NCT01580761

Brief Summary

Insufficient sleep may be one of the most common, and most preventable, obesity risk factors. The investigators wish to determine whether 14 nights of modest sleep restriction results in increased energy balance, thus potentially increasing the risk of obesity. The investigators hypothesize that sleep restriction will result in increased energy balance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

5.8 years

First QC Date

April 17, 2012

Last Update Submit

January 18, 2022

Conditions

Obesity

Outcome Measures

Primary Outcomes (4)

  • Change in caloric intake and hunger

    Change in caloric intake and hunger, measured during acclimation, experimental and recovery timepoints.

    baseline to 21 days

  • Change in energy expenditure

    Change in energy expenditure, including activity energy expenditure, thermic effect of food (TEF), and basal metabolic rate (BMR), measured during acclimation, experimental and recovery timepoints..

    baseline to 21 days

  • Change in fat tissue characteristics and body composition

    Changes in fat tissue characteristics from serial fat biopsies, and in body composition from DEXA and CT imaging, measured during acclimation, experimental and recovery timepoints.

    baseline to 21 days

  • Change in metabolic hormones

    Change in metabolic hormones measured during acclimation, experimental and recovery timepoints.

    baseline to 21 days

Secondary Outcomes (6)

  • Change in neurocognitive deficits

    baseline to 21 days

  • Change in blood pressure and autonomic function

    baseline to 21 days

  • Change in markers of inflammation and endothelial function

    baseline to 21 days

  • Change in electrocardiographic characteristics

    baseline to 21 days

  • Change in arterial stiffness

    baseline to 21 days

  • +1 more secondary outcomes

Study Arms (2)

Sleep restriction

EXPERIMENTAL

Sleep restriction

Behavioral: Sleep restriction

Normal sleep

NO INTERVENTION

Normal sleep

Interventions

Sleep restrictionBEHAVIORAL

14 days of sleep restriction, 4 hours of sleep per day.

Sleep restriction

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40 years
  • BMI of 18.5-30 kg/m2
  • Not a current smoker or tobacco user
  • No chronic medical or psychiatric disorders
  • On no prescription medications other than second generation antihistamines (cetirizine, fexofenadine, desloratadine, loratadine, etc), oral contraceptive pills, or intrauterine devices
  • History of normal sleep patterns, defined as nocturnal sleep duration of 6.5-8 hours per night without regular daytime naps

You may not qualify if:

  • The investigators will exclude subjects who have any medical or psychiatric disorders
  • History of anxiety or depression
  • Those taking any medications other than non-sedating antihistamines or oral contraceptives will be excluded
  • Those found to have depression on a depression screening tool (BDI-II) will be excluded
  • Current smokers will be excluded
  • All female subjects will undergoing a screening pregnancy test and excluded if positive
  • Subjects found to have significant sleep disorders will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Covassin N, Singh P, McCrady-Spitzer SK, St Louis EK, Calvin AD, Levine JA, Somers VK. Effects of Experimental Sleep Restriction on Energy Intake, Energy Expenditure, and Visceral Obesity. J Am Coll Cardiol. 2022 Apr 5;79(13):1254-1265. doi: 10.1016/j.jacc.2022.01.038.

    PMID: 35361348DERIVED

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Virend Somers, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 17, 2012

First Posted

April 19, 2012

Study Start

July 1, 2012

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

January 21, 2022

Record last verified: 2022-01

Locations

US(1)