Trial Outcomes & Findings for Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults (NCT NCT03413735)

Results Overview

Serum endotoxin concentration

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Week 0 - Fasting

Results posted on

2025-06-13

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Lean - Placebo 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	Lean - GTE 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	Obese - Placebo 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	Obese - GTE 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
Pharmacokinetic Study STARTED	10	10	10	10
Pharmacokinetic Study COMPLETED	10	10	10	10
Pharmacokinetic Study NOT COMPLETED	0	0	0	0
Randomized Controlled Trial STARTED	10	10	10	10
Randomized Controlled Trial COMPLETED	10	10	9	10
Randomized Controlled Trial NOT COMPLETED	0	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Confection n=20 Participants 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	Green Tea Extract-Confection n=20 Participants 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	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=20 Participants	20 Participants n=20 Participants	40 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Continuous	28. years STANDARD_DEVIATION 6.48 • n=20 Participants	28.35 years STANDARD_DEVIATION 9.04 • n=20 Participants	28.175 years STANDARD_DEVIATION 7.77 • n=40 Participants
Sex: Female, Male Female	12 Participants n=20 Participants	8 Participants n=20 Participants	20 Participants n=40 Participants
Sex: Female, Male Male	8 Participants n=20 Participants	12 Participants n=20 Participants	20 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	20 participants n=20 Participants	20 participants n=20 Participants	40 participants n=40 Participants

PRIMARY outcome

Timeframe: Week 0 - Fasting

Serum endotoxin concentration

Outcome measures

Outcome measures
Measure	Obese n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean - Placebo n=10 Participants Participants consumed gelatin extract with no green tea extract.	Obese - Placebo n=10 Participants Participants consumed gelatin extract with no green tea extract.
Endotoxin	12.97 EU/mL Standard Deviation 6.44	14.44 EU/mL Standard Deviation 4.46	12.25 EU/mL Standard Deviation 6.05	17.65 EU/mL Standard Deviation 12.58

PRIMARY outcome

Timeframe: Week 2 - Fasting

Serum endotoxin concentration

Outcome measures

Outcome measures
Measure	Obese n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean - Placebo n=10 Participants Participants consumed gelatin extract with no green tea extract.	Obese - Placebo n=10 Participants Participants consumed gelatin extract with no green tea extract.
Endotoxin	12.38 EU/mL Standard Deviation 7.53	13.59 EU/mL Standard Deviation 7.38	13.00 EU/mL Standard Deviation 5.44	15.62 EU/mL Standard Deviation 5.32

PRIMARY outcome

Timeframe: Week 4 - Fasting

Serum endotoxin concentration

Outcome measures

Outcome measures
Measure	Obese n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean - Placebo n=10 Participants Participants consumed gelatin extract with no green tea extract.	Obese - Placebo n=10 Participants Participants consumed gelatin extract with no green tea extract.
Endotoxin	16.46 EU/mL Standard Deviation 4.91	12.33 EU/mL Standard Deviation 4.55	11.33 EU/mL Standard Deviation 5.56	15.45 EU/mL Standard Deviation 6.94

SECONDARY outcome

Timeframe: Week 0 - 0-5 hours

Urinary Lactulose/Mannitol Ratio (mg/mg)

Outcome measures

Outcome measures
Measure	Obese n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean - Placebo n=10 Participants Participants consumed gelatin extract with no green tea extract.	Obese - Placebo n=9 Participants Participants consumed gelatin extract with no green tea extract.
Gut Permeability - Lactulose to Mannitol Ratio	0.09 Ratio Standard Deviation 0.03	0.12 Ratio Standard Deviation 0.06	0.10 Ratio Standard Deviation 0.05	0.10 Ratio Standard Deviation 0.03

SECONDARY outcome

Timeframe: Week 0 - 6-24 hours

Urinary Lactulose/Mannitol Ratio (mg/mg)

Outcome measures

Outcome measures
Measure	Obese n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean - Placebo n=10 Participants Participants consumed gelatin extract with no green tea extract.	Obese - Placebo n=9 Participants Participants consumed gelatin extract with no green tea extract.
Gut Permeability - Lactulose to Mannitol Ratio	0.11 Urinary Lactulose/Mannitol Ratio (mg/mg) Standard Deviation 0.10	0.16 Urinary Lactulose/Mannitol Ratio (mg/mg) Standard Deviation 0.10	0.19 Urinary Lactulose/Mannitol Ratio (mg/mg) Standard Deviation 0.12	0.19 Urinary Lactulose/Mannitol Ratio (mg/mg) Standard Deviation 0.14

SECONDARY outcome

Timeframe: Week 4 - 0-5 hours

Urinary Lactulose/Mannitol Ratio (mg/mg)

Outcome measures

Outcome measures
Measure	Obese n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean - Placebo n=10 Participants Participants consumed gelatin extract with no green tea extract.	Obese - Placebo n=9 Participants Participants consumed gelatin extract with no green tea extract.
Gut Permeability - Lactulose to Mannitol Ratio	0.14 Urinary Lactulose/Mannitol Ratio (mg/mg) Standard Deviation 0.10	0.12 Urinary Lactulose/Mannitol Ratio (mg/mg) Standard Deviation 0.13	0.10 Urinary Lactulose/Mannitol Ratio (mg/mg) Standard Deviation 0.06	0.12 Urinary Lactulose/Mannitol Ratio (mg/mg) Standard Deviation 0.08

SECONDARY outcome

Timeframe: Week 4 - 6-24 hours

Urinary Lactulose/Mannitol Ratio (mg/mg)

Outcome measures

Outcome measures
Measure	Obese n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean - Placebo n=10 Participants Participants consumed gelatin extract with no green tea extract.	Obese - Placebo n=9 Participants Participants consumed gelatin extract with no green tea extract.
Gut Permeability - Lactulose to Mannitol Ratio	0.18 Urinary Lactulose/Mannitol Ratio (mg/mg) Standard Deviation 0.18	0.14 Urinary Lactulose/Mannitol Ratio (mg/mg) Standard Deviation 0.11	0.19 Urinary Lactulose/Mannitol Ratio (mg/mg) Standard Deviation 0.12	0.21 Urinary Lactulose/Mannitol Ratio (mg/mg) Standard Deviation 0.12

SECONDARY outcome

Timeframe: Week 0 - 6-24 hours

Urinary Sucralose/Erythritol Ratio (mg/mg)

Outcome measures

Outcome measures
Measure	Obese n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean - Placebo n=10 Participants Participants consumed gelatin extract with no green tea extract.	Obese - Placebo n=9 Participants Participants consumed gelatin extract with no green tea extract.
Gut Permeability - Sucralose to Erythritol Ratio	0.02 Urinary Sucralose/Erythritol (mg/mg) Standard Deviation 0.01	0.02 Urinary Sucralose/Erythritol (mg/mg) Standard Deviation 0.01	0.02 Urinary Sucralose/Erythritol (mg/mg) Standard Deviation 0.01	0.02 Urinary Sucralose/Erythritol (mg/mg) Standard Deviation 0.01

SECONDARY outcome

Timeframe: Week 0 - 0-24 hours

Urinary Sucralose/Erythritol Ratio (mg/mg)

Outcome measures

Outcome measures
Measure	Obese n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean - Placebo n=10 Participants Participants consumed gelatin extract with no green tea extract.	Obese - Placebo n=9 Participants Participants consumed gelatin extract with no green tea extract.
Gut Permeability - Sucralose to Erythritol Ratio	0.02 Urinary Sucralose/Erythritol (mg/m Standard Deviation 0.01	0.02 Urinary Sucralose/Erythritol (mg/m Standard Deviation 0.01	0.02 Urinary Sucralose/Erythritol (mg/m Standard Deviation 0.004	0.02 Urinary Sucralose/Erythritol (mg/m Standard Deviation 0.004

SECONDARY outcome

Timeframe: Week 4 - 6-24 hours

Ratio of excretion of urinary sugars (Sucralose to Erythritol)

Outcome measures

Outcome measures
Measure	Obese n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean - Placebo n=10 Participants Participants consumed gelatin extract with no green tea extract.	Obese - Placebo n=9 Participants Participants consumed gelatin extract with no green tea extract.
Urinary Sucralose/Erythritol Ratio (mg/mg)	0.01 Urinary Sucralose/Erythritol (mg/m Standard Deviation 0.01	0.01 Urinary Sucralose/Erythritol (mg/m Standard Deviation 0.01	0.02 Urinary Sucralose/Erythritol (mg/m Standard Deviation 0.01	0.02 Urinary Sucralose/Erythritol (mg/m Standard Deviation 0.02

SECONDARY outcome

Timeframe: Week 4 - 0-24 hours

Urinary Sucralose/Erythritol Ratio (mg/mg)

Outcome measures

Outcome measures
Measure	Obese n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean - Placebo n=10 Participants Participants consumed gelatin extract with no green tea extract.	Obese - Placebo n=9 Participants Participants consumed gelatin extract with no green tea extract.
Gut Permeability - Sucralose to Erythritol Ratio	0.02 Urinary Sucralose/Erythritol (mg/m Standard Deviation 0.01	0.01 Urinary Sucralose/Erythritol (mg/m Standard Deviation 0.02	0.02 Urinary Sucralose/Erythritol (mg/m Standard Deviation 0.01	0.02 Urinary Sucralose/Erythritol (mg/m Standard Deviation 0.01

SECONDARY outcome

Timeframe: Week 0

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

Outcome measures

Outcome measures
Measure	Obese n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean - Placebo n=10 Participants Participants consumed gelatin extract with no green tea extract.	Obese - Placebo n=9 Participants Participants consumed gelatin extract with no green tea extract.
Firmicutes to Bacteroidetes Ratio - Microbiota	3.52 % of abundance Standard Deviation 2.32	4.34 % of abundance Standard Deviation 3.17	21.51 % of abundance Standard Deviation 31.65	9.36 % of abundance Standard Deviation 7.48

SECONDARY outcome

Timeframe: Week 4

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

Outcome measures

Outcome measures
Measure	Obese n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean n=10 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean - Placebo n=10 Participants Participants consumed gelatin extract with no green tea extract.	Obese - Placebo n=9 Participants Participants consumed gelatin extract with no green tea extract.
Firmicutes to Bacteroidetes Ratio - Microbiota	8.95 ratio Standard Deviation 15.13	4.90 ratio Standard Deviation 3.74	4.69 ratio Standard Deviation 4.17	9.32 ratio Standard Deviation 3.95

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Obese n=17 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean n=19 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean - Placebo Participants consumed gelatin extract with no green tea extract.	Obese - Placebo Participants consumed gelatin extract with no green tea extract.
Bioavailability - Epigallocatechin Gallate	2.62 umol/L x h Standard Error 0.3	3.46 umol/L x h Standard Error 0.3	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Obese n=17 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean n=19 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean - Placebo Participants consumed gelatin extract with no green tea extract.	Obese - Placebo Participants consumed gelatin extract with no green tea extract.
Bioavailability - Epigallocatechin	0.88 umol/L x h Standard Error 0.1	1.18 umol/L x h Standard Error 0.1	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Obese n=17 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean n=19 Participants Participants consumed green tea extract containing confection (50 g 114 confection containing 0.5 g GTE) without any additional foods, except water (500 mL).	Lean - Placebo Participants consumed gelatin extract with no green tea extract.	Obese - Placebo Participants consumed gelatin extract with no green tea extract.
Bioavailability - Epicatechin Gallate	0.78 umol/L x h Standard Error 0.1	1.06 umol/L x h Standard Error 0.1	—	—

SECONDARY outcome

Timeframe: 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.

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.