Sleep Timing and Energy Balance

Sponsor

St. Luke's-Roosevelt Hospital Center (Other)

Overall Status

Completed

CT.gov ID

NCT01866280

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Meals	Behavioral: Normal sleep Behavioral: Normal meals Behavioral: Late sleep Behavioral: Late meals	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

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 sleep Late sleep=sleep at 0230-1030 hours 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 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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Luke's/Roosevelt Hospital	New York	New York	United States	10025

Sponsors and Collaborators

St. Luke's-Roosevelt Hospital Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

St. Luke's-Roosevelt Hospital Center

ClinicalTrials.gov Identifier:

NCT01866280

Other Study ID Numbers:

ST-01

First Posted:

May 31, 2013

Last Update Posted:

Apr 21, 2015

Last Verified:

Apr 1, 2015

Keywords provided by St. Luke's-Roosevelt Hospital Center

Study Results

No Results Posted as of Apr 21, 2015