Implications for the Timing of Energy Availability on Menstrual Cycle Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Urinary estrone-3-glucuronide (E3G)
研究概览
简要总结
The primary aim of this clinical trial is to evaluate how fasted prolonged exercise may influence circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length when energy availability is maintained at or above 30 kcal/kg lean body mass/ day among women who regularly do running or cycling exercise. A secondary aim is to determine the effects of fasted prolonged exercise on serum leptin and cortisol.
Participants will be asked to do the following over a ~3 month enrollment period:
- attend a laboratory visit at the beginning of the study to have their resting metabolic rate, aerobic fitness, and body composition tested
- monitor their menstrual cycle length, urine hormones, perceived stress levels, and diet for ~3 months
- complete 3, 90-minute exercise sessions on a stationary bike or treadmill either fed (consuming a carbohydrate meal 1 h prior and 0.7 g carbohydrate/ kg body mass/ h during exercise) or fasted (consuming no meal prior and no carbohydrates during exercise) during month ~3
- saliva samples will be taken prior to and after 90-minute exercise sessions for quantification of leptin and cortisol
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •participates in structured running or cycling exercise for at least 30 minutes on 3 or more days per week
- •accustomed to exercising for 90 minutes or more
- •has regular periods every 21-35 days
- •have not taken hormonal contraceptives for at least the past 6 months
- •is not currently or trying to become pregnant or breastfeeding, and has not been pregnant or breastfeeding in the past 12 months
- •does not currently have a diagnosis of a major menstrual cycle disorder (i.e., amenorrhea, polycystic ovary syndrome [PCOS], endometriosis, ovarian cancer, ovarian insufficiency, uterine or endometrial cancer)
- •does not currently have a metabolic disease (i.e., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes, congenital adrenal hyperplasia)
- •does not currently have a major cardiovascular or respiratory disease
排除标准
- •miss more than 7 consecutive days of aerobic activity (i.e., running, cycling, cross training)
- •demonstrate clinical low energy availability as defined as energy availability <30 kcal/kg fat free mass
- •report menstrual cycle lengths <21 or >35 days in the first 2 months of at-home monitoring
- •do not demonstrate an anticipated rise in luteinizing hormone and progesterone in the first 2 months of at-home monitoring
- •begin taking a hormonal contraceptive
- •become pregnant
- •are diagnosed with a menstrual cycle disorder (i.e., amenorrhea, polycystic ovary syndrome [PCOS], endometriosis, ovarian cancer, ovarian insufficiency, uterine, or endometrial cancer)
- •are diagnosed with a metabolic disease (i.e., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes)
- •are diagnosed with a major cardiovascular or respiratory disease
- •are unable to follow instructions for any of the procedures
研究组 & 干预措施
Fed with Carbohydrates
Participants will complete 3, 90-minute stationary cycle or treadmill exercise sessions 1 h after consuming a meal containing 1 g carbohydrate/ kg body weight. During exercise, they will consume an artificially sweetened beverage containing 0.7 g carbohydrate/ kg body mass/ h as a 2:1 mixture of glucose and fructose.
干预措施: Artificially Sweetened Carbohydrate Beverage (Dietary Supplement)
Fasted without Carbohydrates
Participants will complete 3, 90-minute stationary cycle or treadmill exercise sessions following an overnight fast. During exercise, they will consume an artificially sweetened beverage containing no carbohydrates.
干预措施: Artificially Sweetened Beverage (Dietary Supplement)
结局指标
主要结局
Urinary estrone-3-glucuronide (E3G)
时间窗: 3 months
ng/mL
Urinary pregnanediol glucuronide (PdG)
时间窗: 3 months
ug/mL
Menstrual cycle length
时间窗: 3 months
days
Urinary luteinizing hormone (LH)
时间窗: 3 months
MIU/mL
次要结局
- Salivary leptin(3 days)
- Salivary cortisol(3 days)
研究者
Marissa Baranauskas
Assistant Professor
University of Colorado, Colorado Springs