Cognitive ImpairmentNCT04250480
Changes in Cognition During a 24-h Simulated Military Operation
A study testing beta-alanine in people with Cognitive Impairment, run by University of Central Florida at 1 site in United States.
Trial summary
Sustained military operations (SUSOPs) result in psychological stress and cognitive dysfunction, which may be related to the recruitment of classical monocytes into the brain. Goals: To investigate the effect of sustained-release beta-alanine on changes in cognition and markers of immune cell recruitment during a… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- beta-alanine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2017to 15 Apr 2018
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants in this study will be males aged 18-35, preferably with military training or are current Reserve Officers' Training Corps cadets
- Free of any physical limitations (determined by medical and activity history questionnaire [MHQ] and the physical activity readiness questionnaire [PAR-Q+]).
- Participants will be required to be recreationally-active (defined according to American College of Sports Medicine standards of at least 150 minutes exercise per week).
- Participants must be willing abstain from dietary supplementation throughout the duration of the study.
- Participant understands the study procedures and signs forms providing informed consent to participate in the study.
Who cannot join
- Individual does not provide consent to participate in this study.
- Inability to perform physical exercise (determined by health and activity questionnaire [MHQ] and physical activity readiness questionnaire [PAR-Q+]). That is Answering "Yes" to any question on the PAR-Q+, or having a pre-existing condition such as musculoskeletal injury, back pain, chronic pain etc. that the investigative team perceives will prevent a participant from safely completing the protocol.
- Taking any other nutritional supplement or performance-enhancing drug (determined from health and activity questionnaire).
- Regularly taking any type of prescription or over-the-counter medication, or having any chronic illnesses, which require medical care.
- Inability to complete any of the exercise performance testing on the familiarization day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Cognition During a 24-h Simulated Military Operation (SUSOP). Influence of β-alanine Supplementation and Markers of Classical Monocyte Recruitment
Sustained military operations (SUSOPs) result in psychological stress and cognitive dysfunction, which may be related to the recruitment of classical monocytes into the brain.
Goals:
- To investigate the effect of sustained-release beta-alanine on changes in cognition and markers of immune cell recruitment during a 24-hour simulated military operation.
- To examine associations between changes cognition and changes in markers mediating immune cell recruitment.
Read the detailed description
Sustained military operations (SUSOPs) expose soldiers to a multitude of stressors, including sustained physical activity, caloric deficit, and sleep deprivation. Several studies have shown that the combination of these factors result in psychological stress, which often leads to significant cognitive impairment.
Psychological stress has been shown to result in activation of neuroendocrine pathways that signal into the periphery and relay information from the brain to the immune system. This process is generally characterized by elevations of several key pro-inflammatory cytokines, chemokines, secondary messengers and reactive oxygen species. Notably, peripheral classical monocytes are reported to undergo recruitment to the brain during periods of psychological stress following priming by cytokines secreted from activated microglia.
Carnosine, an endogenous dipeptide consisting of beta-alanine and L-histidine, has been shown to inhibit the synthesis of inflammatory and oxidative mediators in microglia in vitro. Beta-alanine, which is the rate limiting amino acid in carnosine formation has been shown to increase carnosine concentrations in various regions of the brain in rodents which been associated with biochemical changes that resulted in favorable improvements in resilience to stress exposure. However, data on the effects of beta-alanine supplementation on cognition in humans is less clear. Further, the effect of beta-alanine supplementation on systemic and cellular mediators of monocyte recruitment has not been examined.
Goals:
- To investigate the effect of sustained-release beta-alanine on changes in psychological stress and cognition using Automated Neuropsychological Assessment Metric (ANAM) cognitive assessments during a 24-hour simulated military operation.
- To examine the effect of sustained-release beta-alanine on monocyte chemoattractant protein-1 (MCP-1), interleukin-8, Lymphocyte function-associated antigen-1 (CD11a), macrophage-1-antigen (CD11b) expression and C-C chemokine receptor 2 (CCR2) expression on neutrophils and classical monocytes during a 24-hour simulated military operation.
- To examine associations between MCP-1, interleukin-8, CD11a, CD11b, CCR2 and a composite measure of cognition derived from ANAM assessment scores during a 24-hour simulated military operation.
Method:
Double-blind placebo controlled trial compared the effect of supplementation with sustained release beta-alanine (12 grams per day) versus placebo (equivalent amount of rice powder) on cognition and monocyte responses during a 24-hour simulated military operation consisting of sleep-restriction, caloric restriction, and acute and sustained periods military specific physical activity.
Supplementation occurred over a period of 14 days prior to completion of the simulated military operation. ANAM tests were assessed and blood samples taken upon arrival to the lab for the 24 hour simulated operation (0 hours) and at 12, 18 and 24 hours during the SUSOP.
- Conditions
- Cognitive Impairment
- Being tested
- beta-alanine, placebo
- Keywords
- beta-alanine, immune cells
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beta-alanineDietary supplement
beta-alanine tablet
placeboDietary supplement
rice powder tablet
| Study group | Role | What they receive |
|---|---|---|
| Beta-alanine | Experimental | 4 g by mouth, 3 times per day with regular meals for 14 days. Receives: Dietary Supplement: beta-alanine |
| Placebo | Placebo comparator | 4 g by mouth, 3 times per day with regular meals for 14 days. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms checklist
monitor frequency and severity of subjective symptoms related to a broad spectrum of conditions. The participant is presented with 21 symptoms. The participant is required to rate each symptom (e.g. fatigue, headache, Nausea, numbness/tingling etc. on a scale from 0 (Not Present) to 6 (Severe)
Measured: Change from 0 at 12, 18 and 24 hours
COGcomp (composite measure of cognition)
Throughput (TP) scores from each of seven cognitive assessments administered as part of a battery of tests via Automated Neuropsychological Assessment Metrics (ANAM) computer software. Tests include:
- Simple reaction time
- Code Substitution
- Procedural Reaction Time
- Mathematical processing
- Matching to sample
- Code substitution Delayed
- Simple reaction time repeat
Measured: Change from 0 at 12, 18 and 24 hours
Monocyte chemoattractant protein-1 (MCP-1)
Serum concentrations of MCP-1
Measured: Change from 0 at 12, 18 and 24 hours
Macrophage-1-antigen (CD11b)
Surface expression of CD11b on classical monocytes and neutrophils
Measured: Change from 0 at 12, 18 and 24 hours
C-C chemokine receptor 2 (CCR2)
Surface expression of CCR2 on classical monocytes
Measured: Change from 0 at 12, 18 and 24 hours
Interleukin-8
Serum concentrations of interleukin-8
Measured: Change from 0 at 12, 18 and 24 hours
Lymphocyte function-associated antigen-1 (CD11a)
Surface expression of CD11a on classical monocytes and neutrophils
Measured: Change from 0 at 12, 18 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start2 Oct 2017
- Primary completion15 Apr 2018
- Study completion15 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Strength and Conditioning Association
- Responsible party
- Principal investigator, Adam Wells, University of Central Florida
- Investigators
- Adam J Wells, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250480
- Sponsor's protocol ID
- SBE-17-13223
- Status last verified
- Jan 2020
- First submitted
- 29 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cognition During a 24-h Simulated Military Operation (SUSOP). Influence of β-alanine Supplementation and Markers of Classical Monocyte Recruitment
- ClinicalTrials.gov ID
- NCT04250480
- Acronym / sponsor ID
- SBE-17-13223
- Conditions
- Cognitive Impairment
- Keywords
- beta-alanine, immune cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- National Strength and Conditioning Association
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 15 Apr 2018 (actual)
- First posted
- 31 Jan 2020 (actual)
- 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.
Sustained military operations (SUSOPs) result in psychological stress and cognitive dysfunction, which may be related to the recruitment of classical monocytes into the brain.
Goals:
- To investigate the effect of sustained-release beta-alanine on changes in cognition and markers of immune cell recruitment during a 24-hour simulated military operation.
- To examine associations between changes cognition and changes in markers mediating immune cell recruitment.
Detailed description
Sustained military operations (SUSOPs) expose soldiers to a multitude of stressors, including sustained physical activity, caloric deficit, and sleep deprivation. Several studies have shown that the combination of these factors result in psychological stress, which often leads to significant cognitive impairment.
Psychological stress has been shown to result in activation of neuroendocrine pathways that signal into the periphery and relay information from the brain to the immune system. This process is generally characterized by elevations of several key pro-inflammatory cytokines, chemokines, secondary messengers and reactive oxygen species. Notably, peripheral classical monocytes are reported to undergo recruitment to the brain during periods of psychological stress following priming by cytokines secreted from activated microglia.
Carnosine, an endogenous dipeptide consisting of beta-alanine and L-histidine, has been shown to inhibit the synthesis of inflammatory and oxidative mediators in microglia in vitro. Beta-alanine, which is the rate limiting amino acid in carnosine formation has been shown to increase carnosine concentrations in various regions of the brain in rodents which been associated with biochemical changes that resulted in favorable improvements in resilience to stress exposure. However, data on the effects of beta-alanine supplementation on cognition in humans is less clear. Further, the effect of beta-alanine supplementation on systemic and cellular mediators of monocyte recruitment has not been examined.
Goals:
- To investigate the effect of sustained-release beta-alanine on changes in psychological stress and cognition using Automated Neuropsychological Assessment Metric (ANAM) cognitive assessments during a 24-hour simulated military operation.
- To examine the effect of sustained-release beta-alanine on monocyte chemoattractant protein-1 (MCP-1), interleukin-8, Lymphocyte function-associated antigen-1 (CD11a), macrophage-1-antigen (CD11b) expression and C-C chemokine receptor 2 (CCR2) expression on neutrophils and classical monocytes during a 24-hour simulated military operation.
- To examine associations between MCP-1, interleukin-8, CD11a, CD11b, CCR2 and a composite measure of cognition derived from ANAM assessment scores during a 24-hour simulated military operation.
Method:
Double-blind placebo controlled trial compared the effect of supplementation with sustained release beta-alanine (12 grams per day) versus placebo (equivalent amount of rice powder) on cognition and monocyte responses during a 24-hour simulated military operation consisting of sleep-restriction, caloric restriction, and acute and sustained periods military specific physical activity.
Supplementation occurred over a period of 14 days prior to completion of the simulated military operation. ANAM tests were assessed and blood samples taken upon arrival to the lab for the 24 hour simulated operation (0 hours) and at 12, 18 and 24 hours during the SUSOP.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-alanine | Experimental | Dietary Supplement: beta-alanine4 g by mouth, 3 times per day with regular meals for 14 days. |
| Placebo | Placebo comparator | Dietary Supplement: placebo4 g by mouth, 3 times per day with regular meals for 14 days. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants in this study will be males aged 18-35, preferably with military training or are current Reserve Officers' Training Corps cadets
- Free of any physical limitations (determined by medical and activity history questionnaire [MHQ] and the physical activity readiness questionnaire [PAR-Q+]).
- Participants will be required to be recreationally-active (defined according to American College of Sports Medicine standards of at least 150 minutes exercise per week).
- Participants must be willing abstain from dietary supplementation throughout the duration of the study.
- Participant understands the study procedures and signs forms providing informed consent to participate in the study.
Key exclusion criteria (5 listed)
- Individual does not provide consent to participate in this study.
- Inability to perform physical exercise (determined by health and activity questionnaire [MHQ] and physical activity readiness questionnaire [PAR-Q+]). That is Answering "Yes" to any question on the PAR-Q+, or having a pre-existing condition such as musculoskeletal injury, back pain, chronic pain etc. that the investigative team perceives will prevent a participant from safely completing the protocol.
- Taking any other nutritional supplement or performance-enhancing drug (determined from health and activity questionnaire).
- Regularly taking any type of prescription or over-the-counter medication, or having any chronic illnesses, which require medical care.
- Inability to complete any of the exercise performance testing on the familiarization day.
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 |
|---|---|---|
| beta-alaninebeta-alanine tablet | Dietary supplement | Beta-alanine |
| placeborice powder tablet | Dietary supplement | Placebo |
Primary outcome
Symptoms checklist
Time frame: Change from 0 at 12, 18 and 24 hours
monitor frequency and severity of subjective symptoms related to a broad spectrum of conditions. The participant is presented with 21 symptoms. The participant is required to rate each symptom (e.g. fatigue, headache, Nausea, numbness/tingling etc. on a scale from 0 (Not Present) to 6 (Severe)
COGcomp (composite measure of cognition)
Time frame: Change from 0 at 12, 18 and 24 hours
Throughput (TP) scores from each of seven cognitive assessments administered as part of a battery of tests via Automated Neuropsychological Assessment Metrics (ANAM) computer software. Tests include: 1. Simple reaction time 2. Code Substitution 3. Procedural Reaction Time 4. Mathematical processing 5. Matching to sample 6. Code substitution Delayed 7. Simple reaction time repeat
Monocyte chemoattractant protein-1 (MCP-1)
Time frame: Change from 0 at 12, 18 and 24 hours
Serum concentrations of MCP-1
Macrophage-1-antigen (CD11b)
Time frame: Change from 0 at 12, 18 and 24 hours
Surface expression of CD11b on classical monocytes and neutrophils
C-C chemokine receptor 2 (CCR2)
Time frame: Change from 0 at 12, 18 and 24 hours
Surface expression of CCR2 on classical monocytes
Interleukin-8
Time frame: Change from 0 at 12, 18 and 24 hours
Serum concentrations of interleukin-8
Lymphocyte function-associated antigen-1 (CD11a)
Time frame: Change from 0 at 12, 18 and 24 hours
Surface expression of CD11a on classical monocytes and neutrophils
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 31 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Adam J Wells, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beta-alanine in people with Cognitive Impairment, run by University of Central Florida 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 5 inclusion and 5 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 31 Jan 2020. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Symptoms checklist (time frame: Change from 0 at 12, 18 and 24 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2020.