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Sleep Timing and Energy Balance

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01866280
Enrollment
5
Registered
2013-05-31
Start date
2012-11-30
Completion date
2013-09-30
Last updated
2015-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep, Meals

Keywords

Sleep, Sleep duration, Meals, Food intake, Obesity

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.

Interventions

BEHAVIORALNormal sleep

Normal sleep= sleep 2300-0700

BEHAVIORALNormal 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

BEHAVIORALLate sleep

Late sleep=sleep at 0230-1030 hours

BEHAVIORALLate 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.

Sponsors

St. Luke's-Roosevelt Hospital Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Food intakeSingle dayAd libitum food intake will be assessed on day 5
Oral Glucose Tolerance2 hoursOral glucose tolerance test will be performed at scheduled breakfast time on day 4
Meal tolerance test3 hoursGlucose and insulin responses to a liquid meal will be assessed at scheduled lunch time

Secondary

MeasureTime frameDescription
Hormonal profile24 hoursOn day 3, the following hormones will be assessed from overnight hours: glucose, insulin, cortisol, melatonin, leptin, ghrelin, PYY, GLP-1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026