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Brain Energy and Cognition

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ClinicalTrials.gov Identifier: NCT01603550
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : October 6, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
This proposed laboratory study will extend previous findings on relationships between cognitive function and nutritional status to conditions that more closely resemble military operations where aerobic exercise, inadequate nutritional intake and sleep deprivation combine to degrade cognitive function. The investigators will examine cognitive function, brain activity and glucose levels in volunteers who are calorie-deprived, performing high workload cognitive tests, exercising and, in one arm of the study, are sleep-deprived for approximately 48 hours. A comprehensive cognitive test battery will be repeatedly administered and several cognitive tests will be administered when volunteers are exercising. Interstitial glucose levels will be assessed and whole body nitrogen utilization determined. The effects of energy restriction and the physiological basis of the relationship between peripheral glucose levels and cognitive function will be examined using a state-of-the-art imaging technology, functional Magnetic Resonance Imaging (fMRI). This technique will allow any key brain regions affected by caloric deprivation to be identified.

Condition or disease Intervention/treatment
Energy Restriction Sleep Deprivation Other: Sleep Deprivation Other: Energy Restriction

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Brain Energy and Cognition
Study Start Date : June 2012
Primary Completion Date : June 2015
Study Completion Date : June 2015
Arms and Interventions

Arm Intervention/treatment
Experimental: Energy Restriction Other: Energy Restriction
Energy Restriction
Experimental: Sleep Deprivation Other: Sleep Deprivation
Sleep Deprivation

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Fluent in English (non-native English speakers can be enrolled); males and females aged 18 - 39 years.

Exclusion Criteria:

  • Not yet reached 18th birthday, metal implants - which can interfere with fMRI scanning; fear of small places; pregnant (USARIEM will test for pregnancy), Attention Deficit Hyperactivity Disorder (ADHD) - if previously documented by a waiver; acute or chronic physical limitation that would hinder performing cycle exercise; known allergies to medical adhesives.
Contacts and Locations

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): NCT01603550

United States, Massachusetts
Natick, Massachusetts, United States, 01760
Sponsors and Collaborators
United States Army Research Institute of Environmental Medicine
United States Army Natick Soldier Research Development and Engineering Center
Massachusetts Institute of Technology
Principal Investigator: Harris R. Lieberman, PhD US Army Research Institute of Environmental Medicine
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Harris R. Lieberman, Research Psychologist, United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier: NCT01603550     History of Changes
Other Study ID Numbers: H10-09
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Harris R. Lieberman, United States Army Research Institute of Environmental Medicine:
energy restriction
sleep deprivation
cognitive performance
brain function

Additional relevant MeSH terms:
Sleep Deprivation
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders