Energy RestrictionNCT01603550
Brain Energy and Cognition
A study testing Sleep Deprivation and Energy Restriction in people with Energy Restriction and Sleep Deprivation, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Restriction, Sleep Deprivation
- What is being tested?
- Sleep Deprivation and Energy Restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Energy Restriction, Sleep Deprivation
- Being tested
- Sleep Deprivation, Energy Restriction
- Keywords
- energy restriction, sleep deprivation, cognitive performance, brain function
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep DeprivationOther
Sleep Deprivation
Energy RestrictionOther
Energy Restriction
| Study group | Role | What they receive |
|---|---|---|
| Energy Restriction | Experimental | Not described Receives: Other: Energy Restriction |
| Sleep Deprivation | Experimental | Not described Receives: Other: Sleep Deprivation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Energy RestrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Collaborators
- United States Army Natick Soldier Research Development and Engineering Center, Massachusetts Institute of Technology
- Responsible party
- Principal investigator, Harris R. Lieberman, United States Army Research Institute of Environmental Medicine
- Investigators
- Harris R. Lieberman, PhD, Principal investigator, US Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603550
- Sponsor's protocol ID
- H10-09
- Status last verified
- Oct 2016
- First submitted
- 18 May 2012
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27807037Karl 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.
PubMed 26975533O'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.
PubMed 26740683
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Energy and Cognition
- ClinicalTrials.gov ID
- NCT01603550
- Acronym / sponsor ID
- H10-09
- Conditions
- Energy Restriction, Sleep Deprivation
- Keywords
- energy restriction, sleep deprivation, cognitive performance, brain function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Collaborators
- United States Army Natick Soldier Research Development and Engineering Center, Massachusetts Institute of Technology
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Energy Restriction | Experimental | Other: Energy Restriction |
| Sleep Deprivation | Experimental | Other: Sleep Deprivation |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep DeprivationSleep Deprivation | Other | Sleep Deprivation |
| Energy RestrictionEnergy Restriction | Other | Energy Restriction |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Derived from this study: PubMed 27807037Lieberman 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.
- Derived from this study: PubMed 26975533Karl 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.
- Derived from this study: PubMed 26740683O'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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harris R. Lieberman, PhD principal investigator
US Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Deprivation and Energy Restriction in people with Energy Restriction and Sleep Deprivation, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01603550, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2016.