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Effects of Severe Negative Energy Balance on Inflammation

NCT03524690 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-04-22

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Energy Balance

Energy Balance Sufficient food provided to maintain energy balance.

DIETARY_SUPPLEMENT

Negative Energy Balance

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

Sponsors & Collaborators

  • United States Army Research Institute of Environmental Medicine

    lead FED

Principal Investigators

  • Stefan M Pasiakos, PhD · Military Nutrition Division, USARIEM

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-13
Primary Completion
2019-10-08
Completion
2019-10-08

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03524690 on ClinicalTrials.gov