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CompletedNCT03413735Updated Jun 13, 2025Results posted

Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults

An interventional study of Green Tea Extract and Placebo in Obesity, Endotoxemia and Inflammation, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by Ohio State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity
  • Endotoxemia
  • Inflammation
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Placebo comparator
    Placebo Confection

    Confection without green tea extract consumed daily for 4 weeks

    Other: Placebo

  • Experimental
    Green Tea Extract-Confection

    Confection with green tea extract consumed daily for 4 weeks

    Other: Green Tea Extract

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

05

What researchers measure

Primary outcomes

  1. Endotoxin

    Serum endotoxin concentration

    Time frame: Week 0 - Fasting

  2. Endotoxin

    Serum endotoxin concentration

    Time frame: Week 2 - Fasting

  3. Endotoxin

    Serum endotoxin concentration

    Time frame: Week 4 - Fasting

Secondary outcomes

  1. Gut Permeability - Lactulose to Mannitol Ratio

    Urinary Lactulose/Mannitol Ratio (mg/mg)

    Time frame: Week 0 - 0-5 hours

  2. Gut Permeability - Lactulose to Mannitol Ratio

    Urinary Lactulose/Mannitol Ratio (mg/mg)

    Time frame: Week 0 - 6-24 hours

  3. Gut Permeability - Lactulose to Mannitol Ratio

    Urinary Lactulose/Mannitol Ratio (mg/mg)

    Time frame: Week 4 - 0-5 hours

  4. Gut Permeability - Lactulose to Mannitol Ratio

    Urinary Lactulose/Mannitol Ratio (mg/mg)

    Time frame: Week 4 - 6-24 hours

  5. Gut Permeability - Sucralose to Erythritol Ratio

    Urinary Sucralose/Erythritol Ratio (mg/mg)

    Time frame: Week 0 - 6-24 hours

  6. Gut Permeability - Sucralose to Erythritol Ratio

    Urinary Sucralose/Erythritol Ratio (mg/mg)

    Time frame: Week 0 - 0-24 hours

  7. Urinary Sucralose/Erythritol Ratio (mg/mg)

    Ratio of excretion of urinary sugars (Sucralose to Erythritol)

    Time frame: Week 4 - 6-24 hours

  8. Gut Permeability - Sucralose to Erythritol Ratio

    Urinary Sucralose/Erythritol Ratio (mg/mg)

    Time frame: Week 4 - 0-24 hours

  9. Firmicutes to Bacteroidetes Ratio - Microbiota

    Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)

    Time frame: Week 0

  10. Firmicutes to Bacteroidetes Ratio - Microbiota

    Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)

    Time frame: Week 4

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. Calprotectin

    Fecal calprotectin concentration

    Time frame: Week 0

  24. Calprotectin

    Fecal calprotectin concentration

    Time frame: Week 4

06

Results

Posted Jun 13, 2025

Participant flow

Pharmacokinetic Study
Participant flow — Pharmacokinetic Study
MilestoneLean - PlaceboLean - GTEObese - PlaceboObese - GTE
Started10101010
Completed10101010
Not completed0000
Randomized Controlled Trial
Participant flow — Randomized Controlled Trial
MilestoneLean - PlaceboLean - GTEObese - PlaceboObese - GTE
Started10101010
Completed1010910
Not completed0010

Outcome measures

PrimaryEndotoxin

Serum endotoxin concentration

Time frame:
Week 0 - Fasting
Reported as:
Mean · EU/mL
Endotoxin
EU/mLLean - GTEObese - GTELean - PlaceboObese - Placebo
Endotoxin14.44 ± 4.4612.97 ± 6.4412.25 ± 6.0517.65 ± 12.58
PrimaryEndotoxin

Serum endotoxin concentration

Time frame:
Week 2 - Fasting
Reported as:
Mean · EU/mL
Endotoxin
EU/mLLean - GTEObese - GTELean - PlaceboObese - Placebo
Endotoxin13.59 ± 7.3812.38 ± 7.5313.00 ± 5.4415.62 ± 5.32
PrimaryEndotoxin

Serum endotoxin concentration

Time frame:
Week 4 - Fasting
Reported as:
Mean · EU/mL
Endotoxin
EU/mLLeanObeseLean - PlaceboObese - Placebo
Endotoxin12.33 ± 4.5516.46 ± 4.9111.33 ± 5.5615.45 ± 6.94
SecondaryGut Permeability - Lactulose to Mannitol Ratio

Urinary Lactulose/Mannitol Ratio (mg/mg)

Time frame:
Week 0 - 0-5 hours
Reported as:
Mean · Ratio
Gut Permeability - Lactulose to Mannitol Ratio
RatioLean - GTEObese - GTELean - PlaceboObese - Placebo
Gut Permeability - Lactulose to Mannitol Ratio0.12 ± 0.060.09 ± 0.030.10 ± 0.050.10 ± 0.03
SecondaryGut Permeability - Lactulose to Mannitol Ratio

Urinary Lactulose/Mannitol Ratio (mg/mg)

Time frame:
Week 0 - 6-24 hours
Reported as:
Mean · Urinary Lactulose/Mannitol Ratio (mg/mg)
Gut Permeability - Lactulose to Mannitol Ratio
Urinary Lactulose/Mannitol Ratio (mg/mg)Lean - GTEObese - GTELean - PlaceboObese - Placebo
Gut Permeability - Lactulose to Mannitol Ratio0.16 ± 0.100.11 ± 0.100.19 ± 0.120.19 ± 0.14
SecondaryGut Permeability - Lactulose to Mannitol Ratio

Urinary Lactulose/Mannitol Ratio (mg/mg)

Time frame:
Week 4 - 0-5 hours
Reported as:
Mean · Urinary Lactulose/Mannitol Ratio (mg/mg)
Gut Permeability - Lactulose to Mannitol Ratio
Urinary Lactulose/Mannitol Ratio (mg/mg)Lean - GTEObese - GTELean - PlaceboObese - Placebo
Gut Permeability - Lactulose to Mannitol Ratio0.12 ± 0.130.14 ± 0.100.10 ± 0.060.12 ± 0.08
SecondaryGut Permeability - Lactulose to Mannitol Ratio

Urinary Lactulose/Mannitol Ratio (mg/mg)

Time frame:
Week 4 - 6-24 hours
Reported as:
Mean · Urinary Lactulose/Mannitol Ratio (mg/mg)
Gut Permeability - Lactulose to Mannitol Ratio
Urinary Lactulose/Mannitol Ratio (mg/mg)Lean - GTEObese - GTELean - PlaceboObese - Placebo
Gut Permeability - Lactulose to Mannitol Ratio0.14 ± 0.110.18 ± 0.180.19 ± 0.120.21 ± 0.12
SecondaryGut Permeability - Sucralose to Erythritol Ratio

Urinary Sucralose/Erythritol Ratio (mg/mg)

Time frame:
Week 0 - 6-24 hours
Reported as:
Mean · Urinary Sucralose/Erythritol (mg/mg)
Gut Permeability - Sucralose to Erythritol Ratio
Urinary Sucralose/Erythritol (mg/mg)Lean - GTEObese - GTELean - PlaceboObese - Placebo
Gut Permeability - Sucralose to Erythritol Ratio0.02 ± 0.010.02 ± 0.010.02 ± 0.010.02 ± 0.01
SecondaryGut Permeability - Sucralose to Erythritol Ratio

Urinary Sucralose/Erythritol Ratio (mg/mg)

Time frame:
Week 0 - 0-24 hours
Reported as:
Mean · Urinary Sucralose/Erythritol (mg/m
Gut Permeability - Sucralose to Erythritol Ratio
Urinary Sucralose/Erythritol (mg/mLean - GTEObese - GTELean - PlaceboObese - Placebo
Gut Permeability - Sucralose to Erythritol Ratio0.02 ± 0.010.02 ± 0.010.02 ± 0.0040.02 ± 0.004
SecondaryUrinary Sucralose/Erythritol Ratio (mg/mg)

Ratio of excretion of urinary sugars (Sucralose to Erythritol)

Time frame:
Week 4 - 6-24 hours
Reported as:
Mean · Urinary Sucralose/Erythritol (mg/m
Urinary Sucralose/Erythritol Ratio (mg/mg)
Urinary Sucralose/Erythritol (mg/mLean - GTEObese - GTELean - PlaceboObese - Placebo
Urinary Sucralose/Erythritol Ratio (mg/mg)0.01 ± 0.010.01 ± 0.010.02 ± 0.010.02 ± 0.02
SecondaryGut Permeability - Sucralose to Erythritol Ratio

Urinary Sucralose/Erythritol Ratio (mg/mg)

Time frame:
Week 4 - 0-24 hours
Reported as:
Mean · Urinary Sucralose/Erythritol (mg/m
Gut Permeability - Sucralose to Erythritol Ratio
Urinary Sucralose/Erythritol (mg/mLean - GTEObese - GTELean - PlaceboObese - Placebo
Gut Permeability - Sucralose to Erythritol Ratio0.01 ± 0.020.02 ± 0.010.02 ± 0.010.02 ± 0.01
SecondaryFirmicutes to Bacteroidetes Ratio - Microbiota

Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)

Time frame:
Week 0
Reported as:
Mean · % of abundance
Firmicutes to Bacteroidetes Ratio - Microbiota
% of abundanceLean - GTEObese - GTELean - PlaceboObese - Placebo
Firmicutes to Bacteroidetes Ratio - Microbiota4.34 ± 3.173.52 ± 2.3221.51 ± 31.659.36 ± 7.48
SecondaryFirmicutes to Bacteroidetes Ratio - Microbiota

Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)

Time frame:
Week 4
Reported as:
Mean · ratio
Firmicutes to Bacteroidetes Ratio - Microbiota
ratioLean - GTEObese - GTELean - PlaceboObese - Placebo
Firmicutes to Bacteroidetes Ratio - Microbiota4.90 ± 3.748.95 ± 15.134.69 ± 4.179.32 ± 3.95
SecondaryBioavailability - 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
Reported as:
Mean · umol/L x h
Bioavailability - Epigallocatechin Gallate
umol/L x hLeanObese
Bioavailability - Epigallocatechin Gallate3.46 ± 0.32.62 ± 0.3
SecondaryBioavailability - 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
Reported as:
Mean · umol/L x h
Bioavailability - Epigallocatechin
umol/L x hLeanObese
Bioavailability - Epigallocatechin1.18 ± 0.10.88 ± 0.1
SecondaryBioavailability - 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
Reported as:
Mean · umol/L x h
Bioavailability - Epicatechin Gallate
umol/L x hLeanObese
Bioavailability - Epicatechin Gallate1.06 ± 0.10.78 ± 0.1
SecondaryBioavailability - 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
Reported as:
Mean · umol/L x h
Bioavailability - Epicatechin
umol/L x hLeanObese
Bioavailability - Epicatechin0.78 ± 0.10.57 ± 0.04
SecondaryCmax 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
Reported as:
Mean · umol/L
Cmax of Epigallocatechin Gallate
umol/LLeanObese
Cmax of Epigallocatechin Gallate0.5 ± 0.040.38 ± 0.03
SecondaryCmax 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
Reported as:
Mean · umol/L
Cmax of Epigallocatechin
umol/LLeanObese
Cmax of Epigallocatechin0.22 ± 0.010.18 ± 0.01
SecondaryCmax 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
Reported as:
Mean · umol/L
Cmax of Epicatechin Gallate
umol/LLeanObese
Cmax of Epicatechin Gallate0.14 ± 0.010.09 ± 0.01
SecondaryCmax 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
Reported as:
Mean · umol/L
Cmax of Epicatechin
umol/LLeanObese
Cmax of Epicatechin0.16 ± 0.10.13 ± 0.1
SecondaryTmax 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
Reported as:
Mean · h
Tmax of Epigallocatechin Gallate
hLeanObese
Tmax of Epigallocatechin Gallate3.32 ± 0.252.65 ± 0.26
SecondaryTmax 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
Reported as:
Mean · h
Tmax of Epigallocatechin
hLeanObese
Tmax of Epigallocatechin1.92 ± 0.251.41 ± 0.15
SecondaryTmax 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
Reported as:
Mean · h
Tmax of Epicatechin Gallate
hLeanObese
Tmax of Epicatechin Gallate4.05 ± 0.243.94 ± 0.39
SecondaryTmax 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
Reported as:
Mean · h
Tmax of Epicatechin
hLeanObese
Tmax of Epicatechin1.66 ± 0.241.53 ± 0.19
SecondaryCalprotectin

Fecal calprotectin concentration

Time frame:
Week 0
Reported as:
Mean · ug/g
Calprotectin
ug/gLean - GTEObese - GTELean - PlaceboObese - Placebo
Calprotectin64.99 ± 79.0727.54 ± 20.5832.01 ± 25.5262.62 ± 90.84
SecondaryCalprotectin

Fecal calprotectin concentration

Time frame:
Week 4
Reported as:
Mean · ug/g
Calprotectin
ug/gLean - GTEObese - GTELean - PlaceboObese - Placebo
Calprotectin249.62 ± 590.2125.74 ± 13.9436.20 ± 24.1573.04 ± 103.90

Adverse events

Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lean - Placebo0/10 (0%)0/10 (0%)0/10 (0%)
Obese - Placebo0/9 (0%)0/9 (0%)0/9 (0%)
Lean - GTE0/10 (0%)0/10 (0%)0/10 (0%)
Obese - GTE0/10 (0%)0/10 (0%)0/10 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Placebo ConfectionGreen Tea Extract-ConfectionTotal
<=18 years000
Between 18 and 65 years202040
>=65 years000
Age, Continuous
Age, Continuous(years)Placebo ConfectionGreen Tea Extract-ConfectionTotal
Mean28. ± 6.4828.35 ± 9.0428.175 ± 7.77
Sex: Female, Male
Sex: Female, Male(Participants)Placebo ConfectionGreen Tea Extract-ConfectionTotal
Female12820
Male81220
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Placebo ConfectionGreen Tea Extract-ConfectionTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Placebo ConfectionGreen Tea Extract-ConfectionTotal
United States202040
07

Study locations

1 site
  • Ohio State University
    Columbus, Ohio 43210, United States
08

References and documents

Publications

  • Li J, Sapper TN, Mah E, Moller MV, Kim JB, Chitchumroonchokchai C, McDonald JD, Bruno RS. Green tea extract treatment reduces NFkappaB activation in mice with diet-induced nonalcoholic steatohepatitis by lowering TNFR1 and TLR4 expression and ligand availability. J Nutr Biochem. 2017 Mar;41:34-41. doi: 10.1016/j.jnutbio.2016.12.007. Epub 2016 Dec 21. PubMed 28038359 ↗
  • Li J, Sasaki GY, Dey P, Chitchumroonchokchai C, Labyk AN, McDonald JD, Kim JB, Bruno RS. Green tea extract protects against hepatic NFkappaB activation along the gut-liver axis in diet-induced obese mice with nonalcoholic steatohepatitis by reducing endotoxin and TLR4/MyD88 signaling. J Nutr Biochem. 2018 Mar;53:58-65. doi: 10.1016/j.jnutbio.2017.10.016. Epub 2017 Nov 3. PubMed 29190550 ↗

Study documents

  • Protocol and statistical analysis plan · Nov 22, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Data will be published as aggregate only. Data sharing may be possible pending institutional agreements.

09

Registry details

Key details

Study ID
NCT03413735
Lead sponsor
Ohio State University
Responsible party
Richard Bruno (Professor, Ohio State University) — Principal investigator
First posted
Jan 29, 2018
Start date
Aug 29, 2018
Primary completion
Jul 30, 2019
Completion
Jul 30, 2019
Results posted
Jun 13, 2025
Last update
Jun 13, 2025

Study contacts

Richard Bruno, PhD, RD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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