Sleep Timing and Energy Balance

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep, Meals

Intervention / Treatment
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* Behavioral: Normal sleep
* Behavioral: Normal meals
* Behavioral: Late sleep
* Behavioral: Late meals


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Sleep duration, Meals, Food intake, Obesity