Resveratrol in Postmenopausal Women With High Body Mass Index
Ключови думи
Резюме
Описание
PRIMARY OBJECTIVES:
I. To determine the effect of pharmacological doses of resveratrol on serum estradiol levels in post-menopausal women with high body mass index (BMI).
SECONDARY OBJECTIVES:
I. Assess the effect of resveratrol on serum estrone, testosterone, and sex hormone-binding globulin (SHBP).
II. Assess the effect of resveratrol on serum levels of insulin and C-peptide. III. Assess the effect of resveratrol on adipocytokine expression and secretion as measured by serum leptin and adiponectin.
IV. Assess the effect of resveratrol on inflammatory cytokines as measured by serum C-reactive protein (CRP).
V. Assess the effect of resveratrol on oxidative stress as measured by urinary 8-isoprostaglandin F2 alpha (8-iso-PGF2 alpha) and 8-hydroxydeoxyguanosine (8OHdG).
VI. Assess the safety of resveratrol intervention as measured by reported adverse events, complete blood count with differential (CBC/diff), comprehensive metabolic panel (CMP), and lipid profile.
VII. Assess the relationship between systemic study agent exposure and biomarker modulation.
OUTLINE:
Patients receive resveratrol orally (PO) once daily (QD) for 12 weeks.
After completion of study therapy, patients are followed up for 2 weeks
Дати
| Последна проверка: | 03/31/2014 |
| Първо изпратено: | 06/08/2011 |
| Очаквано записване подадено: | 06/08/2011 |
| Първо публикувано: | 06/09/2011 |
| Изпратена последна актуализация: | 10/07/2014 |
| Последна актуализация публикувана: | 10/08/2014 |
| Действителна начална дата на проучването: | 05/31/2011 |
| Приблизителна дата на първично завършване: | 06/30/2012 |
| Очаквана дата на завършване на проучването: | 06/30/2012 |
Състояние или заболяване
Интервенция / лечение
Drug: Basic Science (resveratrol)
Other: Basic Science (resveratrol)
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Basic Science (resveratrol) Patients receive resveratrol PO QD for 12 weeks. | Drug: Basic Science (resveratrol) Given PO |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 35 Years Да се 35 Years |
| Полове, допустими за проучване | Female |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Healthy postmenopausal women with a body mass index (BMI) of 25 kg/m^2 or greater - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; Karnofsky 70% or above - Leukocytes >= 3,000/uL - Absolute neutrophil count (ANC) >= 1,500/uL - Platelets >= 100,000/uL - Total bilirubin =< 2.0 mg/dL - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 1.5 times upper limit of normal (ULN) - Creatinine =< 1.0 times ULN - Ability and willingness to limit resveratrol-containing foods to no more than one serving each per day for about 14 weeks - Negative mammogram or negative workup of mammographic findings within prior 12 months prior to enrollment for women >= 50 years of age - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Have had invasive cancer(s) within the past 5 years except non-melanoma skin cancer - Within 3 months of or concurrent usage of any other investigational agents - History of allergic reactions attributed to resveratrol - Unwilling or unable to refrain from taking herbal medicines and dietary supplements - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Within 3 months of or concurrent estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone-releasing hormone analogs, prolactin inhibitors, or antiandrogens; vaginal estrogen is acceptable. Within 3 months of or concurrent usage of tamoxifen, raloxifene, other selective estrogen-receptor modulators, or aromatase inhibitors - Regular usage (more than 2 times a week) of estrogenic supplements or herbal remedies (e.g., Remifemin, black cohosh, red clover, dong quai, soy isoflavones, dehydroepiandrosterone [DHEA], flaxseed, diindolylmethane [DIM], genistein, and daidzein) within the past 3 months or concurrently; dietary consumption of phytoestrogens/isoflavones (such as soy, tofu, millet, barley, natto, tempeh, miso, soy milk, soy sauce) is acceptable as these sources are not concentrated - Concurrent use of anti-diabetic drugs such as: - Insulin - Sulfonylureas (e.g., glipizide, glyburide, or glimepiride) - Meglitinides (e.g., repaglinide or nateglinide) - Biguanides (e.g., metformin) - Thiazolidinediones (e.g., rosiglitazone or pioglitazone) - Alpha-glucosidase inhibitors (e.g., acarbose or miglitol) - Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin) - Concurrent use of warfarin or phenytoin |
Резултат
Първични изходни мерки
1. Change in serum estradiol levels in postmenopausal women with high BMI [From baseline to 12 weeks (post-intervention)]
Вторични изходни мерки
1. Change in serum estrone [From baseline to 12 weeks (post-intervention)]
2. Change in serum testosterone [From baseline to 12 weeks (post-intervention)]
3. Change in serum sex hormone-binding globulin (SHBG) [From baseline to 12 weeks (post-intervention)]
4. Change in serum levels of insulin [From baseline to 12 weeks (post-intervention)]
5. Change in serum levels of C-peptide [From baseline to 12 weeks (post-intervention)]
6. Change in serum leptin [From baseline to 12 weeks (post-intervention)]
7. Change in serum adiponectin [From baseline to 12 weeks (post-intervention)]
8. Change in inflammatory markers, measured by serum C-reactive protein [From baseline to 12 weeks (post-intervention)]
9. Change in urinary 8-iso-PGF2alpha [From baseline to 12 weeks (post-intervention)]
10. Change in urinary 8OHdG [From baseline to 12 weeks (post-intervention)]
11. Incidence of reported adverse events [Up to 12 weeks]
12. Incidence of changes in CBC/diff, blood chemistry, and lipids [Up to 12 weeks]
13. Study agent/metabolite levels [Up to 12 weeks]
