Clinical trial NCT01603550: Brain Energy and Cognition
Official title: Brain Energy and Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Restriction
Sleep Deprivation
Keywords: energy restriction
sleep deprivation
cognitive performance
brain function
Lead sponsor: United States Army Research Institute of Environmental Medicine
Sponsor class: FED
Collaborators: name: United States Army Natick Soldier Research Development and Engineering Center
name: Massachusetts Institute of Technology
First posted: 2012-05-23
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Natick
country: United States
facility: USARIEM
state: Massachusetts
Study officials:
affiliation: US Army Research Institute of Environmental Medicine
name: Harris R. Lieberman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lieberman HR, Bukhari AS, Caldwell JA, Wilson MA, Mahoney CR, Pasiakos SM, McClung JP, Smith TJ. Two Days of Calorie Deprivation Induced by Underfeeding and Aerobic Exercise Degrades Mood and Lowers Interstitial Glucose but Does Not Impair Cognitive Function in Young Adults. J Nutr. 2017 Jan;147(1):110-116. doi: 10.3945/jn.116.238246. Epub 2016 Nov 2.
citation: Karl JP, Smith TJ, Wilson MA, Bukhari AS, Pasiakos SM, McClung HL, McClung JP, Lieberman HR. Altered metabolic homeostasis is associated with appetite regulation during and following 48-h of severe energy deprivation in adults. Metabolism. 2016 Apr;65(4):416-27. doi: 10.1016/j.metabol.2015.11.001. Epub 2015 Nov 6.
citation: O'Connor KL, Scisco JL, Smith TJ, Young AJ, Montain SJ, Price LL, Lieberman HR, Karl JP. Altered Appetite-Mediating Hormone Concentrations Precede Compensatory Overeating After Severe, Short-Term Energy Deprivation in Healthy Adults. J Nutr. 2016 Feb;146(2):209-17. doi: 10.3945/jn.115.217976. Epub 2016 Jan 6.