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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):

May 18, 2012
May 23, 2012
October 6, 2016
June 2012
June 2015   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01603550 on ClinicalTrials.gov Archive Site
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Brain Energy and Cognition
Brain Energy and Cognition
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.
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
  • Energy Restriction
  • Sleep Deprivation
  • Other: Sleep Deprivation
    Sleep Deprivation
  • Other: Energy Restriction
    Energy Restriction
  • Experimental: Energy Restriction
    Intervention: Other: Energy Restriction
  • Experimental: Sleep Deprivation
    Intervention: Other: Sleep Deprivation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2015
June 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 39 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Plan to Share IPD: Undecided
Harris R. Lieberman, United States Army Research Institute of Environmental Medicine
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
United States Army Research Institute of Environmental Medicine
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP