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Clinical Trials/NCT01866280
NCT01866280CompletedNot Applicable

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

St. Luke's-Roosevelt Hospital Center1 site in 1 country5 target enrollmentStarted: November 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
5
Locations
1
Primary Endpoint
Oral Glucose Tolerance

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
20 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Oral Glucose Tolerance

Time Frame: 2 hours

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

Food intake

Time Frame: Single day

Ad libitum food intake will be assessed on day 5

Meal tolerance test

Time Frame: 3 hours

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

Secondary Outcomes

  • Hormonal profile(24 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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