Changes in Cognition During a 24-h Simulated Military Operation

NCT04250480 | Completed

• 1 other identifier: SBE-17-13223
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 24-hour simulated military operation.
• To examine associations between changes cognition and changes in markers mediating immune cell recruitment.

Conditions

Cognitive Impairment

Keywords

beta-alanine; immune cells

Outcome Measures

Primary Outcomes (7)

• 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)

  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: 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

  Change from 0 at 12, 18 and 24 hours

• Monocyte chemoattractant protein-1 (MCP-1)

  Serum concentrations of MCP-1

  Change from 0 at 12, 18 and 24 hours

• Macrophage-1-antigen (CD11b)

  Surface expression of CD11b on classical monocytes and neutrophils

  Change from 0 at 12, 18 and 24 hours

• C-C chemokine receptor 2 (CCR2)

  Surface expression of CCR2 on classical monocytes

  Change from 0 at 12, 18 and 24 hours

• Interleukin-8

  Serum concentrations of interleukin-8

  Change from 0 at 12, 18 and 24 hours

• Lymphocyte function-associated antigen-1 (CD11a)

  Surface expression of CD11a on classical monocytes and neutrophils

  Change from 0 at 12, 18 and 24 hours

Study Arms (2)

Beta-alanine

EXPERIMENTAL

4 g by mouth, 3 times per day with regular meals for 14 days.

Dietary Supplement: beta-alanine

Placebo

PLACEBO COMPARATOR

4 g by mouth, 3 times per day with regular meals for 14 days.

Dietary Supplement: placebo

Interventions

beta-alanine DIETARY_SUPPLEMENT

beta-alanine tablet

Beta-alanine

placebo DIETARY_SUPPLEMENT

rice powder tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Central Florida: lead
• National Strength and Conditioning Association: collaborator

Study Sites (1)

Kinesiology Research Labs

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

beta-Alanine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alanine; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Adam J Wells, PhD

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: October 2, 2017
• Primary Completion: April 15, 2018
• Study Completion: April 15, 2018
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)