Clinical Trial on Cardiovascular Diseases, Hypertension, Dyslipidemias, Type 2 Diabetes - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

648

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24-hour dietary recalls will be collected using ASA24® to measure intake of macronutrients (protein, carbohydrate, and fat) and micronutrients (vitamins and minerals).	This study will collect one ASA24® recall at visit 1 and a second follow-up 24-hour recall 3-10 days later
Dietary quality 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).	This study will collect one ASA24® recall at visit 1 and a second follow-up 24-hour recall 3-10 days later

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

U.S. Army Medical Research and Development Command

Investigators

Principal Investigator: Claire E Berryman, PhD, RD, Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2024

Primary Completion (Actual)

February 1, 2026

Study Completion (Actual)

February 1, 2026

Study Registration Dates

First Submitted

March 30, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

PBRC 2023-034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Outcome Measure	Measure Description	Time Frame
Depression 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).	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Anxiety 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.	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Resilience 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).	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Posttraumatic stress disorder 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).	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Self-efficacy 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).	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Mood 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.	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Physical activity 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.	ActiGraphs will be administered 0-7 days after study enrollment and worn continuously for 5-7 days.
Physical activity 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.	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Physical performance 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.	Data will be collected one time at visit 1 (within 1-2 weeks of study enrollment).
Physical injuries 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.	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Sleep duration and quality 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.	ActiGraphs will be administered 0-7 days after study enrollment and worn continuously for 5-7 days.
Sleep duration and quality 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).	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Eating behavior (Satiety) 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)	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Eating behavior (Fast Eating Rate) 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)	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Eating behavior (Slow Eating Rate) 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)	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Blood pressure 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.	Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Anthropometric and body composition measures 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.	Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Measures of anemia and iron status, nutrient status, hormone status, stress, cardiometabolic health, and inflammation Time Frame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).	Measured in blood	Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Albumin, iodine, and other biomarkers of health Time Frame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).	Measured in urine	Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Gut microbiome composition Time Frame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).	Measured in stool	Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Prescription and over-the-counter medication and supplement use 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.	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
Resting metabolic rate (RMR) Time Frame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).	Measured by indirect calorimetry (MedGem or BodyGem indirect calorimeter).	Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Heart rate variability (HRV) 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).	Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Genomics Time Frame: Measured one time at visit 1 (within 1-2 weeks of study enrollment).	Array-based genotyping using blood samples	Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Hemoglobin mass and blood volume 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.	Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Total daily energy expenditure (TDEE) 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.	Measured three times, twice at visit 1 (within 1-2 weeks of study enrollment) and third time at day 7.
Psychomotor Vigilance Test (PVT) 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.	Test will be administered one time at visit 1 (within 1-2 weeks of study enrollment).

Military Health and Nutrition Examination Study (MHANES)

Stand Ready: Military Health and Nutrition Examination Study