Sleep Timing and Energy Balance

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

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 Overview

• Status: Completed
• Conditions: Sleep; Meals
• Intervention / Treatment: Behavioral: Normal sleep; Behavioral: Normal meals; Behavioral: Late meals; Behavioral: Late sleep

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10025
      • St. Luke's/Roosevelt Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal sleep Normal meals; Normal sleep/Normal meal times	Behavioral: Normal sleep; Normal sleep= sleep 2300-0700; Behavioral: Normal meals; Normal meal times=approximately 1.5, 5, and 11 h after wake up for breakfast, lunch, and dinner, and snack at 13 h after wake up time
Experimental: Normal sleep Late meals; Normal sleep/Late meal times	Behavioral: Normal sleep; Normal sleep= sleep 2300-0700; Behavioral: Late meals; Late meal times= approximately 4.5, 7, and 13 h after wake up time for breakfast, lunch and dinner, and snack at 15 h.
Experimental: Late sleep Late meals; Late sleep/Late meal times	Behavioral: Late meals; Late meal times= approximately 4.5, 7, and 13 h after wake up time for breakfast, lunch and dinner, and snack at 15 h.; Behavioral: Late sleep; Late sleep=sleep at 0230-1030 hours
Experimental: Late sleep Normal meals; Late sleep/Normal meal times	Behavioral: Normal meals; Normal meal times=approximately 1.5, 5, and 11 h after wake up for breakfast, lunch, and dinner, and snack at 13 h after wake up time; Behavioral: Late sleep; Late sleep=sleep at 0230-1030 hours

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: St. Luke's-Roosevelt Hospital Center

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: April 24, 2013
• First Submitted That Met QC Criteria: May 28, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Estimate): April 21, 2015
• Last Update Submitted That Met QC Criteria: April 17, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Obesity; Sleep; Sleep duration; Food intake; Meals
• Other Study ID Numbers: ST-01