoxin | 12.38 EU/mL | Standard Deviation 7.53 |
| Lean - Placebo | Endotoxin | 13.00 EU/mL | Standard Deviation 5.44 |
| Obese - Placebo | Endotoxin | 15.62 EU/mL | Standard Deviation 5.32 |
Primary
Endotoxin
Serum endotoxin concentration
Time frame: Week 4 - Fasting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Endotoxin | 12.33 EU/mL | Standard Deviation 4.55 |
| Obese - GTE | Endotoxin | 16.46 EU/mL | Standard Deviation 4.91 |
| Lean - Placebo | Endotoxin | 11.33 EU/mL | Standard Deviation 5.56 |
| Obese - Placebo | Endotoxin | 15.45 EU/mL | Standard Deviation 6.94 |
Secondary
Bioavailability - Epicatechin
Area under the curve (AUC) of plasma epicatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epicatechin is measured in umol/L over time (hours) resulting in the AUC.
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection
Population: A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Bioavailability - Epicatechin | 0.78 umol/L x h | Standard Error 0.1 |
| Obese - GTE | Bioavailability - Epicatechin | 0.57 umol/L x h | Standard Error 0.04 |
Secondary
Bioavailability - Epicatechin Gallate
Area under the curve (AUC) of plasma epicatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epicatechins is measured in umol/L over time (hours) resulting in the AUC.
Time frame: Prior to the intervention enrollment...0-12 hours post-ingestion of a green tea confection
Population: A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Bioavailability - Epicatechin Gallate | 1.06 umol/L x h | Standard Error 0.1 |
| Obese - GTE | Bioavailability - Epicatechin Gallate | 0.78 umol/L x h | Standard Error 0.1 |
Secondary
Bioavailability - Epigallocatechin
Area under the curve (AUC) of plasma epigallocatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epigallocatechin is measured in umol/L over time (hours) resulting in the AUC.
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection
Population: A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Bioavailability - Epigallocatechin | 1.18 umol/L x h | Standard Error 0.1 |
| Obese - GTE | Bioavailability - Epigallocatechin | 0.88 umol/L x h | Standard Error 0.1 |
Secondary
Bioavailability - Epigallocatechin Gallate
Area under the curve (AUC) of plasma epigallocatechin calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epigallocatechin gallate is measured in umol/L over time (hours) resulting in the AUC.
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection
Population: A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Bioavailability - Epigallocatechin Gallate | 3.46 umol/L x h | Standard Error 0.3 |
| Obese - GTE | Bioavailability - Epigallocatechin Gallate | 2.62 umol/L x h | Standard Error 0.3 |
Secondary
Calprotectin
Fecal calprotectin concentration
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Calprotectin | 249.62 ug/g | Standard Deviation 590.21 |
| Obese - GTE | Calprotectin | 25.74 ug/g | Standard Deviation 13.94 |
| Lean - Placebo | Calprotectin | 36.20 ug/g | Standard Deviation 24.15 |
| Obese - Placebo | Calprotectin | 73.04 ug/g | Standard Deviation 103.9 |
Secondary
Calprotectin
Fecal calprotectin concentration
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Calprotectin | 64.99 ug/g | Standard Deviation 79.07 |
| Obese - GTE | Calprotectin | 27.54 ug/g | Standard Deviation 20.58 |
| Lean - Placebo | Calprotectin | 32.01 ug/g | Standard Deviation 25.52 |
| Obese - Placebo | Calprotectin | 62.62 ug/g | Standard Deviation 90.84 |
Secondary
Cmax of Epicatechin
Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Population: A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Cmax of Epicatechin | 0.16 umol/L | Standard Error 0.1 |
| Obese - GTE | Cmax of Epicatechin | 0.13 umol/L | Standard Error 0.1 |
Secondary
Cmax of Epicatechin Gallate
Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Population: A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Cmax of Epicatechin Gallate | 0.14 umol/L | Standard Error 0.01 |
| Obese - GTE | Cmax of Epicatechin Gallate | 0.09 umol/L | Standard Error 0.01 |
Secondary
Cmax of Epigallocatechin
Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Population: A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Cmax of Epigallocatechin | 0.22 umol/L | Standard Error 0.01 |
| Obese - GTE | Cmax of Epigallocatechin | 0.18 umol/L | Standard Error 0.01 |
Secondary
Cmax of Epigallocatechin Gallate
Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Population: A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Cmax of Epigallocatechin Gallate | 0.5 umol/L | Standard Error 0.04 |
| Obese - GTE | Cmax of Epigallocatechin Gallate | 0.38 umol/L | Standard Error 0.03 |
Secondary
Firmicutes to Bacteroidetes Ratio - Microbiota
Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Firmicutes to Bacteroidetes Ratio - Microbiota | 4.34 % of abundance | Standard Deviation 3.17 |
| Obese - GTE | Firmicutes to Bacteroidetes Ratio - Microbiota | 3.52 % of abundance | Standard Deviation 2.32 |
| Lean - Placebo | Firmicutes to Bacteroidetes Ratio - Microbiota | 21.51 % of abundance | Standard Deviation 31.65 |
| Obese - Placebo | Firmicutes to Bacteroidetes Ratio - Microbiota | 9.36 % of abundance | Standard Deviation 7.48 |
Secondary
Firmicutes to Bacteroidetes Ratio - Microbiota
Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Firmicutes to Bacteroidetes Ratio - Microbiota | 4.90 ratio | Standard Deviation 3.74 |
| Obese - GTE | Firmicutes to Bacteroidetes Ratio - Microbiota | 8.95 ratio | Standard Deviation 15.13 |
| Lean - Placebo | Firmicutes to Bacteroidetes Ratio - Microbiota | 4.69 ratio | Standard Deviation 4.17 |
| Obese - Placebo | Firmicutes to Bacteroidetes Ratio - Microbiota | 9.32 ratio | Standard Deviation 3.95 |
Secondary
Gut Permeability - Lactulose to Mannitol Ratio
Urinary Lactulose/Mannitol Ratio (mg/mg)
Time frame: Week 0 - 6-24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Gut Permeability - Lactulose to Mannitol Ratio | 0.16 Urinary Lactulose/Mannitol Ratio (mg/mg) | Standard Deviation 0.1 |
| Obese - GTE | Gut Permeability - Lactulose to Mannitol Ratio | 0.11 Urinary Lactulose/Mannitol Ratio (mg/mg) | Standard Deviation 0.1 |
| Lean - Placebo | Gut Permeability - Lactulose to Mannitol Ratio | 0.19 Urinary Lactulose/Mannitol Ratio (mg/mg) | Standard Deviation 0.12 |
| Obese - Placebo | Gut Permeability - Lactulose to Mannitol Ratio | 0.19 Urinary Lactulose/Mannitol Ratio (mg/mg) | Standard Deviation 0.14 |
Secondary
Gut Permeability - Lactulose to Mannitol Ratio
Urinary Lactulose/Mannitol Ratio (mg/mg)
Time frame: Week 4 - 6-24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Gut Permeability - Lactulose to Mannitol Ratio | 0.14 Urinary Lactulose/Mannitol Ratio (mg/mg) | Standard Deviation 0.11 |
| Obese - GTE | Gut Permeability - Lactulose to Mannitol Ratio | 0.18 Urinary Lactulose/Mannitol Ratio (mg/mg) | Standard Deviation 0.18 |
| Lean - Placebo | Gut Permeability - Lactulose to Mannitol Ratio | 0.19 Urinary Lactulose/Mannitol Ratio (mg/mg) | Standard Deviation 0.12 |
| Obese - Placebo | Gut Permeability - Lactulose to Mannitol Ratio | 0.21 Urinary Lactulose/Mannitol Ratio (mg/mg) | Standard Deviation 0.12 |
Secondary
Gut Permeability - Lactulose to Mannitol Ratio
Urinary Lactulose/Mannitol Ratio (mg/mg)
Time frame: Week 0 - 0-5 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Gut Permeability - Lactulose to Mannitol Ratio | 0.12 Ratio | Standard Deviation 0.06 |
| Obese - GTE | Gut Permeability - Lactulose to Mannitol Ratio | 0.09 Ratio | Standard Deviation 0.03 |
| Lean - Placebo | Gut Permeability - Lactulose to Mannitol Ratio | 0.10 Ratio | Standard Deviation 0.05 |
| Obese - Placebo | Gut Permeability - Lactulose to Mannitol Ratio | 0.10 Ratio | Standard Deviation 0.03 |
Secondary
Gut Permeability - Lactulose to Mannitol Ratio
Urinary Lactulose/Mannitol Ratio (mg/mg)
Time frame: Week 4 - 0-5 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Gut Permeability - Lactulose to Mannitol Ratio | 0.12 Urinary Lactulose/Mannitol Ratio (mg/mg) | Standard Deviation 0.13 |
| Obese - GTE | Gut Permeability - Lactulose to Mannitol Ratio | 0.14 Urinary Lactulose/Mannitol Ratio (mg/mg) | Standard Deviation 0.1 |
| Lean - Placebo | Gut Permeability - Lactulose to Mannitol Ratio | 0.10 Urinary Lactulose/Mannitol Ratio (mg/mg) | Standard Deviation 0.06 |
| Obese - Placebo | Gut Permeability - Lactulose to Mannitol Ratio | 0.12 Urinary Lactulose/Mannitol Ratio (mg/mg) | Standard Deviation 0.08 |
Secondary
Gut Permeability - Sucralose to Erythritol Ratio
Urinary Sucralose/Erythritol Ratio (mg/mg)
Time frame: Week 0 - 0-24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Gut Permeability - Sucralose to Erythritol Ratio | 0.02 Urinary Sucralose/Erythritol (mg/m | Standard Deviation 0.01 |
| Obese - GTE | Gut Permeability - Sucralose to Erythritol Ratio | 0.02 Urinary Sucralose/Erythritol (mg/m | Standard Deviation 0.01 |
| Lean - Placebo | Gut Permeability - Sucralose to Erythritol Ratio | 0.02 Urinary Sucralose/Erythritol (mg/m | Standard Deviation 0.004 |
| Obese - Placebo | Gut Permeability - Sucralose to Erythritol Ratio | 0.02 Urinary Sucralose/Erythritol (mg/m | Standard Deviation 0.004 |
Secondary
Gut Permeability - Sucralose to Erythritol Ratio
Urinary Sucralose/Erythritol Ratio (mg/mg)
Time frame: Week 0 - 6-24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Gut Permeability - Sucralose to Erythritol Ratio | 0.02 Urinary Sucralose/Erythritol (mg/mg) | Standard Deviation 0.01 |
| Obese - GTE | Gut Permeability - Sucralose to Erythritol Ratio | 0.02 Urinary Sucralose/Erythritol (mg/mg) | Standard Deviation 0.01 |
| Lean - Placebo | Gut Permeability - Sucralose to Erythritol Ratio | 0.02 Urinary Sucralose/Erythritol (mg/mg) | Standard Deviation 0.01 |
| Obese - Placebo | Gut Permeability - Sucralose to Erythritol Ratio | 0.02 Urinary Sucralose/Erythritol (mg/mg) | Standard Deviation 0.01 |
Secondary
Gut Permeability - Sucralose to Erythritol Ratio
Urinary Sucralose/Erythritol Ratio (mg/mg)
Time frame: Week 4 - 0-24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Gut Permeability - Sucralose to Erythritol Ratio | 0.01 Urinary Sucralose/Erythritol (mg/m | Standard Deviation 0.02 |
| Obese - GTE | Gut Permeability - Sucralose to Erythritol Ratio | 0.02 Urinary Sucralose/Erythritol (mg/m | Standard Deviation 0.01 |
| Lean - Placebo | Gut Permeability - Sucralose to Erythritol Ratio | 0.02 Urinary Sucralose/Erythritol (mg/m | Standard Deviation 0.01 |
| Obese - Placebo | Gut Permeability - Sucralose to Erythritol Ratio | 0.02 Urinary Sucralose/Erythritol (mg/m | Standard Deviation 0.01 |
Secondary
Tmax of Epicatechin
Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Population: A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Tmax of Epicatechin | 1.66 h | Standard Error 0.24 |
| Obese - GTE | Tmax of Epicatechin | 1.53 h | Standard Error 0.19 |
Secondary
Tmax of Epicatechin Gallate
Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Population: A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Tmax of Epicatechin Gallate | 4.05 h | Standard Error 0.24 |
| Obese - GTE | Tmax of Epicatechin Gallate | 3.94 h | Standard Error 0.39 |
Secondary
Tmax of Epigallocatechin
Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Population: A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Tmax of Epigallocatechin | 1.92 h | Standard Error 0.25 |
| Obese - GTE | Tmax of Epigallocatechin | 1.41 h | Standard Error 0.15 |
Secondary
Tmax of Epigallocatechin Gallate
Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Population: A pharmacokinetics study was completed regarding catechin bioavailability in all participants prior to the intervention randomization of treatment (GTE/Placebo). During this phase, all lean and obese participants of both groups consumed green tea extract containing confection. Bioavailability measures were then performed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Tmax of Epigallocatechin Gallate | 3.32 h | Standard Error 0.25 |
| Obese - GTE | Tmax of Epigallocatechin Gallate | 2.65 h | Standard Error 0.26 |
Secondary
Urinary Sucralose/Erythritol Ratio (mg/mg)
Ratio of excretion of urinary sugars (Sucralose to Erythritol)
Time frame: Week 4 - 6-24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lean - GTE | Urinary Sucralose/Erythritol Ratio (mg/mg) | 0.01 Urinary Sucralose/Erythritol (mg/m | Standard Deviation 0.01 |
| Obese - GTE | Urinary Sucralose/Erythritol Ratio (mg/mg) | 0.01 Urinary Sucralose/Erythritol (mg/m | Standard Deviation 0.01 |
| Lean - Placebo | Urinary Sucralose/Erythritol Ratio (mg/mg) | 0.02 Urinary Sucralose/Erythritol (mg/m | Standard Deviation 0.01 |
| Obese - Placebo | Urinary Sucralose/Erythritol Ratio (mg/mg) | 0.02 Urinary Sucralose/Erythritol (mg/m | Standard Deviation 0.02 |