CClinicalTrials.gg
CompletedNCT06380322MHANESUpdated Jul 17, 2026

Military Health and Nutrition Examination Study

An observational study in Hypertension, Type 2 Diabetes and Dyslipidemias, sponsored by Pennington Biomedical Research Center. Completed at 6 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by Pennington Biomedical Research Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
648
Ages
18 Years and older
Sex
All
01

Study 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=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.

02

Conditions studied

  • Hypertension
  • Type 2 Diabetes
  • Dyslipidemias
  • Cardiovascular Diseases

Keywords

  • Diet Quality
  • Healthy Eating Index
  • Body Composition
  • Dietary Supplements
  • Gut Microbiome
  • Army Combat Fitness Test
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 648 is above the median of 210 across 1,359 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

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

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)
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
648 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Active-duty Army Service Members

    All 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).

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What researchers measure

Primary outcomes

  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).

    Time frame: 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).

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

Secondary outcomes

  1. Depression

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

    Time frame: 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.

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

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

  19. Albumin, iodine, and other biomarkers of health

    Measured in urine

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

  20. Gut microbiome composition

    Measured in stool

    Time frame: 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.

    Time frame: 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).

    Time frame: 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).

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

  24. Genomics

    Array-based genotyping using blood samples

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

07

Study locations

6 sites
  • 4th Infantry Division & Fort Carson
    Fort Carson, Colorado 80913, United States
  • Fort Stewart
    Hinesville, Georgia 31314, United States
  • Fort Campbell
    Fort Campbell, Kentucky 42223, United States
  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana 70808, United States
  • Fort Johnson
    Leesville, Louisiana 71459, United States
  • Joint Base Lewis-McChord
    Joint Base Lewis McChord, Washington 98431, United States
08

References and documents

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.
  • Knapik JJ, Reynolds KL, Hoedebecke KL. Stress Fractures: Etiology, Epidemiology, Diagnosis, Treatment, and Prevention. J Spec Oper Med. 2017 Summer;17(2):120-130. doi: 10.55460/SPMB-1E6L. PubMed 28599045 ↗
  • Farina EK, Thompson LA, Knapik JJ, Pasiakos SM, McClung JP, Lieberman HR. Physical performance, demographic, psychological, and physiological predictors of success in the U.S. Army Special Forces Assessment and Selection course. Physiol Behav. 2019 Oct 15;210:112647. doi: 10.1016/j.physbeh.2019.112647. Epub 2019 Aug 8. PubMed 31401079 ↗
  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. PubMed 2748771 ↗
  • Cole RE, Jayne JM, O'Connor K, McGraw SM, Beyl R, DiChiara AJ, Karl JP. Development and Validation of the Military Eating Behavior Survey. J Nutr Educ Behav. 2021 Sep;53(9):798-810. doi: 10.1016/j.jneb.2021.04.467. Epub 2021 Jun 30. PubMed 34215517 ↗
  • Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. PubMed 18929686 ↗
  • Gibson AL, Holmes JC, Desautels RL, Edmonds LB, Nuudi L. Ability of new octapolar bioimpedance spectroscopy analyzers to predict 4-component-model percentage body fat in Hispanic, black, and white adults. Am J Clin Nutr. 2008 Feb;87(2):332-8. doi: 10.1093/ajcn/87.2.332. PubMed 18258622 ↗
  • Ling CH, de Craen AJ, Slagboom PE, Gunn DA, Stokkel MP, Westendorp RG, Maier AB. Accuracy of direct segmental multi-frequency bioimpedance analysis in the assessment of total body and segmental body composition in middle-aged adult population. Clin Nutr. 2011 Oct;30(5):610-5. doi: 10.1016/j.clnu.2011.04.001. Epub 2011 May 8. PubMed 21555168 ↗
  • WEIR JB. New methods for calculating metabolic rate with special reference to protein metabolism. J Physiol. 1949 Aug;109(1-2):1-9. doi: 10.1113/jphysiol.1949.sp004363. No abstract available. PubMed 15394301 ↗
  • Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available. PubMed 8598068 ↗
  • Tarvainen MP, Niskanen JP, Lipponen JA, Ranta-Aho PO, Karjalainen PA. Kubios HRV--heart rate variability analysis software. Comput Methods Programs Biomed. 2014;113(1):210-20. doi: 10.1016/j.cmpb.2013.07.024. Epub 2013 Aug 6. PubMed 24054542 ↗
  • Knapik JJ, Farina EK, Fulgoni VL, Lieberman HR. Clinically diagnosed iron and iodine deficiencies and disorders in the entire population of US military service members from 1997 to 2015. Public Health Nutr. 2021 Aug;24(11):3187-3195. doi: 10.1017/S1368980021000495. Epub 2021 Feb 5. PubMed 33541462 ↗
  • Knapik JJ, Farina EK, Fulgoni VL 3rd, Lieberman HR. Clinically-diagnosed vitamin deficiencies and disorders in the entire United States military population, 1997-2015. Nutr J. 2021 Jun 15;20(1):55. doi: 10.1186/s12937-021-00708-2. PubMed 34130698 ↗
  • Beal SL. Sample size determination for confidence intervals on the population mean and on the difference between two population means. Biometrics. 1989 Sep;45(3):969-77. PubMed 2790131 ↗
  • Lenth RV. Some Practical Guidelines for Effective Sample Size Determination. American Statistician. 2001;55:187-93.
  • Berryman CE, Bukhari AS, Rood JC, Hughes DA, Lowe AC, Niclou AM, Beckner ME, Weschenfelder C, Riley TM, Barney DE Jr, Dugan C, Bukhari SB, Bukhari FH, Smith MP, Turner BS, Sanford CM, Karl JP, McClung JP, Smith TJ, Owens BA, Beyl RA, Heymsfield SB, Greenway FL, Hennigar SR, Lieberman HR. Comprehensive Assessment of the Health and Nutritional Status of Active-Duty United States Army Soldiers: The Military Health and Nutrition Examination Study Protocol. Curr Dev Nutr. 2026 Jun 26;10(8):109420. doi: 10.1016/j.cdnut.2026.109420. eCollection 2026 Aug. PubMed 42529388 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06380322
Lead sponsor
Pennington Biomedical Research Center
Collaborators
U.S. Army Medical Research and Development Command
Responsible party
Claire Berryman (Assistant Professor, Pennington Biomedical Research Center) — Principal investigator
First posted
Apr 23, 2024
Start date
Aug 24, 2024
Primary completion
Feb 1, 2026
Completion
Feb 1, 2026
Last update
Jul 17, 2026

Study contacts

Claire E Berryman, PhD, RD
principal investigator · Pennington Biomedical Research Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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