St. Luke's/Roosevelt Hospital
New York, 10025, United States
NCT Number: NCT01866280
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.
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Notify Me20 year–45 year
All sexes
Interventional
Not applicable
New York, 10025, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Normal sleep= sleep 2300-0700
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=sleep at 0230-1030 hours
Late meal times= approximately 4.5, 7, and 13 h after wake up time for breakfast, lunch and dinner, and snack at 15 h.
Time frame: Single day
Ad libitum food intake will be assessed on day 5
Time frame: 2 hours
Oral glucose tolerance test will be performed at scheduled breakfast time on day 4
Time frame: 3 hours
Glucose and insulin responses to a liquid meal will be assessed at scheduled lunch time
Time frame: 24 hours
On day 3, the following hormones will be assessed from overnight hours: glucose, insulin, cortisol, melatonin, leptin, ghrelin, PYY, GLP-1
St. Luke's-Roosevelt Hospital Center
Other
Effect of Sleep Timing, Independent of Duration, on Food Intake and Metabolic Control of Energy Balance
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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