Sleep Timing and Energy Balance

Not Applicable

Completed

• Conditions: Meals; Sleep
• Interventions: Behavioral: Normal sleep; Behavioral: Late meals; Behavioral: Late sleep; Behavioral: Normal meals

• Registration Number: NCT01866280
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-05-28
• Study First Posted: 2013-05-31
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-17
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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Exclusion Criteria

• Neurological, medical, or psychiatric disorders
• Eating disorders
• Diabetes
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Normal sleep Normal meals	Normal sleep	Normal sleep/Normal meal times
Normal sleep Late meals	Normal sleep	Normal sleep/Late meal times
Late sleep Late meals	Late meals	Late sleep/Late meal times
Normal sleep Late meals	Late meals	Normal sleep/Late meal times
Late sleep Normal meals	Late sleep	Late sleep/Normal meal times
Normal sleep Normal meals	Normal meals	Normal sleep/Normal meal times
Late sleep Late meals	Late sleep	Late sleep/Late meal times
Late sleep Normal meals	Normal meals	Late sleep/Normal meal times

Primary Outcome Measures

Name	Time	Method
Oral Glucose Tolerance	2 hours	Oral glucose tolerance test will be performed at scheduled breakfast time on day 4
Food intake	Single day	Ad libitum food intake will be assessed on day 5
Meal tolerance test	3 hours	Glucose and insulin responses to a liquid meal will be assessed at scheduled lunch time

Secondary Outcome Measures

Name	Time	Method
Hormonal profile	24 hours	On day 3, the following hormones will be assessed from overnight hours: glucose, insulin, cortisol, melatonin, leptin, ghrelin, PYY, GLP-1

Trial Locations

Locations (1)

St. Luke's/Roosevelt Hospital; 🇺🇸 New York, New York, United States