Sleep Timing and Energy Balance

NCT01866280 | Completed DMC

• 1 other identifier: ST-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Meals

Keywords

Sleep; Sleep duration; Meals; Food intake; Obesity

Outcome Measures

Primary Outcomes (3)

• Food intake

  Ad libitum food intake will be assessed on day 5

  Single day

• Oral Glucose Tolerance

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

  2 hours

• Meal tolerance test

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

  3 hours

Secondary Outcomes (1)

• Hormonal profile

  24 hours

Study Arms (4)

Normal sleep Normal meals

EXPERIMENTAL

Normal sleep/Normal meal times

Behavioral: Normal sleep; Behavioral: Normal meals

Normal sleep Late meals

EXPERIMENTAL

Normal sleep/Late meal times

Behavioral: Normal sleep; Behavioral: Late meals

Late sleep Late meals

EXPERIMENTAL

Late sleep/Late meal times

Behavioral: Late sleep; Behavioral: Late meals

Late sleep Normal meals

EXPERIMENTAL

Late sleep/Normal meal times

Behavioral: Normal meals; Behavioral: Late sleep

Interventions

Normal sleep BEHAVIORAL

Normal sleep= sleep 2300-0700

Normal sleep Late meals; Normal sleep Normal meals

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 Normal meals; Normal sleep Normal meals

Late sleep BEHAVIORAL

Late sleep=sleep at 0230-1030 hours

Late sleep Late meals; Late sleep Normal meals

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.

Late sleep Late meals; Normal sleep Late meals

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead

Study Sites (1)

St. Luke's/Roosevelt Hospital

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: May 31, 2013
• Study Start: November 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

US (1)