Cardiovascular Diseases, Dyslipidemias, Hypertension, Type 2 Diabetes
Conditions
Keywords
Diet Quality, Healthy Eating Index, Body Composition, Dietary Supplements, Gut Microbiome, Army Combat Fitness Test
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=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.
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.
Interventions
None listed
Sponsors
Pennington Biomedical Research Center
U.S. Army Medical Research and Development Command
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dietary intake | This study will collect one ASA24® recall at visit 1 and a second follow-up 24-hour recall 3-10 days later | 24-hour dietary recalls will be collected using ASA24® to measure intake of macronutrients (protein, carbohydrate, and fat) and micronutrients (vitamins and minerals). |
| Dietary quality | This study will collect one ASA24® recall at visit 1 and a second follow-up 24-hour recall 3-10 days later | 24-hour dietary recalls will be collected using ASA24®. Diet quality will be assessed by the healthy eating index (HEI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). | Depression will be assessed by the Patient Health Questionnaire-9 (PHQ-9). |
| Anxiety | Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). | Anxiety will be assessed by the General Anxiety Disorder-7 (GAD-7) questionnaire. |
| Resilience | Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). | Resilience will be assessed by the Connor-Davidson Resilience Scale (CD-RISC). |
| Posttraumatic stress disorder | Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). | Posttraumatic stress disorder (PTSD) will be assessed by the the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5). |
| Self-efficacy | Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). | Self-efficacy will be assessed by the Generalized Self-Efficacy Scale (GSE). |
| Mood | Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). | Mood state will be assessed by the Profile of Mood States 2 (POMS2) questionnaire. |
| Physical activity | ActiGraphs will be administered 0-7 days after study enrollment and worn continuously for 5-7 days. | Physical activity will be measured using the ActiGraph wGT3X-BT wearable device. |
| Physical performance | Data will be collected one time at visit 1 (within 1-2 weeks of study enrollment). | Participants will self-report their most recent Army Combat Fitness Test (ACFT) results. |
| Physical injuries | Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). | A questionnaire on orthopedic injuries will be administered. |
| Sleep duration and quality | ActiGraphs will be administered 0-7 days after study enrollment and worn continuously for 5-7 days. | Sleep duration and quality will be measured using the ActiGraph wGT3X-BT wearable device. |
| Eating behavior (Satiety) | Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). | Assessed using the Satiety scale derived from the validated Military Eating Behavior Survey (MEBS) |
| Eating behavior (Fast Eating Rate) | Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). | Assessed using the Fast Eating Rate scale derived from the validated Military Eating Behavior Survey (MEBS) |
| Eating behavior (Slow Eating Rate) | Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). | Assessed using the Slow Eating Rate scale derived from the validated Military Eating Behavior Survey (MEBS) |
| Blood pressure | Measured one time at visit 1 (within 1-2 weeks of study enrollment). | Measured after an overnight (at least 10 hour) fast, blood pressure will be measured with an automated cuff. |
| Anthropometric and body composition measures | Measured one time at visit 1 (within 1-2 weeks of study enrollment). | 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. |
| Measures of anemia and iron status, nutrient status, hormone status, stress, cardiometabolic health, and inflammation | Measured one time at visit 1 (within 1-2 weeks of study enrollment). | Measured in blood |
| Albumin, iodine, and other biomarkers of health | Measured one time at visit 1 (within 1-2 weeks of study enrollment). | Measured in urine |
| Gut microbiome composition | Measured one time at visit 1 (within 1-2 weeks of study enrollment). | Measured in stool |
| Prescription and over-the-counter medication and supplement use | 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 | 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. |
| Resting metabolic rate (RMR) | Measured one time at visit 1 (within 1-2 weeks of study enrollment). | Measured by indirect calorimetry (MedGem or BodyGem indirect calorimeter). |
| Heart rate variability (HRV) | Measured one time at visit 1 (within 1-2 weeks of study enrollment). | Heart rate variations will be continuously recorded for 10 minutes with the Zephyr Bioharness™ (Zephyr Technology Corporation, Annapolis, MD, US). |
| Genomics | Measured one time at visit 1 (within 1-2 weeks of study enrollment). | Array-based genotyping using blood samples |
| Hemoglobin mass and blood volume | Measured one time at visit 1 (within 1-2 weeks of study enrollment). | 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. |
| Total daily energy expenditure (TDEE) | Measured three times, twice at visit 1 (within 1-2 weeks of study enrollment) and third time at day 7. | 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. |
| Psychomotor Vigilance Test (PVT) | Test will be administered one time at visit 1 (within 1-2 weeks of study enrollment). | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORClaire E Berryman, PhD, RD
Pennington Biomedical Research Center
Outcome results
None listed