Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2012-11-30
2013-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Normal sleep Normal meals
Normal sleep/Normal meal times
Normal sleep
Normal sleep= sleep 2300-0700
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
Normal sleep Late meals
Normal sleep/Late meal times
Normal sleep
Normal sleep= sleep 2300-0700
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.
Late sleep Late meals
Late sleep/Late meal times
Late sleep
Late sleep=sleep at 0230-1030 hours
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.
Late sleep Normal meals
Late sleep/Normal meal times
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
Late sleep
Late sleep=sleep at 0230-1030 hours
Interventions
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Normal sleep
Normal sleep= sleep 2300-0700
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
Late sleep
Late sleep=sleep at 0230-1030 hours
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
45 Years
ALL
Yes
Sponsors
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St. Luke's-Roosevelt Hospital Center
OTHER
Responsible Party
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Locations
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St. Luke's/Roosevelt Hospital
New York, New York, United States
Countries
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Other Identifiers
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ST-01
Identifier Type: -
Identifier Source: org_study_id
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