Clinical trial NCT06380322: Military Health and Nutrition Examination Study
Official title: Stand Ready: Military Health and Nutrition Examination Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Type 2 Diabetes
Dyslipidemias
Cardiovascular Diseases
Keywords: Diet Quality
Healthy Eating Index
Body Composition
Dietary Supplements
Gut Microbiome
Army Combat Fitness Test
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2024-04-23
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Active-duty U.S. Army Soldiers (n=600 completers)

Brief summary: The Military Health and Nutrition Examination Study (MHANES) is a Department of Defense funded study conducted by Pennington Biomedical Research Center and the US Army Research Institute of Environmental Medicine. This cross-sectional study will assess, in a large, diverse sample of Army Service Members (n=600), food and supplement intake, cardiovascular health, body composition, biomarkers of nutritional status, measures of health status, injury prevalence, mental wellbeing, gut microbiome composition, and physical performance outcomes. The proposed study is modeled after the National Health and Nutrition Examination Survey (NHANES) and customized for the Army population.

Detailed description: Background: Comprehensive scientific data on dietary intake, nutritional status, cardiometabolic health, and performance of a representative sample of active-duty Soldiers are not available. Collecting such data will allow for assessment of disease prevalence and health status, provide novel descriptive information, and examine relationships between health and nutrition variables that are currently unavailable on the Army active-duty population.

Study Aim: To assess, in a large, diverse sample of Army Service Members, dietary intake, nutritional status, cardiovascular health, body composition, metabolic biomarkers of nutritional state, and other measures of health status.

Eligibility criteria: Inclusion Criteria:

* U.S. Army Soldiers ≥ 18 years old
* Willing to have biological samples stored for future use
* Willing to have data linked to the Soldier Performance, Health, and Readiness (SPHERE) database

Exclusion Criteria:

* Soldiers under the age of 18 years
* Soldiers with an inability to understand verbal or written instructions or testing materials in English
* Soldiers relocating or getting out of the Army in the next 30 days
* Pregnant females
* Soldiers currently in Basic Training (BCT) and/or One-Station Unit Training (OSUT)

Primary outcomes:
measure: Dietary intake
timeFrame: This study will collect one ASA24® recall at visit 1 and a second follow-up 24-hour recall 3-10 days later
measure: Dietary quality
timeFrame: This study will collect one ASA24® recall at visit 1 and a second follow-up 24-hour recall 3-10 days later
Secondary outcomes:
measure: Depression
timeFrame: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Anxiety
timeFrame: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Resilience
timeFrame: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Posttraumatic stress disorder
timeFrame: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Self-efficacy
timeFrame: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Mood
timeFrame: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Physical activity
timeFrame: ActiGraphs will be administered 0-7 days after study enrollment and worn continuously for 5-7 days.
measure: Physical activity
timeFrame: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Physical performance
timeFrame: Data will be collected one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Physical injuries
timeFrame: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Sleep duration and quality
timeFrame: ActiGraphs will be administered 0-7 days after study enrollment and worn continuously for 5-7 days.
measure: Sleep duration and quality
timeFrame: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Eating behavior (Satiety)
timeFrame: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Eating behavior (Fast Eating Rate)
timeFrame: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Eating behavior (Slow Eating Rate)
timeFrame: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Blood pressure
timeFrame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Anthropometric and body composition measures
timeFrame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Measures of anemia and iron status, nutrient status, hormone status, stress, cardiometabolic health, and inflammation
timeFrame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Albumin, iodine, and other biomarkers of health
timeFrame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Gut microbiome composition
timeFrame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Prescription and over-the-counter medication and supplement use
timeFrame: The information on current use of medications and dietary supplements will be obtained one time at visit 1 (within 1-2 weeks of study enrollment). ASA24® data will be collected at visit 1 and again 3-10 days later
measure: Resting metabolic rate (RMR)
timeFrame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Heart rate variability (HRV)
timeFrame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).
measure: Genomics
timeFrame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Other outcomes:
Locations:
city: Fort Campbell North
country: United States
facility: Fort Campbell
state: Kentucky
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Leesville
country: United States
facility: Fort Johnson
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Claire E Berryman, PhD, RD
role: PRINCIPAL_INVESTIGATOR
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