Pilot Study of Resveratrol in Postmenopausal Women With High Body Mass Index
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change in serum estradiol levels in postmenopausal women with high BMI
研究概览
简要总结
This pilot phase I trial studies resveratrol in postmenopausal women with high body mass index. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of resveratrol may keep cancer from forming. Studying samples of blood and urine in the laboratory from postmenopausal women who are taking resveratrol may help doctors learn more about the effects of resveratrol on biomarkers.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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:
- •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
研究组 & 干预措施
Basic Science (resveratrol)
Patients receive resveratrol PO QD for 12 weeks.
干预措施: resveratrol (Drug)
Basic Science (resveratrol)
Patients receive resveratrol PO QD for 12 weeks.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Change in serum estradiol levels in postmenopausal women with high BMI
时间窗: From baseline to 12 weeks (post-intervention)
A two-sided paired t-test will be performed to determine whether the change is significant at a significance level of 5%. If the data distribution indicates non-normality or skewedness in violation of the assumptions of the t-test, non-parametric tests will be used. Linear regression techniques will be used to adjust for potential confounders, e.g. age and BMI.
次要结局
- Change in serum estrone(From baseline to 12 weeks (post-intervention))
- Change in serum sex hormone-binding globulin (SHBG)(From baseline to 12 weeks (post-intervention))
- Change in inflammatory markers, measured by serum C-reactive protein(From baseline to 12 weeks (post-intervention))
- Change in urinary 8-iso-PGF2alpha(From baseline to 12 weeks (post-intervention))
- Change in serum testosterone(From baseline to 12 weeks (post-intervention))
- Change in serum leptin(From baseline to 12 weeks (post-intervention))
- Change in urinary 8OHdG(From baseline to 12 weeks (post-intervention))
- Study agent/metabolite levels(Up to 12 weeks)
- Change in serum levels of insulin(From baseline to 12 weeks (post-intervention))
- Change in serum levels of C-peptide(From baseline to 12 weeks (post-intervention))
- Change in serum adiponectin(From baseline to 12 weeks (post-intervention))
- Incidence of reported adverse events(Up to 12 weeks)
- Incidence of changes in CBC/diff, blood chemistry, and lipids(Up to 12 weeks)