Evaluation of the Association Between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
This is a research study to look at the association between weight loss and the menstrual cycle in healthy, overweight, premenopausal women. Participants will be asked to follow a reduced-calorie diet and exercise plan for 3 months.
详细描述
Two different reduced calorie diet and exercise plans will be compared. One plan changes diet and exercise prescription with the phases of the menstrual cycle, while the other is a standard reduced calorie diet and exercise plan based on MyPyramid.gov website.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy females between the ages of 18-40 (inclusive)
- •BMI between 26.5-35.4 kg/m² (inclusive)
- •Regular menstrual cycle (28 ± 3 days)
- •Weight stable (within ± 3-kg) 2 months prior to study inclusion
- •Must use barrier contraception (e.g. male/female condom) for the study's duration
- •Must be willing to follow the prescribed diet/exercise plan for the study's duration
排除标准
- •On hormonal contraceptives or any other daily use of medications which can make the subject unsuitable for inclusion in the study.
- •Any significant health problem (history of cancer, HIV/AIDS, Diabetes, cardiovascular disease, untreated hypothyroidism, etc.)
- •Restrictions against participating in cardiovascular exercise and strength training
- •Any condition, which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
- •Women who are pregnant, lactating, or planning to become pregnant during the study period
研究组 & 干预措施
Group A
Reduced calorie diet and exercise plan that changes with phases of the menstrual cycle
干预措施: Reduced calorie diet and exercise plan (Behavioral)
Group B
Different reduced calorie diet and exercise plan based on MyPyramid.gov website
干预措施: Different reduced calorie diet and exercise plan (Behavioral)
结局指标
主要结局
Body weight
时间窗: 3 months
次要结局
- Waist Circumference(3 months)