Green Tea and Reduction of Breast Cancer Risk
January 25, 2016 updated by: University of Minnesota
Phase II, Randomized,Double-blind, Placebo-controlled, Study of the Efficacy of Green Tea Extract on Biomarkers of Breast Cancer Risk in High Risk Women With Differing Catechol-O-methyl Transferase (COMT) Genotypes
RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer.
PURPOSE: This phase II trial is studying how well green tea extract works in preventing breast cancer compared to a placebo in postmenopausal women with high breast density.
The investigators have hypothesized that green tea consumption reduces breast cancer risk, and this effect is seen primarily in women who have the low-activity COMT genotype. The investigators will test this by evaluating the effects of green tea extract on breast cancer biomarkers including mammographic density, plasma insulin-like growth factor 1 (IGF-1), IGF binding protein 3 (IGFBP-3), estrone, estradiol, androstenedione, sex hormone binding globulin (SHBG), urinary estrogen metabolites and plasma F2-isoprostanes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary:
1.1 To determine the effects of green tea extract consumption (containing 800 mg EGCG per day) for 12 months on the following recognized biomarkers of breast cancer risk:
- Mammographic density
- Circulating concentrations of insulin-like growth factor 1 (IGF-1) and IGF binding protein 3 (IGFBP-3)
- Circulating concentrations of reproductive hormones (estrone, estradiol, androstenedione) and sex hormone binding globulin (SHBG)
1.2 To determine the effects of COMT genotype on the green tea extract effects described above.
- Secondary:
2.1 To determine the effects of green tea extract consumption (containing 800 mg EGCG per day) for 12 months on the following hypothesized biomarkers of breast cancer risk:
- Urinary estrogen metabolites (estrone, estradiol, and their 2-hydroxy, 4-hydroxy, 2-methoxy, and 4-methoxy metabolites, estriol, and 16- hydroxyestrone)
- Circulating concentrations of F-2 isoprostanes, a recognized biomarker of systemic oxidative stress
2.2 To determine the effects of COMT genotype on the green tea extract effects described above.
2.3 To determine the effects of COMT genotype on catechin metabolism and excretion, as measured by circulating and urinary concentrations.
Study Type
Interventional
Enrollment (Actual)
1075
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Edina, Minnesota, United States, 55435
- Fairview Southdale Breast Center
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Maple Grove, Minnesota, United States, 55369
- Fairview Maple Grove Breast Center
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Medical Center (UMMC) Breast Clinic
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St. Louis Park, Minnesota, United States, 55426
- Park Nicollet Institute
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St. Paul, Minnesota, United States, 55108
- Food Science and Nutrition, University of Minnesota
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
46 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Signed informed consent
- Healthy postmenopausal women aged 50-70 years
- "Heterogeneously dense" (51-75% glandular) or "extremely dense" (>75%glandular) breasts
- Willing to avoid consumption of green tea for 1 year
Exclusion Criteria:
- Positive serological markers of hepatitis B or hepatitis C infections
- Elevated levels of liver enzymes
- Recent (within 6 mo) or current hormone or hormone modification therapy, including systemic hormone replacement therapy, SERMS and aromatase inhibitors
- Current smoker of cigarettes or other tobacco products
- BMI <19 or >40 kg/m2
- Weight change > 10 lbs during the previous year
- History of breast cancer or proliferative breast disease
- Regular consumption of > 7 alcoholic drinks/wk
- Regular consumption of green tea (>1 cup/wk)
- Recent (within 6 mo) or current use of chemopreventive agents such as tamoxifen, raloxifene or aromatase inhibitors
- Participation in any weight loss or weight gain studies
- Currently taking Methotrexate or Enbrel
- History of ovarian cancer
- Any form of cancer in the last 5 years
- Presence of implants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Green tea extract
Green tea extract capsules containing 80.7 % total catechins (51.7 % EGCG)
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Two green tea extract capsules twice daily after breakfast and dinner for one year
Other Names:
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Placebo Comparator: Sugar pill
Placebo capsules containing 50% maltodextrin, 49.5 % cellulose, and 0.5 % magnesium stearate
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Two placebo capsules twice daily after breakfast and dinner for one year
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mammographic Density
Time Frame: Baseline and month 12
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Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.
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Baseline and month 12
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Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)
Time Frame: Baseline and month 12
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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.
|
Baseline and month 12
|
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Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3
Time Frame: Baseline and month 12
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Circulating levels of IGF-1 and IGFBP-3 were measured in fasting blood samples by ELISA method.
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Baseline and month 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mindy S Kurzer, Ph.D, University of Minnesota
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Samavat H, Wu AH, Ursin G, Torkelson CJ, Wang R, Yu MC, Yee D, Kurzer MS, Yuan JM. Green Tea Catechin Extract Supplementation Does Not Influence Circulating Sex Hormones and Insulin-Like Growth Factor Axis Proteins in a Randomized Controlled Trial of Postmenopausal Women at High Risk of Breast Cancer. J Nutr. 2019 Apr 1;149(4):619-627. doi: 10.1093/jn/nxy316.
- Arikawa AY, Samavat H, Gross M, Kurzer MS. Plasma F2-isoprostanes Are Positively Associated with Glycemic Load, but Inversely Associated with Dietary Polyunsaturated Fatty Acids and Insoluble Fiber in Postmenopausal Women. J Nutr. 2017 Sep;147(9):1693-1699. doi: 10.3945/jn.117.254631. Epub 2017 Jul 26.
- Samavat H, Newman AR, Wang R, Yuan JM, Wu AH, Kurzer MS. Effects of green tea catechin extract on serum lipids in postmenopausal women: a randomized, placebo-controlled clinical trial. Am J Clin Nutr. 2016 Dec;104(6):1671-1682. doi: 10.3945/ajcn.116.137075. Epub 2016 Nov 2.
- Dostal AM, Arikawa A, Espejo L, Kurzer MS. Long-Term Supplementation of Green Tea Extract Does Not Modify Adiposity or Bone Mineral Density in a Randomized Trial of Overweight and Obese Postmenopausal Women. J Nutr. 2016 Feb;146(2):256-64. doi: 10.3945/jn.115.219238. Epub 2015 Dec 23.
- Dostal AM, Samavat H, Espejo L, Arikawa AY, Stendell-Hollis NR, Kurzer MS. Green Tea Extract and Catechol-O-Methyltransferase Genotype Modify Fasting Serum Insulin and Plasma Adiponectin Concentrations in a Randomized Controlled Trial of Overweight and Obese Postmenopausal Women. J Nutr. 2016 Jan;146(1):38-45. doi: 10.3945/jn.115.222414. Epub 2015 Nov 18.
Helpful Links
- The Minnesota Green Tea Trial (MGTT), a randomized controlled trial of the efficacy of green tea extract on biomarkers of breast cancer risk: study rationale, design, methods, and participant characteristics
- The safety of green tea extract supplementation in postmenopausal women at risk for breast cancer: results of the Minnesota Green Tea Trial
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
June 8, 2009
First Submitted That Met QC Criteria
June 9, 2009
First Posted (Estimate)
June 10, 2009
Study Record Updates
Last Update Posted (Estimate)
February 22, 2016
Last Update Submitted That Met QC Criteria
January 25, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0806M36121
- R01CA127236 (U.S. NIH Grant/Contract)
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