Trial Outcomes & Findings for Green Tea and Reduction of Breast Cancer Risk (NCT NCT00917735)
NCT ID: NCT00917735
Last Updated: 2016-02-22
Results Overview
Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1075 participants
Primary outcome timeframe
Baseline and month 12
Results posted on
2016-02-22
Participant Flow
August 2009 through April 2013
Prior to randomization, participants went through a screening clinic visit in which anthropometric characteristics and blood pressure were measured. In addition, blood was drawn to assess catechol-O-methyltransferase (COMT) genotype, hepatic function, and serological markers of hepatitis B and C virus.
Participant milestones
| Measure |
Green Tea Extract
Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of epigallocatechin gallate (EGCG).
|
Sugar Pill
Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
|
|---|---|---|
|
Overall Study
STARTED
|
538
|
537
|
|
Overall Study
COMPLETED
|
463
|
474
|
|
Overall Study
NOT COMPLETED
|
75
|
63
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Green Tea and Reduction of Breast Cancer Risk
Baseline characteristics by cohort
| Measure |
Green Tea Extract
n=538 Participants
Green tea extract supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year
|
Sugar Pill
n=537 Participants
Placebo: Two placebo capsules twice daily after breakfast and dinner for one year
|
Total
n=1075 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 5.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
538 Participants
n=5 Participants
|
537 Participants
n=7 Participants
|
1075 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
516 Participants
n=5 Participants
|
510 Participants
n=7 Participants
|
1026 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
515 Participants
n=5 Participants
|
505 Participants
n=7 Participants
|
1020 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
538 participants
n=5 Participants
|
537 participants
n=7 Participants
|
1075 participants
n=5 Participants
|
|
Height
|
163.5 cm
STANDARD_DEVIATION 6.3 • n=5 Participants
|
164.3 cm
STANDARD_DEVIATION 6.2 • n=7 Participants
|
163.9 cm
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Weight
|
67.4 kg
STANDARD_DEVIATION 10.6 • n=5 Participants
|
67.9 kg
STANDARD_DEVIATION 10.5 • n=7 Participants
|
67.4 kg
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Waist-to-hip ratio
|
0.84 Ratio
STANDARD_DEVIATION 0.1 • n=5 Participants
|
0.83 Ratio
STANDARD_DEVIATION 0.1 • n=7 Participants
|
0.83 Ratio
STANDARD_DEVIATION 0.07 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and month 12Population: Mammographic density at baseline and month 12
Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.
Outcome measures
| Measure |
Green Tea Extract
n=462 Participants
Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
|
Sugar Pill
n=470 Participants
Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
|
|---|---|---|
|
Mammographic Density
Percent mammographic density at baseline
|
22.71 Percent
Interval 21.39 to 24.1
|
21.84 Percent
Interval 20.59 to 23.17
|
|
Mammographic Density
Percent mammographic density at month 12
|
22.09 Percent
Interval 20.77 to 23.5
|
21.13 Percent
Interval 19.88 to 22.47
|
PRIMARY outcome
Timeframe: Baseline and month 12Population: Circulating concentrations of reproductive hormones including estrone, estradiol, androstenedione, testosterone, sex hormone binding globulin (SHBG) at baseline and month 12
Circulating levels of reproductive hormones including estrone, estradiol, androstenedione, testosterone and SHBG were measured in fasting blood samples by liquid chromatography/tandem mass spectrometry method.
Outcome measures
| Measure |
Green Tea Extract
n=463 Participants
Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
|
Sugar Pill
n=474 Participants
Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
|
|---|---|---|
|
Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)
Circulating estrone at baseline
|
22.8 pg/ml
Interval 21.6 to 24.0
|
23.6 pg/ml
Interval 22.4 to 24.9
|
|
Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)
Circulating estrone at month 12
|
22.5 pg/ml
Interval 21.3 to 23.7
|
22.4 pg/ml
Interval 21.3 to 23.6
|
|
Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)
Circulating estradiol at baseline
|
3.4 pg/ml
Interval 3.1 to 3.8
|
3.7 pg/ml
Interval 3.3 to 4.1
|
|
Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)
Circulating estradiol at month 12
|
3.7 pg/ml
Interval 3.4 to 4.1
|
3.1 pg/ml
Interval 2.8 to 3.5
|
|
Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)
Circulating androstenedione at baseline
|
479.8 pg/ml
Interval 459.4 to 501.2
|
507.2 pg/ml
Interval 485.9 to 529.5
|
|
Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)
Circulating androstenedione at month 12
|
468.8 pg/ml
Interval 450.2 to 488.3
|
479.5 pg/ml
Interval 460.6 to 499.1
|
|
Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)
Circulating testosterone at baseline
|
151.0 pg/ml
Interval 142.7 to 159.7
|
161.6 pg/ml
Interval 152.8 to 170.8
|
|
Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)
Circulating testosterone at month 12
|
158.1 pg/ml
Interval 149.9 to 166.9
|
155.1 pg/ml
Interval 147.1 to 163.6
|
|
Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)
Circulating SHBG at baseline
|
68.1 pg/ml
Interval 65.0 to 71.3
|
69.1 pg/ml
Interval 66.0 to 72.3
|
|
Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)
Circulating SHBG at month 12
|
68.7 pg/ml
Interval 65.5 to 72.0
|
68.7 pg/ml
Interval 65.5 to 72.0
|
PRIMARY outcome
Timeframe: Baseline and month 12Population: Circulating concentrations of IGF axis proteins including insulin-like growth factor (IGF-1) and IGF binding protein 3 (IGFBP-3) at baseline and month 12
Circulating levels of IGF-1 and IGFBP-3 were measured in fasting blood samples by ELISA method.
Outcome measures
| Measure |
Green Tea Extract
n=462 Participants
Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
|
Sugar Pill
n=473 Participants
Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
|
|---|---|---|
|
Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3
Circulating IGF-1 at baseline
|
87.5 ng/ml
Interval 85.3 to 89.8
|
88.3 ng/ml
Interval 86.1 to 90.5
|
|
Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3
Circulating IGF-1 at month 12
|
83.7 ng/ml
Interval 81.6 to 85.8
|
83.1 ng/ml
Interval 81.0 to 85.2
|
|
Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3
Circulating IGFBP-3 at baseline
|
2048.0 ng/ml
Interval 2008.9 to 2088.0
|
2047.6 ng/ml
Interval 2008.9 to 2087.1
|
|
Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3
Circulating IGFBP-3 at month 12
|
2048.1 ng/ml
Interval 2008.0 to 2089.1
|
2040.7 ng/ml
Interval 2001.0 to 2081.0
|
Adverse Events
Green Tea Extract
Serious events: 12 serious events
Other events: 407 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 8 serious events
Other events: 391 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Green Tea Extract
n=538 participants at risk
Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
|
Sugar Pill
n=537 participants at risk
Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
|
|---|---|---|
|
Hepatobiliary disorders
Elevated ALT or AST enzyme
|
1.3%
7/538 • Number of events 9 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
0.00%
0/537 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Social circumstances
Motorcycle accident
|
0.00%
0/538 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
0.19%
1/537 • Number of events 1 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Blood and lymphatic system disorders
Hypertension
|
0.00%
0/538 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
0.19%
1/537 • Number of events 1 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/538 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
0.19%
1/537 • Number of events 1 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Social circumstances
Fall
|
0.00%
0/538 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
0.19%
1/537 • Number of events 1 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Surgical and medical procedures
Surgery
|
0.56%
3/538 • Number of events 3 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
0.37%
2/537 • Number of events 2 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Ear and labyrinth disorders
Acoustic Neuroma
|
0.19%
1/538 • Number of events 1 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
0.00%
0/537 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diagnosis of Uterine Cancer
|
0.00%
0/538 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
0.37%
2/537 • Number of events 2 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Gastrointestinal disorders
Colitis
|
0.19%
1/538 • Number of events 1 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
0.00%
0/537 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
Other adverse events
| Measure |
Green Tea Extract
n=538 participants at risk
Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
|
Sugar Pill
n=537 participants at risk
Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
43.7%
235/538 • Number of events 235 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
34.3%
184/537 • Number of events 184 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Infections and infestations
Infections
|
40.1%
216/538 • Number of events 216 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
40.4%
217/537 • Number of events 217 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Vascular disorders
Vascular
|
28.6%
154/538 • Number of events 154 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
26.8%
144/537 • Number of events 144 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Respiratory, thoracic and mediastinal disorders
Respitory
|
22.7%
122/538 • Number of events 122 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
22.7%
122/537 • Number of events 122 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
General disorders
General
|
12.8%
69/538 • Number of events 69 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
14.3%
77/537 • Number of events 77 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
Musculoskeletal and connective tissue disorders
Musuclar
|
12.1%
65/538 • Number of events 65 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
12.8%
69/537 • Number of events 69 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
|
General disorders
Other
|
52.0%
280/538 • Number of events 280 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
40.6%
218/537 • Number of events 218 • 5 years
Adverse event information was coded and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place