Trial Outcomes & Findings for Gut-level Antiinflammatory Activities of Green Tea in Metabolic Syndrome (NCT NCT03973996)
NCT ID: NCT03973996
Last Updated: 2025-12-19
Results Overview
Data are biomarker fasting concentrations.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
Day 28
Results posted on
2025-12-19
Participant Flow
Participant milestones
| Measure |
Healthy - Placebo Then GTE
Participants with normal metabolic health will consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks, followed by a 4-week washout period, and then consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks.
|
MetS - GTE Then Placebo
Participants with metabolic syndrome will consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks, followed by a 4-week washout period, and then consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks.
|
Healthy- GTE Then Placebo
Participants with normal metabolic health will consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks, followed by a 4-week washout period, and then consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks.
|
MetS - Placebo Then GTE
Participants with metabolic syndrome will consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks, followed by a 4-week washout period, and then consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks.
|
|---|---|---|---|---|
|
First Intervention (4 Weeks)
STARTED
|
10
|
12
|
11
|
13
|
|
First Intervention (4 Weeks)
COMPLETED
|
9
|
11
|
10
|
10
|
|
First Intervention (4 Weeks)
NOT COMPLETED
|
1
|
1
|
1
|
3
|
|
Washout (4 Weeks)
STARTED
|
9
|
11
|
10
|
10
|
|
Washout (4 Weeks)
COMPLETED
|
9
|
11
|
10
|
10
|
|
Washout (4 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention (4 Weeks)
STARTED
|
9
|
11
|
10
|
10
|
|
Second Intervention (4 Weeks)
COMPLETED
|
9
|
11
|
10
|
10
|
|
Second Intervention (4 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Healthy - Placebo Then GTE
Participants with normal metabolic health will consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks, followed by a 4-week washout period, and then consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks.
|
MetS - GTE Then Placebo
Participants with metabolic syndrome will consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks, followed by a 4-week washout period, and then consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks.
|
Healthy- GTE Then Placebo
Participants with normal metabolic health will consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks, followed by a 4-week washout period, and then consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks.
|
MetS - Placebo Then GTE
Participants with metabolic syndrome will consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks, followed by a 4-week washout period, and then consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks.
|
|---|---|---|---|---|
|
First Intervention (4 Weeks)
Withdrawal by Subject
|
1
|
1
|
1
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy-Placebo Then GTE
n=9 Participants
Participants with normal metabolic health will consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks, followed by a 4-week washout period, and then consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks.
|
Healthy- GTE Then Placebo
n=10 Participants
Participants with normal metabolic health will consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks, followed by a 4-week washout period, and then consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks.
|
MetS- Placebo Then GTE
n=10 Participants
Participants with metabolic syndrome will consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks, followed by a 4-week washout period, and then consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 week
|
MetS- GTE Then Placebo
n=11 Participants
Participants with metabolic syndrome will consume catechin-rich green tea extract (1 g/day) gummy confections daily for 4 weeks, followed by a 4-week washout period, and then consume placebo gummy confections (formulated without green tea extract) daily for 4 weeks.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=9 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
11 Participants
n=11 Participants
|
40 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
7 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
8 Participants
n=11 Participants
|
25 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=11 Participants
|
15 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
|
9 participants
n=9 Participants
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
11 participants
n=11 Participants
|
40 participants
n=40 Participants
|
|
BMI
|
21.5 kg/m^2
STANDARD_DEVIATION 1.3 • n=9 Participants
|
23.1 kg/m^2
STANDARD_DEVIATION 2.1 • n=10 Participants
|
36.9 kg/m^2
STANDARD_DEVIATION 5.5 • n=10 Participants
|
33.7 kg/m^2
STANDARD_DEVIATION 3.2 • n=11 Participants
|
29.1 kg/m^2
STANDARD_DEVIATION 7.4 • n=40 Participants
|
|
Fasting blood glucose
|
87.1 mg/dL
STANDARD_DEVIATION 5.6 • n=9 Participants
|
91.0 mg/dL
STANDARD_DEVIATION 5.9 • n=10 Participants
|
105.0 mg/dL
STANDARD_DEVIATION 6.5 • n=10 Participants
|
100.2 mg/dL
STANDARD_DEVIATION 10.3 • n=11 Participants
|
96.1 mg/dL
STANDARD_DEVIATION 10.1 • n=40 Participants
|
|
Fasting triglycerides
|
47.2 mg/dL
STANDARD_DEVIATION 16.8 • n=9 Participants
|
73.5 mg/dL
STANDARD_DEVIATION 24.1 • n=10 Participants
|
132.7 mg/dL
STANDARD_DEVIATION 66.1 • n=10 Participants
|
199.5 mg/dL
STANDARD_DEVIATION 83.1 • n=11 Participants
|
117.0 mg/dL
STANDARD_DEVIATION 81.0 • n=40 Participants
|
|
Fasting HDL
|
64.3 mg/dL
STANDARD_DEVIATION 17.5 • n=9 Participants
|
59.2 mg/dL
STANDARD_DEVIATION 12.7 • n=10 Participants
|
42.3 mg/dL
STANDARD_DEVIATION 11.9 • n=10 Participants
|
36.1 mg/dL
STANDARD_DEVIATION 5.6 • n=11 Participants
|
49.7 mg/dL
STANDARD_DEVIATION 16.7 • n=40 Participants
|
|
Waist circumference
|
77.4 cm
STANDARD_DEVIATION 4.3 • n=9 Participants
|
79.1 cm
STANDARD_DEVIATION 6.9 • n=10 Participants
|
114.7 cm
STANDARD_DEVIATION 10.9 • n=10 Participants
|
109.6 cm
STANDARD_DEVIATION 12.4 • n=11 Participants
|
96.0 cm
STANDARD_DEVIATION 19.4 • n=40 Participants
|
|
Systolic Blood Pressure
|
115.4 mmHg
STANDARD_DEVIATION 5.8 • n=9 Participants
|
113.5 mmHg
STANDARD_DEVIATION 7.6 • n=10 Participants
|
125.5 mmHg
STANDARD_DEVIATION 7.6 • n=10 Participants
|
121.9 mmHg
STANDARD_DEVIATION 10.4 • n=11 Participants
|
119.3 mmHg
STANDARD_DEVIATION 9.2 • n=40 Participants
|
|
Diastolic Blood Pressure
|
74.6 mmHg
STANDARD_DEVIATION 3.5 • n=9 Participants
|
74.7 mmHg
STANDARD_DEVIATION 5.7 • n=10 Participants
|
85.0 mmHg
STANDARD_DEVIATION 8.1 • n=10 Participants
|
83.8 mmHg
STANDARD_DEVIATION 6.8 • n=11 Participants
|
79.8 mmHg
STANDARD_DEVIATION 7.8 • n=40 Participants
|
PRIMARY outcome
Timeframe: Day 28Data are biomarker fasting concentrations.
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Serum Endotoxin
|
31.6 EU/mL
Standard Error 2.5
|
26.7 EU/mL
Standard Error 2.6
|
44.5 EU/mL
Standard Error 2.4
|
39.1 EU/mL
Standard Error 2.5
|
SECONDARY outcome
Timeframe: Day 28Data are biomarker fasting concentrations
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Plasma Lipopolysaccharide-binding Protein
|
4035 ng/mL
Standard Error 339
|
4435 ng/mL
Standard Error 380
|
7890 ng/mL
Standard Error 1143
|
8572 ng/mL
Standard Error 1394
|
SECONDARY outcome
Timeframe: Day 28Lactulose/mannitol ratio in urine collected 0-5 h post-ingestion of non-digestible sugar probes.
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Urinary Lactulose/Mannitol Ratio
|
0.075 ratio
Standard Error 0.009
|
0.084 ratio
Standard Error 0.012
|
0.087 ratio
Standard Error 0.013
|
0.065 ratio
Standard Error 0.007
|
SECONDARY outcome
Timeframe: Day 28Sucralose/Erythritol ratio measured in urine collected 0-24 h post-ingestion of non-digestible sugar probes
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Urinary Sucralose/Erythritol Ratio
|
0.014 ratio
Standard Error 0.0014
|
0.014 ratio
Standard Error 0.0015
|
0.015 ratio
Standard Error 0.001
|
0.015 ratio
Standard Error 0.001
|
SECONDARY outcome
Timeframe: Day 28Data are biomarker concentrations at fasting
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Plasma Interleukin-6
|
1.9 pg/mL
Standard Error 0.085
|
1.9 pg/mL
Standard Error 0.070
|
3.1 pg/mL
Standard Error 0.24
|
3.3 pg/mL
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Day 25-27 (pooled samples) of the 28-day interventionData are biomarker fecal concentrations, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Fecal Calprotectin
|
35.9 ug/g
Standard Error 5.5
|
24.4 ug/g
Standard Error 2.7
|
42.5 ug/g
Standard Error 9.3
|
36.7 ug/g
Standard Error 5.2
|
SECONDARY outcome
Timeframe: Day 25-27 (pooled samples) of the 28-day interventionData are biomarker fecal concentrations, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Fecal Myeloperoxidase
|
97.4 ng/g
Standard Error 9.9
|
83.4 ng/g
Standard Error 7.5
|
148.1 ng/g
Standard Error 40.9
|
97.9 ng/g
Standard Error 10.5
|
SECONDARY outcome
Timeframe: Day 28Data are plasma concentrations of epigallocatechin gallate
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Plasma Epigallocatechin Gallate
|
0.001 umol/L
Standard Error 0.001
|
0.343 umol/L
Standard Error 0.057
|
0.00 umol/L
Standard Error 0.00
|
0.21 umol/L
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Day 28Data are plasma concentrations of epicatechin.
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Plasma Epicatechin
|
0.0 umol/L
Standard Error 0.0
|
0.022 umol/L
Standard Error 0.0048
|
0.00016 umol/L
Standard Error 0.00016
|
0.015 umol/L
Standard Error 0.003
|
SECONDARY outcome
Timeframe: Day 28Data are plasma concentrations of epicatechin gallate.
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Plasma Epicatechin Gallate
|
0.002 umol/L
Standard Error 0.001
|
0.30 umol/L
Standard Error 0.037
|
0.002 umol/L
Standard Error 0.001
|
0.20 umol/L
Standard Error 0.027
|
SECONDARY outcome
Timeframe: Day 28Data are biomarker concentrations at fasting
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Plasma 3,4-γ-valerolactone
|
0.008 umol/L
Standard Error 0.005
|
0.17 umol/L
Standard Error 0.050
|
0.007 umol/L
Standard Error 0.003
|
0.090 umol/L
Standard Error 0.031
|
SECONDARY outcome
Timeframe: Day 28Data are biomarker concentrations at fasting
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Plasma 3,4,5-γ-Valerolactone
|
0.001 umol/L
Standard Error 0.001
|
0.034 umol/L
Standard Error 0.017
|
0.0017 umol/L
Standard Error 0.0010
|
0.0060 umol/L
Standard Error 0.0047
|
SECONDARY outcome
Timeframe: Day 28Data are biomarker concentrations at fasting
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Plasma Soluble Cluster of Differentiation-14
|
1465 ng/mL
Standard Error 57
|
1459 ng/mL
Standard Error 71
|
1424 ng/mL
Standard Error 67
|
1367 ng/mL
Standard Error 83
|
SECONDARY outcome
Timeframe: Day 28Data are biomarker concentrations at fasting
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Plasma Glucose
|
86.3 mg/dL
Standard Error 1.6
|
83.9 mg/dL
Standard Error 1.5
|
98.9 mg/dL
Standard Error 3.0
|
98.6 mg/dL
Standard Error 2.6
|
SECONDARY outcome
Timeframe: Day 28Data are biomarker concentrations at fasting
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Plasma Insulin
|
6.4 μIU/mL
Standard Error 0.7
|
6.0 μIU/mL
Standard Error 0.6
|
19.6 μIU/mL
Standard Error 2.3
|
22.4 μIU/mL
Standard Error 3.8
|
SECONDARY outcome
Timeframe: Day 28Data are biomarker concentrations at fasting
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Plasma Triglyceride
|
51.2 mg/dL
Standard Error 4.1
|
54.7 mg/dL
Standard Error 4.9
|
140.5 mg/dL
Standard Error 14.0
|
149.9 mg/dL
Standard Error 17.0
|
SECONDARY outcome
Timeframe: Day 28Data are biomarker concentrations at fasting
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Plasma Total Cholesterol
|
195.5 mg/dL
Standard Error 9.4
|
186.9 mg/dL
Standard Error 6.7
|
220.1 mg/dL
Standard Error 9.0
|
215.6 mg/dL
Standard Error 10.2
|
SECONDARY outcome
Timeframe: Day 28Data are biomarker concentrations at fasting
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Serum Alanine Transaminase
|
15.0 (U/L)
Standard Error 0.9
|
15.0 (U/L)
Standard Error 1.0
|
24.2 (U/L)
Standard Error 2.1
|
23.6 (U/L)
Standard Error 2.3
|
SECONDARY outcome
Timeframe: Day 28Data are biomarker concentrations at fasting
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Serum Aspartate Transaminase
|
17.3 U/L
Standard Error 0.9
|
17.5 U/L
Standard Error 0.8
|
19.5 U/L
Standard Error 0.8
|
20.2 U/L
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Day 28Data are biomarker concentrations at fasting
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Blood Hematocrit
|
44.3 Percent
Standard Error 0.7
|
45.1 Percent
Standard Error 0.8
|
44.0 Percent
Standard Error 0.6
|
43.5 Percent
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Day 28Data are biomarker fasting concentrations
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Plasma Tumor Necrosis Factor-alpha
|
1.2 pg/mL
Standard Error 0.32
|
2.3 pg/mL
Standard Error 0.53
|
4.8 pg/mL
Standard Error 0.81
|
5.0 pg/mL
Standard Error 0.62
|
SECONDARY outcome
Timeframe: Days 25-27 (pooled samples) of the 28-day interventionData are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Fecal Butyrate
|
11.7 umol/g
Standard Error 1.8
|
10.8 umol/g
Standard Error 1.4
|
16.6 umol/g
Standard Error 2.4
|
13.9 umol/g
Standard Error 1.4
|
SECONDARY outcome
Timeframe: Days 25-27 (pooled samples) of the 28-day interventionData are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Fecal Acetate
|
35.9 umol/g
Standard Error 5.2
|
33.1 umol/g
Standard Error 3.4
|
47.9 umol/g
Standard Error 4.1
|
41.9 umol/g
Standard Error 3.5
|
SECONDARY outcome
Timeframe: Day 25-27 (pooled samples) from the 28-day interventionData are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Fecal Valeric Acid
|
0.95 umol/g
Standard Error 0.16
|
0.91 umol/g
Standard Error 0.13
|
2.04 umol/g
Standard Error 0.30
|
1.86 umol/g
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Day 25-27 (pooled samples) from the 28-day interventionData are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Fecal Hexanoic Acid
|
0.56 umol/g
Standard Error 0.16
|
0.49 umol/g
Standard Error 0.14
|
0.98 umol/g
Standard Error 0.59
|
0.55 umol/g
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Day 25-27 (pooled samples) from the 28-day interventionData are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Fecal Isobutyric Acid
|
1.86 umol/g
Standard Error 0.18
|
1.67 umol/g
Standard Error 0.22
|
1.87 umol/g
Standard Error 0.21
|
1.87 umol/g
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Day 25-27 (pooled samples) of the 28-day interventionData are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Fecal 2-Methylbutyric
|
1.29 umol/g
Standard Error 0.13
|
1.14 umol/g
Standard Error 0.16
|
1.20 umol/g
Standard Error 0.15
|
1.20 umol/g
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Day 25-27 (pooled samples) of the 28-day interventionData are biomarker concentrations in fecal samples, measured in samples pooled from specimens collected on Days 25-27 of the 28-day intervention.
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Fecal Isovaleric Acid
|
1.40 umol/g
Standard Error 0.14
|
1.22 umol/g
Standard Error 0.16
|
1.38 umol/g
Standard Error 0.16
|
1.40 umol/g
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Day 28Data are biomarker fasting concentrations
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Plasma Ascorbic Acid
|
40.2 umol/L
Standard Error 4.7
|
41.6 umol/L
Standard Error 4.3
|
32.1 umol/L
Standard Error 4.5
|
28.6 umol/L
Standard Error 3.6
|
SECONDARY outcome
Timeframe: Day 28Data are biomarker fasting concentrations
Outcome measures
| Measure |
Healthy - Placebo
n=19 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
Healthy - GTE
n=19 Participants
Confection with green tea extract consumed daily for 4 weeks.
|
MetS - Placebo
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
MetS - GTE
n=21 Participants
Confection without green tea extract consumed daily for 4 weeks.
|
|---|---|---|---|---|
|
Plasma Uric Acid
|
244.7 umol/L
Standard Error 13.8
|
256.0 umol/L
Standard Error 14.0
|
330.3 umol/L
Standard Error 13.9
|
319.8 umol/L
Standard Error 16.0
|
Adverse Events
Healthy Participants - GTE Confection Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Participants - Placebo Confection Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MetS Participants - GTE Confection Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MetS Participants - Placebo Confection Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place