A Randomized Cross-over Study of Low Energy Availability on Pituitary Function in Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change from baseline in stimulated pituitary function, as measured by Luteinizing hormone (LH) area under the curve (AUC) over two hours following pituitary stimulation with a physiologic bolus intravenous dose of gonadorelin acetate
研究概览
简要总结
The purpose of this study is to learn more about reproductive hormones and if they change in response to 5-days eating an individualized, standardized diet at two levels: energy balance and low energy intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-30
- •Body mass index between 18.5-24.9 OR 30-45
- •Have regular menstrual cycles between 18-40 days over the past 6 months
- •Weight stable (not gained or lost 5kg) in the past 3 months
排除标准
- •Using hormonal birth control currently or within the past three months
- •Polycystic ovary syndrome (current or past diagnosis)
- •Pregnant, lactating, planning to become pregnant in next 6 months
- •Engaging in regular intentional aerobic exercise
- •Significant medical issues (e.g.,cardiovascular disease or diabetes)
研究组 & 干预措施
Energy balanced metabolic diet (5-days)
45 kcals/kg of fat free mass [FFM]/day; 28% fat, 15% protein, 57% carbohydrate
干预措施: 5-day controlled metabolic dietary intake (Behavioral)
Low energy availability metabolic diet (5-days)
20 kcal/kg of FFM/day; 28% fat, 15% protein, 57% carbohydrate
干预措施: 5-day controlled metabolic dietary intake (Behavioral)
结局指标
主要结局
Change from baseline in stimulated pituitary function, as measured by Luteinizing hormone (LH) area under the curve (AUC) over two hours following pituitary stimulation with a physiologic bolus intravenous dose of gonadorelin acetate
时间窗: Baseline, ~4-weeks, ~8-weeks (visits timed to to days 1-5 of the menstrual cycle)
Within-participant changes in response to both conditions will be measured, with lower LH AUC indicating a blunted pituitary response to stimulation.
次要结局
未报告次要终点