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Clinical Trials/NCT02960776
NCT02960776CompletedNot Applicable

Effect of Long Term Sleep Restriction on Energy Balance

Columbia University1 site in 1 country45 target enrollmentStarted: November 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
45
Locations
1
Primary Endpoint
Endpoint Fat Volume

Study Overview

Brief Summary

The overall goal of this project is to look at the effects of long-term, sustained sleep restriction (SR) in adults, and assess the effects on mood and cognitive and physical performance.

Detailed Description

Chronic Sleep Restriction (SR) is highly prevalent in today's modern society. Artificial light, portable electronic devices, and 24-h services have allowed individuals to remain active throughout the night, leading to reductions in sleep duration. SSD has been linked to obesity and our laboratory has been interested in establishing whether sleep could be a causal factor in the etiology of obesity. Given the increasing prevalence of obesity over the past 5 decades, coinciding with the marked reduction in sleep duration, further exploration into the role of sleep as a risk factor for obesity could provide additional ammunition in the fight to prevent further increases in the incidence of obesity.

This study will be a randomized, crossover, outpatient SR study with 2 phases of 6 weeks each, with a 6 week wash-out period between the phases. Sleep duration in each phase will be the participant's regular bed- and wake times during the habitual sleep (HS) phase and HS minus 1.5 hours in the SR phase. During the HS phase, participants will be asked to follow a fixed bedtime routine based on their screening sleep schedule. During the SR phase, participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
20 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •BMI 25-29.9 kg/m2
  • •Have at least one obese parent
  • •Habitually sleep 7-9 hours a night
  • •Free of any current and past sleep and psychiatric disorders, including eating disorders, diabetes or Cardiovascular disease (CVD) (i.e., normal scores on: Pittsburgh Quality of Sleep Questionnaire Epworth Sleepiness Scale, Berlin Questionnaire, Sleep Disorders Inventory Questionnaire, Beck Depression Inventory, Composite Scale of Morningness/Eveningness, Three Factor Eating Questionnaire)
  • •All racial/ethnic groups

Exclusion Criteria

  • •Smokers (any cigarettes or ex-smoker < 3 years)
  • •Neurological, medical or psychiatric disorder
  • •Diabetics
  • •Eating and/or sleep disorders
  • •Contraindications for MRI scanning
  • •Travel across time zones within 4 weeks
  • •History of drug and alcohol abuse
  • •Shift worker (or rotating shift worker)
  • •Caffeine intake > 300 mg/d
  • •Heavy equipment operators
  • •Commercial long-distance drivers

Arms & Interventions

Habitual Sleep (HS)

No Intervention

Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.

Sleep Restriction (SR)

Experimental

Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase.

Intervention: Sleep Restriction (SR) (Behavioral)

Outcomes

Primary Outcomes

Endpoint Fat Volume

Time Frame: Week 6 (endpoint)

Body composition (specifically fat volume) will be measured by MRI at baseline and endpoint.

Secondary Outcomes

  • Energy Expenditure (EE)(Measured over 14 days at the end of each phase (weeks 5 and 6; endpoint))
  • Physical Activity(Average over 6 weeks (measured daily))
  • Ghrelin(6 weeks)
  • Regional Brain Activation in Response to Food Stimuli(Week 6)
  • Sedentary Behavior(Average over 6 weeks (measured daily))
  • Leptin(6 weeks)
  • Glucagon-like Peptide 1(6 weeks)
  • Orexin(6 weeks)
  • Neuropeptide Y(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marie-Pierre St-Onge

Associate Professor of Nutritional Medicine

Columbia University

Study Sites (1)

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