Effects of Severe Negative Energy Balance on Inflammation

NCT03524690 | Completed

• 1 other identifier: 18-06HC
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

• The effects of a simulated military operation on systemic inflammation

  Assessed using blood assays.

  6 hour measure

Secondary Outcomes (1)

• The effects of energy balance and severe energy deficit on inflammation during a simulated military operation

  6 hour measure

Study Arms (2)

SUSOPS Balance

ACTIVE COMPARATOR

Volunteers provided sufficient food to maintain energy balance.

Dietary Supplement: Energy Balance

SUSOPS Negative Balance

EXPERIMENTAL

Volunteers provided insufficient food to maintain energy balance resulting in negative energy balance.

Dietary Supplement: Negative Energy Balance

Interventions

Energy Balance DIETARY_SUPPLEMENT

Energy Balance Sufficient food provided to maintain energy balance.

SUSOPS Balance

Negative Energy Balance DIETARY_SUPPLEMENT

Negative Energy Balance Insufficient food provided to maintain energy balance resulting in negative energy balance.

SUSOPS Negative Balance

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead

Study Sites (1)

US Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

Location

Related Publications (1)

• Hennigar SR, McClung JP, Hatch-McChesney A, Allen JT, Wilson MA, Carrigan CT, Murphy NE, Teien HK, Martini S, Gwin JA, Karl JP, Margolis LM, Pasiakos SM. Energy deficit increases hepcidin and exacerbates declines in dietary iron absorption following strenuous physical activity: a randomized-controlled cross-over trial. Am J Clin Nutr. 2021 Feb 2;113(2):359-369. doi: 10.1093/ajcn/nqaa289.

  PMID: 33184627 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan M Pasiakos, PhD

  Military Nutrition Division, USARIEM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized, cross-over controlled trial

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 15, 2018
• Study Start: February 13, 2019
• Primary Completion: October 8, 2019
• Study Completion: October 8, 2019
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)