Green Tea and Reduction of Breast Cancer Risk
Raktažodžiai
Santrauka
apibūdinimas
OBJECTIVES:
1. 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:
1. Mammographic density
2. Circulating concentrations of insulin-like growth factor 1 (IGF-1) and IGF binding protein 3 (IGFBP-3)
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.
2. 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:
1. Urinary estrogen metabolites (estrone, estradiol, and their 2-hydroxy, 4-hydroxy, 2-methoxy, and 4-methoxy metabolites, estriol, and 16- hydroxyestrone)
2. 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.
Datos
| Paskutinį kartą patikrinta: | 12/31/2015 |
| Pirmasis pateikimas: | 06/07/2009 |
| Numatytas registravimas pateiktas: | 06/08/2009 |
| Pirmas paskelbtas: | 06/09/2009 |
| Paskutinis atnaujinimas pateiktas: | 01/24/2016 |
| Paskutinis atnaujinimas paskelbtas: | 02/21/2016 |
| Pirmųjų rezultatų pateikimo data: | 07/28/2015 |
| Pirmojo QC rezultatų pateikimo data: | 01/24/2016 |
| Pirmųjų paskelbtų rezultatų data: | 02/21/2016 |
| Faktinė studijų pradžios data: | 06/30/2009 |
| Numatoma pirminio užbaigimo data: | 05/31/2014 |
| Numatoma studijų užbaigimo data: | 05/31/2014 |
Būklė ar liga
Intervencija / gydymas
Drug: Green tea extract
Other: Sugar pill
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: Green tea extract Green tea extract capsules containing 80.7 % total catechins (51.7 % EGCG) | Drug: Green tea extract Two green tea extract capsules twice daily after breakfast and dinner for one year |
| Placebo Comparator: Sugar pill Placebo capsules containing 50% maltodextrin, 49.5 % cellulose, and 0.5 % magnesium stearate | Other: Sugar pill Two placebo capsules twice daily after breakfast and dinner for one year |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 50 Years Į 50 Years |
| Tinkamos studijoms lytys | Female |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
1. Mammographic Density [Baseline and month 12]
2. Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG) [Baseline and month 12]
3. Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3 [Baseline and month 12]
