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临床试验/NCT06380322
NCT06380322已完成不适用

Stand Ready: Military Health and Nutrition Examination Study

Pennington Biomedical Research Center9 个研究点 分布在 1 个国家目标入组 648 人开始时间: 2024年8月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
648
试验地点
9
主要终点
Dietary intake

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Dietary intake

时间窗: 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

时间窗: 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).

次要结局

  • 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)
  • Resting metabolic rate (RMR)(Measured one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Heart rate variability (HRV)(Measured one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Genomics(Measured one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Gut microbiome composition(Measured one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Physical injuries(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Eating behavior (Satiety)(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Eating behavior (Fast Eating Rate)(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Depression(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Anxiety(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Resilience(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Posttraumatic stress disorder(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Self-efficacy(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Mood(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Physical activity(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Physical performance(Data will be collected one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Eating behavior (Slow Eating Rate)(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Blood pressure(Measured one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Anthropometric and body composition measures(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(Measured one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Albumin, iodine, and other biomarkers of health(Measured one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Physical activity(ActiGraphs will be administered 0-7 days after study enrollment and worn continuously for 5-7 days.)
  • Sleep duration and quality(ActiGraphs will be administered 0-7 days after study enrollment and worn continuously for 5-7 days.)
  • Blood pressure(Measured one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Depression(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Anxiety(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Resilience(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Posttraumatic stress disorder(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Self-efficacy(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Mood(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Physical activity(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Physical performance(Data will be collected one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Physical injuries(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Sleep duration and quality(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Eating behavior (Satiety)(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Eating behavior (Fast Eating Rate)(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Eating behavior (Slow Eating Rate)(Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Anthropometric and body composition measures(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(Measured one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Albumin, iodine, and other biomarkers of health(Measured one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Gut microbiome composition(Measured one time at visit 1 (within 1-2 weeks of study enrollment).)
  • 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)
  • Resting metabolic rate (RMR)(Measured one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Heart rate variability (HRV)(Measured one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Genomics(Measured one time at visit 1 (within 1-2 weeks of study enrollment).)
  • Hemoglobin mass and blood volume(Measured one time at visit 1 (within 1-2 weeks of study enrollment).)
  • 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.)
  • Psychomotor Vigilance Test (PVT)(Test will be administered one time at visit 1 (within 1-2 weeks of study enrollment).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Claire Berryman

Assistant Professor

Pennington Biomedical Research Center

研究点 (9)

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