EXERCISE, DIET, AND SEX HORMONES IN POSTMENOPAUSAL WOMEN

描述(申请人提供)：在一项对173名年龄在50-75岁的绝经后妇女进行的随机试验中，我们发现基于设施的中等强度(45分钟/天，5天/周)的有氧运动干预在3个月内显著降低了血清雌酮和游离雌二醇，也就是说，降低了两个已建立的绝经后乳腺癌风险的生物标记物。在这里，我们建议进行另一项随机试验，以测试低卡路里饮食和有氧运动干预相结合是否可以将血清雌激素的降低延长到超过单独运动干预或单独减少卡路里饮食干预所达到的降低程度。这项拟议的研究将对503名绝经后妇女进行为期一年的随机对照试验，测试和比较两种生活方式干预的效果：1)中等强度有氧运动干预(N=135)；2)低卡路里饮食干预(N=135)；3)运动和低卡路里饮食联合干预(N=135)；以及4)对照组(不干预)(N=98)。主要终点将是血清雌酮。次要终点将包括血清雌二醇、游离雌二醇、睾酮、游离睾酮、性激素结合蛋白、胰岛素样生长因子(IFG)-I、IGF结合蛋白-3、胰岛素、乳房X光照片密度、肥胖度(体重、BMI、腰围和臀围；周长、全身脂肪和来自DXA的脂肪百分比)和生活质量。如果女性是绝经后，年龄50-75岁，健康，超重或肥胖(BMI和GT；25.0公斤/平方米)，久坐(中等活动每周少于30分钟)，不使用HRT X 6个月，以及不吸烟，则符合条件。卡路里减少干预将使用糖尿病预防计划生活方式行为改变计划的修改，目标是每天1200-1800千卡，体重减少7%。运动干预将是每天45分钟，每周5天，中等强度的有氧运动(如步行)，设施和家庭运动与行为训练相结合。参与者将通过群发邮件和媒体安置招募，并将接受几项筛选活动。参与者将被跟踪12个月，并对基线、中期和干预结束措施进行评估和比较。干预依从性将通过锻炼和饮食记录以及每周称重进行监测。将测量潜在的不良反应，包括损伤、总体骨密度(DEXA)和生活质量。

DESCRIPTION (provided by applicant): In a randomized trial of 173 postmenopausal women aged 50-75 years, we found that a facility-based moderate-intensity (45 min/day, 5 d/wk) aerobic exercise intervention significantly decreased serum estrone and free estradiol in 3 months, that is, a decrease in two established biomarkers of postmenopausal breast cancer risk. We propose here to conduct another randomized trial to test whether a combined reduced-calorie diet plus aerobic exercise intervention could extend the reduction of serum estrogens over and beyond the degree of reduction achieved by either an exercise-alone intervention or a reduced-calorie diet alone intervention. The proposed study will test and compare the effects over one year of two lifestyle interventions in 503 postmenopausal women in a 4-arm randomized controlled trial: 1) a moderate-intensity aerobic exercise intervention (N=135); 2) a reduced-calorie diet intervention (N=135); 3) the combined exercise and reduced calorie diet interventions (N=135); and 4) control (no intervention) (N=98). The primary endpoint will be serum estrone. Secondary endpoints will include serum estradiol, free estradiol, testosterone, free testosterone, sex hormone binding protein, insulin-like growth factor IFG)-I, IGF binding protein-3, insulin, mammogram density, adiposity (weight, BMI, waist and hip; circumferences, total body fat and % fat from DXA), and Quality of Life. Women will be eligible if they are postmenopausal, aged 50-75 years, healthy, overweight or obese (BMI > 25.0 kg/m2), sedentary (less than 30 min/week in moderate activity), not using HRT X 6 mos., and nonsmokers. The calorie reduction intervention will use a modification of the Diabetes Prevention Program lifestyle behavior change program, with goals of 1200-1800 kcal/day and 7% reduction in body weight. The exercise intervention will be 45 min/day, 5 days/week, moderate-intensity aerobic (e.g. walking), combined facility and home exercise with behavioral training. Participants will be recruited through mass mailings and media placements and will undergo several screening activities. Participants will be followed for 12 months and baseline, interim, and end-of-intervention measures will be assessed and compared. Intervention adherence will be monitored via exercise and diet logs and weekly weighing. Potential adverse effects will be measured including injuries, overall bone density (DEXA), and Quality of Life.