EXERCISE, DIET, AND SEX HORMONES IN POSTMENOPAUSAL WOMEN

描述（由申请人提供）：在一项随机试验中，173名年龄在50-75岁的绝经后妇女，我们发现，一个设施为基础的中等强度（45分钟/天，5天/周）有氧运动干预显着降低血清雌酮和游离雌二醇在3个月内，也就是说，减少两个绝经后乳腺癌风险的生物标志物。我们建议进行另一项随机试验，以测试联合低热量饮食加有氧运动干预是否可以延长血清雌激素的减少，并超过单独运动干预或单独低热量饮食干预所达到的减少程度。该研究将在一项4臂随机对照试验中对503名绝经后妇女进行两种生活方式干预的效果进行测试和比较：1）中等强度有氧运动干预（N=135）; 2）低热量饮食干预（N=135）; 3）运动和低热量饮食联合干预（N=135）; 4）对照组（无干预）（N=98）。主要终点为血清雌酮。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线照片密度、肥胖（体重、BMI、腰和臀;周长、全身脂肪和DXA脂肪%）和生活质量。如果妇女是绝经后、年龄50-75岁、健康、超重或肥胖（BMI > 25.0 kg/m2）、久坐不动（中度活动少于30分钟/周）、不使用HRT X 6个月，不吸烟者。减少热量的干预措施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45分钟/天，5天/周，中等强度的有氧运动（例如步行），结合设施和家庭运动与行为训练。参加者将通过大量邮寄和媒体安排的方式招募，并将接受若干筛选活动。将对参与者进行12个月的随访，并对基线、中期和干预结束时的措施进行评估和比较。将通过运动和饮食日志以及每周称重监测干预依从性。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.