Brain Energy and Cognition

This study is currently recruiting participants.
Verified September 2013 by United States Army Research Institute of Environmental Medicine
Sponsor:
Collaborators:
United States Army Natick Soldier Research Development and Engineering Center
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Harris R. Lieberman, United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier:
NCT01603550
First received: May 18, 2012
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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 Intervention
Energy Restriction
Sleep Deprivation
Other: Sleep Deprivation
Other: Energy Restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Brain Energy and Cognition

Further study details as provided by United States Army Research Institute of Environmental Medicine:

Estimated Enrollment: 52
Study Start Date: June 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Energy Restriction Other: Energy Restriction
Energy Restriction
Experimental: Sleep Deprivation Other: Sleep Deprivation
Sleep Deprivation

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • MUST BE ACTIVE DUTY ARMY STATIONED AT NATICK SOLDIER SYSTEMS CENTER
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603550

Contacts
Contact: Tracey J Smith, PhD 508-233-4868 tracey.j.smith@us.army.mil

Locations
United States, Massachusetts
USARIEM Recruiting
Natick, Massachusetts, United States, 01760
Contact: Smith       tracey.j.smith@us.army.mil   
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
  More Information

No publications provided

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
Study First Received: May 18, 2012
Last Updated: September 9, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on April 16, 2014