"REFUEL" Active Women's Study II: Increased Caloric Intake to Reverse Energy Deficiency in Exercising Women: Impact on Bone and Menstrual Cyclicity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- Reproductive hormones
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
- 是
入选标准
- •for Ovulatory Control Volunteers:
- •18-35 years
- •BMI 16-25 kg/m2
- •At least 2 hr/wk of aerobic exercise
- •Gynecological age >/= 5 years
- •Weight stable (+/- 2 kg) last 6 months
- •History of regular menses for 6 months
- •Inclusion Criteria for Women with Irregular or Absent Menses:
- •18-35 years
- •BMI 16-25 kg/m2
- •At least 3 hr/wk of aerobic exercise
- •Gynecological age >/= 5 years
- •Weight stable (+/- 2 kg) last 6 months
- •No menses within past 3 months or 6 or less menses in last 12 months
- •Low to normal bone mass (L1-L4 Z score </=0)
排除标准
- •for all participants:
- •Hormonal contraceptives in last 6 months
- •Smoking currently
- •Current clinical diagnosis of an eating disorder
- •Use of medications incompatible with measurement of reproductive or metabolic hormones, including thyroid medications that may interfere with any of the study outcomes.
- •Dietary habits incompatible with prescribed diet for study
- •Any metabolic, reproductive or bone disease
- •Sedentary individuals with less than 120 minutes (2 hrs) of activity per week
研究组 & 干预措施
EAMD+Calories
This group contains women with exercise-associated menstrual disturbances (EAMD) and receives an intervention of increased caloric intake during the 12-month intervention. The targeted increase in caloric intake is 20-30% of baseline energy expenditure.
干预措施: EAMD+Calories (Behavioral)
EAMD Control
This group contains women with exercise-associated menstrual disturbances (EAMD) and undergoes the same procedures as the EAMD+Calories group. However, this group is instructed to maintain exercise and eating habits.
Heathy Control
This group contains exercising women with regular, ovulatory menstrual cycles. this group is instructed to maintain body weight and exercise and eating habits.
结局指标
主要结局
Reproductive hormones
时间窗: 1 year
Metabolic bone markers
时间窗: 1 year
Bone mineral density
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
Mary Jane DeSouza
Professor of Kinesiology and Physiology
Penn State University