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临床试验/NCT01866280
NCT01866280已完成不适用

Effect of Sleep Timing, Independent of Duration, on Food Intake and Metabolic Control of Energy Balance

St. Luke's-Roosevelt Hospital Center1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年11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
5
试验地点
1
主要终点
Oral Glucose Tolerance

研究概览

简要总结

The purpose of this study is to test the effects of sleep and meal timing, independent of sleep duration, on glucose regulation and metabolic and hormonal control of energy balance in normal weight adults.

This study will be a 4-phase, randomized controlled study of 5 days each in which participants will undergo 2 phases of late sleep times that differ in meal timing (normal or late) and 2 phases of normal sleep times that differ in meal timing (normal or late).

The Aims and Hypotheses of this study are:

Aim 1: To compare hormonal regulation of food intake and metabolic risk markers in response to altered sleep and meal timing.

  • Hypothesis 1: There will be an interaction between sleep and meal time on glucose, insulin, and glucose and insulin area under the curve after the glucose tolerance test such that the late sleep/late meal will result in the worst metabolic profile, normal sleep/late meal and late sleep/normal meal will have an intermediate profile, and normal sleep/normal meal will result in the best metabolic profile.
  • Hypothesis 2: There will be an interaction between sleep and meal time on leptin and ghrelin concentrations such that the late sleep/late meal timing phase will result in low leptin/high ghrelin, normal sleep/late meal timing and late sleep/normal meal will have an intermediate profile, and normal sleep/normal meal timing will result in high leptin/low ghrelin.

Aim 2: To compare food intake over a 24-h period in response to altered sleep and meal timing.

• Hypothesis 3: Energy and fat intakes will be greater during the late sleep timing phase compared to normal sleep timing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index 22-25
  • Normal scores on sleep questionnaires (PSQI, ESS, Berlin, SDIQ)
  • Normal score on Beck Depression Inventory
  • Intermediate chronotype on Composite Scale of Morningness/Eveningness

排除标准

  • Neurological, medical, or psychiatric disorders
  • Eating disorders
  • Sleep disorders
  • Travel across time zones
  • History of drug/alcohol abuse
  • Caffeine intake >300 mg/d
  • Excessive daytime sleepiness
  • Pregnancy or within 1 y post-partum

结局指标

主要结局

Oral Glucose Tolerance

时间窗: 2 hours

Oral glucose tolerance test will be performed at scheduled breakfast time on day 4

Food intake

时间窗: Single day

Ad libitum food intake will be assessed on day 5

Meal tolerance test

时间窗: 3 hours

Glucose and insulin responses to a liquid meal will be assessed at scheduled lunch time

次要结局

  • Hormonal profile(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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