Effects of Severe Negative Energy Balance on Inflammation

Completed · Not applicable

Conditions studied: Inflammation

In brief

The effects of prolonged negative energy balance, commonly observed in sustained military training and combat operations, on systemic inflammatory responses has not been determined. To define the putative role of energy balance on inflammation and its downstream effects, we will conduct a controlled laboratory study that simulates extensive physiological stressors to determine if inflammation is exacerbated by underfeeding. This design will test the hypothesis that maintaining energy balance will attenuate systemic inflammation and its potential negative effects on whole-body metabolic homeostasis in response to physiological stressors.

Key facts

Study ID

NCT03524690

Run by

United States Army Research Institute of Environmental Medicine

People needed

13

Starts

2019-02-13

Expected to finish

2019-10-08

Last updated by the study team

2020-04-22

Who can join

Age: 18 and older, up to 39. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Men who are active duty military, aged 18 - 39 years
• Weight stable in the past 2 months (± 2.27 kg)
• Healthy without evidence of chronic illness, medication use, or musculoskeletal injury as determined by the USARIEM Office of Medical Support and Oversight (OMSO)
• Recreationally active (2-4 days per week aerobic and/or resistance exercise)
• Refrain from taking any pain-relievers (e.g., acetaminophen), nonsteroidal anti-inflammatory drugs (e.g., aspirin, Advil®, Aleve®, Naprosyn®), or any other aspirin-containing product for 10 days before starting and at least 5 days after completing the study
• Refrain from the use of alcohol and nicotine for the duration of the study
• Willing to refrain from alcohol, smoking any nicotine product (includes e-cigarettes), vaping, chewing tobacco, caffeine, and dietary supplement use, and from consumption of probiotic-containing foods (e.g., yogurt) throughout the entire study period (vitamin/mineral supplements cannot be taken for at least 2 weeks before starting the study)
• Supervisor approval for non-HRV Active Duty Military working within the US Army Natick Soldier Systems Center
• Reports having a bowel movement at least as frequently as every-other-day

You may not qualify if…

• Musculoskeletal injuries that compromise exercise capability
• Metabolic or cardiovascular abnormalities (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
• History of any disease or abnormality of the gastrointestinal tract including (but not limited to) diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis; or previous gastrointestinal surgery
• Anemic (plasma ferritin < 40 µg/L, hemoglobin < 13 g/dL) and Sickle Cell Anemia/Trait
• C-reactive protein (CRP) > 5 mg/dL
• Abnormal PT/PTT test or problems with blood clotting
• History of complications with lidocaine
• Evidence of any physical, mental, and/or medical conditions that would make the proposed studies relatively more hazardous as determined by OMSO
• Present condition of alcoholism or other substance abuse issues; use of anabolic steroids
• Blood donation within 4 months of beginning the study
• Oral antibiotic use within 3 months of participation
• Colonoscopy within 3 months of participation
• Use of laxatives, stool softeners, or anti-diarrheal medications more than once/month
• Currently using benzodiazepines, anti-depressants or anti-histamines
• Pacemaker or other implanted electronic medical device
• Are unwilling or unable to eat study diets and foods provided and/or follow exercise prescriptions

Where it is running

• US Army Research Institute of Environmental Medicine — Natick, Massachusetts, United States

Full record on ClinicalTrials.gov

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