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HypertensionMHANESNCT06380322

Military Health and Nutrition Examination Study

An observational study of Hypertension and Type 2 Diabetes, run by Pennington Biomedical Research Center at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hypertension, Type 2 Diabetes, Dyslipidemias
How many people
648 participants
Where
6 sitesUnited States
Study dates
24 Aug 2024to 1 Feb 2026
Phase
Observational
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Active-duty U.S. Army Soldiers (n=600 completers)

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

  • Fort Campbell

    Fort Campbell, Kentucky, 42223

  • 4th Infantry Division & Fort Carson

    Fort Carson, Colorado, 80913

  • Fort Stewart

    Hinesville, Georgia, 31314

  • Joint Base Lewis-McChord

    Joint Base Lewis McChord, Washington, 98431

  • Fort Johnson

    Leesville, Louisiana, 71459

Other trials in United States

About this study

Official title: Stand Ready: Military Health and Nutrition Examination Study

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=650), 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.

Read the 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.

Keywords
Diet Quality, Healthy Eating Index, Body Composition, Dietary Supplements, Gut Microbiome, Army Combat Fitness Test
Medical subject headings
Hypertension, Diabetes Mellitus, Type 2, Dyslipidemias, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06380322
Study groupRoleWhat they receive
Active-duty Army Service MembersAll measures will be collected one time during the study, except for the dietary recall (measured two times) and urine sample for total daily energy expenditure using doubly labeled water method (measured 3 time).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dietary intake

    24-hour dietary recalls will be collected using ASA24® to measure intake of macronutrients (protein, carbohydrate, and fat) and micronutrients (vitamins and minerals).

    Measured: This study will collect one ASA24® recall at visit 1 and a second follow-up 24-hour recall 3-10 days later

  2. Dietary quality

    24-hour dietary recalls will be collected using ASA24®. Diet quality will be assessed by the healthy eating index (HEI).

    Measured: This study will collect one ASA24® recall at visit 1 and a second follow-up 24-hour recall 3-10 days later

Secondary outcomes (27)

  1. Depression

    Depression will be assessed by the Patient Health Questionnaire-9 (PHQ-9).

    Measured: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).

  2. Anxiety

    Anxiety will be assessed by the General Anxiety Disorder-7 (GAD-7) questionnaire.

    Measured: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).

  3. Resilience

    Resilience will be assessed by the Connor-Davidson Resilience Scale (CD-RISC).

    Measured: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).

  4. Posttraumatic stress disorder

    Posttraumatic stress disorder (PTSD) will be assessed by the the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).

    Measured: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).

  5. Self-efficacy

    Self-efficacy will be assessed by the Generalized Self-Efficacy Scale (GSE).

    Measured: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).

  6. Mood

    Mood state will be assessed by the Profile of Mood States 2 (POMS2) questionnaire.

    Measured: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).

  7. Physical activity

    Physical activity will be measured using the ActiGraph wGT3X-BT wearable device.

    Measured: ActiGraphs will be administered 0-7 days after study enrollment and worn continuously for 5-7 days.

  8. Physical activity

    Physical activity will be assessed by the Physical Activity and Physical Fitness Questionnaire from NHANES.

    Measured: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).

  9. Physical performance

    Participants will self-report their most recent Army Combat Fitness Test (ACFT) results.

    Measured: Data will be collected one time at visit 1 (within 1-2 weeks of study enrollment).

  10. Physical injuries

    A questionnaire on orthopedic injuries will be administered.

    Measured: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).

  11. Sleep duration and quality

    Sleep duration and quality will be measured using the ActiGraph wGT3X-BT wearable device.

    Measured: ActiGraphs will be administered 0-7 days after study enrollment and worn continuously for 5-7 days.

  12. Sleep duration and quality

    Sleep duration and quality will be assessed by using the Pittsburgh Sleep Quality Index (PSQI).

    Measured: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).

  13. Eating behavior (Satiety)

    Assessed using the Satiety scale derived from the validated Military Eating Behavior Survey (MEBS)

    Measured: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).

  14. Eating behavior (Fast Eating Rate)

    Assessed using the Fast Eating Rate scale derived from the validated Military Eating Behavior Survey (MEBS)

    Measured: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).

  15. Eating behavior (Slow Eating Rate)

    Assessed using the Slow Eating Rate scale derived from the validated Military Eating Behavior Survey (MEBS)

    Measured: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).

  16. Blood pressure

    Measured after an overnight (at least 10 hour) fast, blood pressure will be measured with an automated cuff.

    Measured: Measured one time at visit 1 (within 1-2 weeks of study enrollment).

  17. Anthropometric and body composition measures

    Height measured using a stadiometer. Body mass and composition (fat mass, percent fat, fat-free mass, skeletal muscle mass, and body water) using bioelectrical impedance analysis, body image scanning, and neck, waist, and hip circumference measurements. If available, at 1-2 Army bases, dual x-ray absorptiometry (DXA) will be used.

    Measured: Measured one time at visit 1 (within 1-2 weeks of study enrollment).

  18. Measures of anemia and iron status, nutrient status, hormone status, stress, cardiometabolic health, and inflammation

    Measured in blood

    Measured: Measured one time at visit 1 (within 1-2 weeks of study enrollment).

  19. Albumin, iodine, and other biomarkers of health

    Measured in urine

    Measured: Measured one time at visit 1 (within 1-2 weeks of study enrollment).

  20. Gut microbiome composition

    Measured in stool

    Measured: Measured one time at visit 1 (within 1-2 weeks of study enrollment).

  21. Prescription and over-the-counter medication and supplement use

    Volunteers will be asked the name of each supplement and medication used in the past 30 days and the dose, unit, frequency, route, indication, and start/stop date. An opaque bag will be provided to volunteers to transport supplements to the in-person visit. Dietary supplement use will also be assessed by ASA24® in conjunction with the 24-hour dietary recall.

    Measured: 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

  22. Resting metabolic rate (RMR)

    Measured by indirect calorimetry (MedGem or BodyGem indirect calorimeter).

    Measured: Measured one time at visit 1 (within 1-2 weeks of study enrollment).

  23. Heart rate variability (HRV)

    Heart rate variations will be continuously recorded for 10 minutes with the Zephyr Bioharness™ (Zephyr Technology Corporation, Annapolis, MD, US).

    Measured: Measured one time at visit 1 (within 1-2 weeks of study enrollment).

  24. Genomics

    Array-based genotyping using blood samples

    Measured: Measured one time at visit 1 (within 1-2 weeks of study enrollment).

  25. Hemoglobin mass and blood volume

    Hemoglobin mass (Hbmass) will be determined in a subset of participants using the automated CO-rebreathing method. The method is based on the dilution principle where a small volume of tracer (CO) is administered and the subsequent concentration of carboxyhemoglobin (COHb) in the blood allows for calculation of Hbmass.

    Measured: Measured one time at visit 1 (within 1-2 weeks of study enrollment).

  26. Total daily energy expenditure (TDEE)

    Total daily energy expenditure will be assessed by the Doubly Labeled Water (DLW) method. Prior to dosing, volunteers will provide a urine sample that will be used to measure background isotope enrichment. Urine will be collected at 4.5 h and 7 d after dosing. Isotopic elimination rates will be calculated to get the rate of CO2 production. Energy expenditure will be calculated by multiplying the rate of CO2 production by an assumed food quotient of the diet.

    Measured: Measured three times, twice at visit 1 (within 1-2 weeks of study enrollment) and third time at day 7.

  27. Psychomotor Vigilance Test (PVT)

    This is a 5-min test of simple visual reaction time widely used to assess alertness. The test requires volunteers to sustain attention and respond to stimuli presented at random intervals on a computer screen by pressing a button. Parameters recorded include reaction time, premature responses, correct responses, and number of lapses.

    Measured: Test will be administered one time at visit 1 (within 1-2 weeks of study enrollment).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2024
  2. Study start24 Aug 2024
  3. Primary completion1 Feb 2026
  4. Study completion1 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
648 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06380322
Sponsor's protocol ID
PBRC 2023-034
Acronym
MHANES
Status last verified
Jul 2026
First submitted
30 Mar 2024
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Karl JP, Margolis LM, Fallowfield JL, Child RB, Martin NM, McClung JP. Military nutrition research: Contemporary issues, state of the science and future directions. Eur J Sport Sci. 2022 Jan;22(1):87-98. doi: 10.1080/17461391.2021.1930192. Epub 2021 Jun 3.

    PubMed 33980120

  • Nindl BC, Jaffin DP, Dretsch MN, Cheuvront SN, Wesensten NJ, Kent ML, Grunberg NE, Pierce JR, Barry ES, Scott JM, Young AJ, O'Connor FG, Deuster PA. Human Performance Optimization Metrics: Consensus Findings, Gaps, and Recommendations for Future Research. J Strength Cond Res. 2015 Nov;29 Suppl 11:S221-45. doi: 10.1519/JSC.0000000000001114.

    PubMed 26506192

  • Rittenhouse M, Scott J, Deuster P. Healthy Eating Index and Nutrition Biomarkers among Army Soldiers and Civilian Control Group Indicate an Intervention Is Necessary to Raise Omega-3 Index and Vitamin D and Improve Diet Quality. Nutrients. 2020 Dec 31;13(1):122. doi: 10.3390/nu13010122.

    PubMed 33396252

  • Eilerman PA, Herzog CM, Luce BK, Chao SY, Walker SM, Zarzabal LA, Carnahan DH. A comparison of obesity prevalence: military health system and United States populations, 2009-2012. Mil Med. 2014 May;179(5):462-70. doi: 10.7205/MILMED-D-13-00430.

    PubMed 24806489

  • Clutter CA, Beckman DJ, Wardian JL, Rittel AG, True MW. Are We Missing an Opportunity? Prediabetes in the U.S. Military. Mil Med. 2024 Jan 23;189(1-2):326-331. doi: 10.1093/milmed/usac197.

    PubMed 35786769

  • Chao SY, Zarzabal LA, Walker SM, Herzog CM, Eilerman PA, Luce BK, Carnahan DH. Estimating diabetes prevalence in the Military Health System population from 2006 to 2010. Mil Med. 2013 Sep;178(9):986-93. doi: 10.7205/MILMED-D-13-00147.

    PubMed 24005548

  • Herzog CM, Chao SY, Eilerman PA, Luce BK, Carnahan DH. Metabolic syndrome in the Military Health System based on electronic health data, 2009-2012. Mil Med. 2015 Jan;180(1):83-90. doi: 10.7205/MILMED-D-14-00039.

    PubMed 25562862

  • Shrestha A, Ho TE, Vie LL, Labarthe DR, Scheier LM, Lester PB, Seligman MEP. Comparison of Cardiovascular Health Between US Army and Civilians. J Am Heart Assoc. 2019 Jun 18;8(12):e009056. doi: 10.1161/JAHA.118.009056. Epub 2019 Jun 5.

    PubMed 31164033

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PubMed 11556941

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171

  • Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.

    PubMed 12964174

  • Prins A, Bovin MJ, Smolenski DJ, Marx BP, Kimerling R, Jenkins-Guarnieri MA, Kaloupek DG, Schnurr PP, Kaiser AP, Leyva YE, Tiet QQ. The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5): Development and Evaluation Within a Veteran Primary Care Sample. J Gen Intern Med. 2016 Oct;31(10):1206-11. doi: 10.1007/s11606-016-3703-5. Epub 2016 May 11.

    PubMed 27170304

  • Schwarzer, R. and Jerusalem, M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37). Windsor, UK: NFER-NELSON.

  • McNair DM, Lorr M, Droppleman LF. Profile of Mood States Manual. San Diego, CA: Educational and Industrial Testing Service. 1971.

  • US Department of the Army. (2017) Nutrition and Menu Standards for Human Performance Optimization. Army Regulation 40-25.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension and Type 2 Diabetes, run by Pennington Biomedical Research Center at 6 sites 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 3 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 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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.

What does the primary outcome measure?

Dietary intake (time frame: This study will collect one ASA24® recall at visit 1 and a second follow-up 24-hour recall 3-10 days later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06380322, which also lists 30 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 17 Jul 2026.

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