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临床试验/NCT01119976
NCT01119976已完成不适用

Evaluation of the Association Between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
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

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

结局指标

主要结局

Body weight

时间窗: 3 months

次要结局

  • Waist Circumference(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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