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出境医 / 临床实验 / Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome

Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome

Study Description
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.

Condition or disease Intervention/treatment Phase
Dysbiosis Endotoxemia Metabolic Syndrome Inflammation Dietary Supplement: Green Tea Extract Dietary Supplement: Placebo Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : March 1, 2021
Actual Study Completion Date : March 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Green Tea
Participants consuming gummy confections with catechin-rich green tea extract daily for 4 weeks
 Dietary Supplement: Green Tea Extract
A gummy confection with catechin-rich green tea extract (1 g/d)
Other Name: Camellia sinesis plant extract
Placebo Comparator: Placebo
Participants consuming matched gummy confections formulated without green tea extract daily for 4 weeks
 Dietary Supplement: Placebo
A matched gummy confection formulated without green tea extract
Outcome Measures
Primary Outcome Measures :
  1. Change in metabolic endotoxemia [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Serum endotoxin concentration (EU/mL) will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.


Secondary Outcome Measures :
  1. Gastrointestinal permeability [ Time Frame: Day 28 of the 28-day intervention ]
    Lactulose/mannitol ratio will be measured in urine collected 0-5 h post-ingestion to assess small intestinal permeability. Sucralose (%) will be measured in urine collected 0-24 h post-ingestion to assess colonic permeability. Between-treatment differences will be measured in MetS vs. healthy individuals.

  2. Plasma inflammatory biomarker: C-reactive protein [ Time Frame: Day 28 of the 28-day intervention ]
    Plasma concentration (mg/L) of C-reactive protein will be measured at the end of each treatment. Between-treatment differences will be measured in MetS vs. healthy individuals.

  3. Plasma inflammatory biomarkers: interleukin-6, interleukin-8, and tumor necrosis factor alpha [ Time Frame: Day 28 of the 28-day intervention ]
    Plasma concentrations (pg/mL) of interleukin-6, interleukin-8, and tumor necrosis factor alpha will be measured individually at the end of each treatment. Between-treatment differences will be measured in MetS vs. healthy individuals.

  4. Plasma inflammatory biomarker: myeloperoxidase [ Time Frame: Day 28 of the 28-day intervention ]
    Plasma concentration (ng/mL) of myeloperoxidase will be measured at the end of each treatment. Between-treatment differences will be measured in MetS vs. healthy individuals.

  5. Pro-inflammatory gene expression from peripheral blood mononuclear cells [ Time Frame: Day 28 of the 28-day intervention ]
    Relative expression of toll-like receptor 4, myeloid differentiation factor 88, p65 subunit of NF-kappa B, interleukin-6, interleukin-8, tumor necrosis factor alpha, and monocyte chemoattractant protein-1 will be measured individually at the end of each treatment. Between-treatment differences will be measured in MetS vs. healthy individuals.

  6. Intestinal inflammatory biomarker: calprotectin [ Time Frame: Days 25-27 of the 28-day intervention ]
    Fecal concentration (μg/g) of calprotectin will be measured in samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.

  7. Intestinal inflammatory biomarker: myeloperoxidase [ Time Frame: Days 25-27 of the 28-day intervention ]
    Fecal concentration (ng/g) of myeloperoxidase will be measured in samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.

  8. Changes in plasma catechins and their metabolites [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Plasma concentrations (nmol/L) of epigallocatechin gallate, epicatechin gallate, epigallocatechin, epicatechin, gamma-valerolactones, and catechin-derivates will be measured individually at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.

  9. Fecal catechins and their metabolites [ Time Frame: Days 25-27 of the 28-day intervention ]
    Fecal concentrations (μmol/kg) of epigallocatechin gallate, epicatechin gallate, epigallocatechin, epicatechin, gamma-valerolactones, and catechin-derivates will be measured individually in samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.

  10. Fecal short-chain fatty acids [ Time Frame: Days 25-27 of the 28-day intervention ]
    Fecal concentrations (mmol/kg) of butyrate, acetate, propionate, isobutyric acid, and isovaleric acid will be measured individually in samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.

  11. Gut microbiota diversity indices [ Time Frame: Days 25-27 of the 28-day intervention ]
    Gut microbiota diversity indices (Shannon species and Chao1) will be measured in fecal samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.

  12. Gut microbiota Firmicutes/Bacteroidetes ratio [ Time Frame: Days 25-27 of the 28-day intervention ]
    Gut microbiota Firmicutes/Bacteroidetes ratio will be measured in fecal samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.

  13. Gut microbiota relative abundance [ Time Frame: Days 25-27 of the 28-day intervention ]
    Gut microbiota relative abundance (% order, genus, and species level) will be measured in fecal samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.

  14. Gut microbiota function proportions [ Time Frame: Days 25-27 of the 28-day intervention ]
    Gut microbiota function proportions (%) based on microbial genome analysis will be measured in fecal samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.

  15. Change in plasma glucose [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Plasma concentration (mg/dL) of glucose will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.

  16. Change in plasma insulin [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Plasma concentration (μIU/mL) of insulin will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.

  17. Change in plasma lipids [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Plasma concentrations (mg/dL) of triglyceride and HDL-cholesterol will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.

  18. Changes in serum alanine transaminase and aspartate transaminase [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Serum concentrations (U/L) of alanine transaminase and aspartate transaminase will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.

  19. Changes in serum creatinine and blood urea nitrogen [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Serum concentrations (U/L) of creatinine and blood urea nitrogen will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.

  20. Change in blood hematocrit [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Blood hematocrit (%) will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
Layout table for location information
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
USDA Beltsville Human Nutrition Research Center
Investigators
Layout table for investigator information
Principal Investigator: Richard S Bruno, PhD, RD Ohio State University
Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date April 19, 2021
Actual Study Start Date  ICMJE July 1, 2019
Actual Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019) 		Change in metabolic endotoxemia [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
Serum endotoxin concentration (EU/mL) will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Gastrointestinal permeability [ Time Frame: Day 28 of the 28-day intervention ]
    Lactulose/mannitol ratio will be measured in urine collected 0-5 h post-ingestion to assess small intestinal permeability. Sucralose (%) will be measured in urine collected 0-24 h post-ingestion to assess colonic permeability. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Plasma inflammatory biomarker: C-reactive protein [ Time Frame: Day 28 of the 28-day intervention ]
    Plasma concentration (mg/L) of C-reactive protein will be measured at the end of each treatment. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Plasma inflammatory biomarkers: interleukin-6, interleukin-8, and tumor necrosis factor alpha [ Time Frame: Day 28 of the 28-day intervention ]
    Plasma concentrations (pg/mL) of interleukin-6, interleukin-8, and tumor necrosis factor alpha will be measured individually at the end of each treatment. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Plasma inflammatory biomarker: myeloperoxidase [ Time Frame: Day 28 of the 28-day intervention ]
    Plasma concentration (ng/mL) of myeloperoxidase will be measured at the end of each treatment. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Pro-inflammatory gene expression from peripheral blood mononuclear cells [ Time Frame: Day 28 of the 28-day intervention ]
    Relative expression of toll-like receptor 4, myeloid differentiation factor 88, p65 subunit of NF-kappa B, interleukin-6, interleukin-8, tumor necrosis factor alpha, and monocyte chemoattractant protein-1 will be measured individually at the end of each treatment. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Intestinal inflammatory biomarker: calprotectin [ Time Frame: Days 25-27 of the 28-day intervention ]
    Fecal concentration (μg/g) of calprotectin will be measured in samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Intestinal inflammatory biomarker: myeloperoxidase [ Time Frame: Days 25-27 of the 28-day intervention ]
    Fecal concentration (ng/g) of myeloperoxidase will be measured in samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Changes in plasma catechins and their metabolites [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Plasma concentrations (nmol/L) of epigallocatechin gallate, epicatechin gallate, epigallocatechin, epicatechin, gamma-valerolactones, and catechin-derivates will be measured individually at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
  • Fecal catechins and their metabolites [ Time Frame: Days 25-27 of the 28-day intervention ]
    Fecal concentrations (μmol/kg) of epigallocatechin gallate, epicatechin gallate, epigallocatechin, epicatechin, gamma-valerolactones, and catechin-derivates will be measured individually in samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Fecal short-chain fatty acids [ Time Frame: Days 25-27 of the 28-day intervention ]
    Fecal concentrations (mmol/kg) of butyrate, acetate, propionate, isobutyric acid, and isovaleric acid will be measured individually in samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Gut microbiota diversity indices [ Time Frame: Days 25-27 of the 28-day intervention ]
    Gut microbiota diversity indices (Shannon species and Chao1) will be measured in fecal samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Gut microbiota Firmicutes/Bacteroidetes ratio [ Time Frame: Days 25-27 of the 28-day intervention ]
    Gut microbiota Firmicutes/Bacteroidetes ratio will be measured in fecal samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Gut microbiota relative abundance [ Time Frame: Days 25-27 of the 28-day intervention ]
    Gut microbiota relative abundance (% order, genus, and species level) will be measured in fecal samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Gut microbiota function proportions [ Time Frame: Days 25-27 of the 28-day intervention ]
    Gut microbiota function proportions (%) based on microbial genome analysis will be measured in fecal samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Change in plasma glucose [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Plasma concentration (mg/dL) of glucose will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
  • Change in plasma insulin [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Plasma concentration (μIU/mL) of insulin will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
  • Change in plasma lipids [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Plasma concentrations (mg/dL) of triglyceride and HDL-cholesterol will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
  • Changes in serum alanine transaminase and aspartate transaminase [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Serum concentrations (U/L) of alanine transaminase and aspartate transaminase will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
  • Changes in serum creatinine and blood urea nitrogen [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Serum concentrations (U/L) of creatinine and blood urea nitrogen will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
  • Change in blood hematocrit [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Blood hematocrit (%) will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • Gastrointestinal permeability [ Time Frame: Day 28 of the 28-day intervention ]
    Lactulose/mannitol ratio will be measured in urine collected 0-5 h post-ingestion to assess small intestinal permeability. Sucralose (%) will be measured in urine collected 0-24 h post-ingestion to assess colonic permeability. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Plasma inflammatory biomarker: C-reactive protein [ Time Frame: Day 28 of the 28-day intervention ]
    Plasma concentration (mg/L) of C-reactive protein will be measured at the end of each treatment. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Plasma inflammatory biomarkers: interleukin-6, interleukin-8, and tumor necrosis factor alpha [ Time Frame: Day 28 of the 28-day intervention ]
    Plasma concentrations (pg/mL) of interleukin-6, interleukin-8, and tumor necrosis factor alpha will be measured individually at the end of each treatment. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Plasma inflammatory biomarker: myeloperoxidase [ Time Frame: Day 28 of the 28-day intervention ]
    Plasma concentration (ng/mL) of myeloperoxidase will be measured at the end of each treatment. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Pro-inflammatory gene expression from peripheral blood mononuclear cells [ Time Frame: Day 28 of the 28-day intervention ]
    Relative expression of toll-like receptor 4, myeloid differentiation factor 88, p65 subunit of NF-kappa B, interleukin-6, interleukin-8, tumor necrosis factor alpha, and monocyte chemoattractant protein-1 will be measured individually at the end of each treatment. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Intestinal inflammatory biomarker: calprotectin [ Time Frame: Days 25-27 of the 28-day intervention ]
    Fecal concentration (μg/g) of calprotectin will be measured in samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Intestinal inflammatory biomarker: myeloperoxidase [ Time Frame: Days 25-27 of the 28-day intervention ]
    Fecal concentration (ng/g) of myeloperoxidase will be measured in samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Changes in plasma catechins and their metabolites [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Plasma concentrations (nmol/L) of epigallocatechin gallate, epicatechin gallate, epigallocatechin, epicatechin, gamma-valerolactones, and catechin-derivates will be measured individually at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
  • Fecal catechins and their metabolites [ Time Frame: Days 25-27 of the 28-day intervention ]
    Fecal concentrations (μmol/kg) of epigallocatechin gallate, epicatechin gallate, epigallocatechin, epicatechin, gamma-valerolactones, and catechin-derivates will be measured individually in samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Fecal short-chain fatty acids [ Time Frame: Days 25-27 of the 28-day intervention ]
    Fecal concentrations (mmol/kg) of butyrate, acetate, propionate, isobutyric acid, and isovaleric acid will be measured individually in samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Gut microbiota diversity indices [ Time Frame: Days 25-27 of the 28-day intervention ]
    Gut microbiota diversity indices (Shannon species and Chao1) will be measured in fecal samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Gut microbiota Firmicutes/Bacteroidetes ratio [ Time Frame: Days 25-27 of the 28-day intervention ]
    Gut microbiota Firmicutes/Bacteroidetes ratio will be measured in fecal samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Gut microbiota relative abundance [ Time Frame: Days 25-27 of the 28-day intervention ]
    Gut microbiota relative abundance (% order, genus, and species level) will be measured in fecal samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Gut microbiota function proportions [ Time Frame: Days 25-27 of the 28-day intervention ]
    Gut microbiota function proportions (%) based on microbial genome analysis will be measured in fecal samples collected over 3 consecutive days and pooled prior to analysis. Between-treatment differences will be measured in MetS vs. healthy individuals.
  • Change in serum glucose [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Serum concentration (mg/dL) of glucose will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
  • Change in serum insulin [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Serum concentration (μIU/mL) of insulin will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
  • Change in serum lipids [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Serum concentrations (mg/dL) of triglyceride and HDL-cholesterol will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
  • Changes in serum alanine transaminase and aspartate transaminase [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Serum concentrations (U/L) of alanine transaminase and aspartate transaminase will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
  • Changes in serum creatinine and blood urea nitrogen [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Serum concentrations (U/L) of creatinine and blood urea nitrogen will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
  • Change in red blood cell, white blood cell, and platelet count [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Counts (cells/cumm) of red blood cells, white blood cells, and platelets will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
  • Change in blood hemoglobin [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Blood concentration (g/dL) of hemoglobin will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
  • Change in blood hematocrit [ Time Frame: Day 0, 14, and 28 of the 28-day intervention ]
    Blood hematocrit (%) will be measured at the beginning, in the middle, and at the end of each treatment. Time-dependent changes relative to baseline (day 0) in each treatment and between-treatment differences will be measured in MetS vs. healthy individuals.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome
Official Title  ICMJE Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Dysbiosis
  • Endotoxemia
  • Metabolic Syndrome
  • Inflammation
Intervention  ICMJE
  • Dietary Supplement: Green Tea Extract
    A gummy confection with catechin-rich green tea extract (1 g/d)
    Other Name: Camellia sinesis plant extract
  • Dietary Supplement: Placebo
    A matched gummy confection formulated without green tea extract
Study Arms  ICMJE
  • Experimental: Green Tea
    Participants consuming gummy confections with catechin-rich green tea extract daily for 4 weeks
    Intervention: Dietary Supplement: Green Tea Extract
  • Placebo Comparator: Placebo
    Participants consuming matched gummy confections formulated without green tea extract daily for 4 weeks
    Intervention: Dietary Supplement: Placebo
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.
  • Li J, Sasaki GY, Dey P, Chitchumroonchokchai C, Labyk AN, McDonald JD, Kim JB, Bruno RS. Green tea extract protects against hepatic NFκB 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2021
Actual Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03973996
Other Study ID Numbers  ICMJE 2018H0592
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Richard Bruno, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE USDA Beltsville Human Nutrition Research Center
Investigators  ICMJE
Principal Investigator: Richard S Bruno, PhD, RD Ohio State University
PRS Account Ohio State University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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