NCT01603550

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

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

May 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

May 18, 2012

Last Update Submit

October 5, 2016

Conditions

Energy RestrictionSleep Deprivation

Keywords

energy restrictionsleep deprivationcognitive performancebrain function

Study Arms (2)

Energy Restriction

EXPERIMENTAL
Other: Energy Restriction

Sleep Deprivation

EXPERIMENTAL
Other: Sleep Deprivation

Interventions

Sleep DeprivationOTHER

Sleep Deprivation

Sleep Deprivation
Energy RestrictionOTHER

Energy Restriction

Energy Restriction

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USARIEM

Natick, Massachusetts, 01760, United States

Location

Related Publications (3)

  • 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.

    PMID: 27807037DERIVED

  • 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.

    PMID: 26975533DERIVED

  • 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.

    PMID: 26740683DERIVED

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Harris R. Lieberman, PhD

    US Army Research Institute of Environmental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Psychologist

Study Record Dates

First Submitted

May 18, 2012

First Posted

May 23, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 6, 2016

Record last verified: 2016-10

Locations

US(1)