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NCT03524690

Effects of Severe Negative Energy Balance on Inflammation

Completed NA Last updated 22 April 2020
What this trial tests

NA trial testing Energy Balance in Inflammation in 13 participants. Completed in 8 October 2019.

Timeline
13 February 2019
Primary endpoint
8 October 2019
8 October 2019

Quick facts

Lead sponsorUnited States Army Research Institute of Environmental Medicine
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposebasic science
Enrollment13
Start date13 February 2019
Primary completion8 October 2019
Estimated completion8 October 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

United States Army Research Institute of Environmental Medicine

Who can join

Adults 18 to 39, male only, with Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Energy deficit increases hepcidin and exacerbates declines in dietary iron absorption following strenuous physical activity: a randomized-controlled cross-over trial.
    Hennigar SR, McClung JP, Hatch-McChesney A, Allen JT, et al · · 2021 · cited 33× · PMID 33184627 · DOI 10.1093/ajcn/nqaa289

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Other trials of Energy Balance

Trials testing the same drug.

Other recruiting trials for Inflammation

Currently open trials in the same condition.

Other United States Army Research Institute of Environmental Medicine trials

Trials by the same sponsor.

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Data sources for this page

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