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Completed

NCT Number: NCT01866280

Sleep Timing and Energy Balance

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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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Luke's/Roosevelt Hospital

New York, 10025, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal sleep

Behavioral

Normal sleep= sleep 2300-0700

Normal meals

Behavioral

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

Behavioral

Late sleep=sleep at 0230-1030 hours

Late meals

Behavioral

Late meal times= approximately 4.5, 7, and 13 h after wake up time for breakfast, lunch and dinner, and snack at 15 h.

Primary outcomes

  1. Food intake

    Time frame: Single day

    Ad libitum food intake will be assessed on day 5

  2. Oral Glucose Tolerance

    Time frame: 2 hours

    Oral glucose tolerance test will be performed at scheduled breakfast time on day 4

  3. Meal tolerance test

    Time frame: 3 hours

    Glucose and insulin responses to a liquid meal will be assessed at scheduled lunch time

Secondary outcomes

  1. Hormonal profile

    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

Sponsors and collaborators

Lead sponsor

St. Luke's-Roosevelt Hospital Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 31, 2013
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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