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临床试验/NCT00392873
NCT00392873已完成不适用

"REFUEL" Active Women's Study II: Increased Caloric Intake to Reverse Energy Deficiency in Exercising Women: Impact on Bone and Menstrual Cyclicity

Penn State University2 个研究点 分布在 1 个国家目标入组 233 人开始时间: 2006年9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
233
试验地点
2
主要终点
Bone mineral density

研究概览

简要总结

The purpose of this study is to examine the effects of increased food intake on the menstrual cycle and bone health in physically active women who have irregular or absent menstrual cycles. This study will examine whether a 12 month period of increased food intake will cause menstrual cycles to resume and help bones get stronger.

详细描述

Low levels of estrogen found in physically active, premenopausal women with irregular or absent menstrual periods is likely caused by insufficient energy (calorie) intake compared to energy expenditure. Premenopausal women with menstrual disturbances and amenorrhea suffer from reductions in bone mineral density, particularly in the lumbar spine. Bone loss observed in amenorrheic women may be serious enough to result in osteoporotic fractures, but is also associated with a high prevalence of stress fractures. Increased calorie intake should help improve energy status, menstrual status, and bone health.

Comparison: Premenopausal women with irregular or absent menstrual periods will be assigned to either receive additional calories or serve as controls. A group of premenopausal women with normal menstrual periods will also be used for comparison.

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
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Bone mineral density

时间窗: 1 year

Reproductive hormones

时间窗: 1 year

Metabolic bone markers

时间窗: 1 year

Metabolic hormones

时间窗: 1 year

次要结局

  • Eating Disorder Inventory-2 (EDI-2)(1 year)
  • Three Factor Eating Questionnaire(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Jane DeSouza

Professor of Kinesiology and Physiology

Penn State University

研究点 (2)

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