Gut Microbiota in Metabolic Surgery
NCT05000996
Bariatric Surgery Candidate, Body Weight
Nashville, Tennessee, United States
View Trial DetailsNCT Number: NCT06380322
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.
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Notify Me18 year and older
All sexes
Observational
4th Infantry Division & Fort Carson, Fort Carson, Colorado, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Physical activity will be assessed by the Physical Activity and Physical Fitness Questionnaire from NHANES.
Time frame: 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.
Time frame: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
A questionnaire on orthopedic injuries will be administered.
Time frame: 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.
Time frame: Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
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).
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).
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).
Assessed using the Slow Eating Rate scale derived from the validated Military Eating Behavior Survey (MEBS)
Time frame: 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.
Time frame: 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.
Time frame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Measured in blood
Time frame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Measured in urine
Time frame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Measured in stool
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
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: Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Measured by indirect calorimetry (MedGem or BodyGem indirect calorimeter).
Time frame: 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).
Time frame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Array-based genotyping using blood samples
Time frame: 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.
Time frame: 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.
Time frame: 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.
Pennington Biomedical Research Center
Other
Stand Ready: Military Health and Nutrition Examination Study
Acronym: MHANES
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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