Effects of Four-day Fast on Gut-derived Hormones and Inflammatory Markers in Healthy, Normal-weight Women.
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
- Hormone levels change from baseline.
研究概览
简要总结
The original study executed between 2002-2004 was an interventional trial in which 20, healthy, normal-weight female subjects were randomized to a four-day fast plus daily subcutaneous injections of leptin or a four day fast plus daily subcutaneous injections of a placebo. The primary endpoints were gonadotropin pulsatility, TSH secretion and thyroid function, and cortisol secretion. The current study is a secondary analysis focussed on the placebo group which underwent a four-day fast. The study is looking at the effects of fasting on gut-derived hormones and inflammatory markers in healthy, normal-weight women. The hypothesis for this secondary analysis was that four days of fasting would augment levels of orexigenic gut-derived hormones and suppress levels of anorexigenic gut-derived horomones, while suppressing secretion of inflammatory cytokines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
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
- •female age 18-35
- •BMI 20-26.0
- •eumenorrheic with normal FSH, TSH, Prolactin
- •Hgb > 12 g/dL, normal creatinine
- •normal puberty and development
- •negative pregnancy test. In addition, subjects agreed not to be sexually active during the course of the inpatient study and to use contraception for a period of 48 hours after discharge from the hospital.
排除标准
- •medical or endocrine problems known to affect thyroid, reproductive, GH or cortisol function
- •medications known to affect neuroendocrine function
- •prior history of eating disorder or significant menstrual irregularities
- •subjects who have a known hypersensitivity to E. Coli derived protein.
- •subjects with a history of seizure disorder, significant cardiac disease, medication for cardiac disease, or kidney disease
- •history of anaphylaxis or anaphylactoid like reactions.
研究组 & 干预措施
Fasting alone
干预措施: Fasting (Behavioral)
Fasting plus leptin
干预措施: Leptin administration (Drug)
Fasting plus leptin
干预措施: Fasting (Behavioral)
结局指标
主要结局
Hormone levels change from baseline.
时间窗: Change from baseline after 4 days of intervention.
Original study looking at gonadotropin pulsitility, TSH secretion and thyroid function, and cortisol secretion. Present study looking at gut-hormone secretion.
次要结局
- Levels of inflammatory cytokines change from baseline.(Change from baseline after 4 days of intervention.)