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Trial record 69 of 750 for:    Area Under Curve AND meal

Sleep Timing and Energy Balance

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ClinicalTrials.gov Identifier: NCT01866280
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

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.


Condition or disease Intervention/treatment Phase
Sleep Meals Behavioral: Normal sleep Behavioral: Normal meals Behavioral: Late sleep Behavioral: Late meals Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Sleep Timing, Independent of Duration, on Food Intake and Metabolic Control of Energy Balance
Study Start Date : November 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: Normal sleep Normal meals
Normal sleep/Normal meal times
Behavioral: Normal sleep
Normal sleep= sleep 2300-0700

Behavioral: 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

Experimental: Normal sleep Late meals
Normal sleep/Late meal times
Behavioral: Normal sleep
Normal sleep= sleep 2300-0700

Behavioral: 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.

Experimental: Late sleep Late meals
Late sleep/Late meal times
Behavioral: Late sleep
Late sleep=sleep at 0230-1030 hours

Behavioral: 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.

Experimental: Late sleep Normal meals
Late sleep/Normal meal times
Behavioral: 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

Behavioral: Late sleep
Late sleep=sleep at 0230-1030 hours




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866280


Locations
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United States, New York
St. Luke's/Roosevelt Hospital
New York, New York, United States, 10025
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center

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Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01866280     History of Changes
Other Study ID Numbers: ST-01
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015
Keywords provided by St. Luke's-Roosevelt Hospital Center:
Sleep
Sleep duration
Meals
Food intake
Obesity