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Effects of Severe Negative Energy Balance on Inflammation

Primary Purpose

Inflammation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Energy Balance

Negative Energy Balance

About this trial

This is an interventional basic science trial for Inflammation

Eligibility Criteria

18 Years - 39 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

US Army Research Institute of Environmental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SUSOPS Balance

SUSOPS Negative Balance

Arm Description

Volunteers provided sufficient food to maintain energy balance.

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

Outcomes

Primary Outcome Measures

The effects of a simulated military operation on systemic inflammation

Assessed using blood assays.

Secondary Outcome Measures

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

Assessed using mineral absorption from stable isotopes.

Full Information

NCT ID

NCT03524690

First Posted

May 2, 2018

Last Updated

April 20, 2020

Sponsor

United States Army Research Institute of Environmental Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03524690

Brief Title

Effects of Severe Negative Energy Balance on Inflammation

Official Title

Effects of Severe Negative Energy Balance on Inflammation During a Simulated Military Operation

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

February 13, 2019 (Actual)

Primary Completion Date

October 8, 2019 (Actual)

Study Completion Date

October 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

United States Army Research Institute of Environmental Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Endurance exercise elicits skeletal muscle and systemic inflammation. Inflammation in response to endurance exercise is normally attenuated with adequate rest and recovery as skeletal muscle adapts with training. However, performing repeated bouts of prolonged and unaccustomed, muscle damaging (i.e., eccentric loading) endurance exercise may be detrimental to performance and limit the adaptive responses to exercise by diminishing the absorption of key nutrients. Warfighters are commonly exposed to such exercise bouts during sustained training and combat operations, the effects of which may be exacerbated by negative energy balance. Therefore, to define the putative role of energy balance on systemic inflammation, we will conduct a controlled laboratory study that simulates the physiological stressors imposed during sustained military training and combat operations to determine if systemic inflammation is exacerbated by underfeeding. Twenty-six male, non-obese (body mass index 19.9-29.9 kg/m2), physically active adults will be recruited to participate in a 32 d, longitudinal study. The study is comprised of four sequential phases: 1) a 96 h testing period, 2) a 7 day recovery period (Recovery 1), 3) a second, 96 h testing period, and 4) a 14 d recovery period (Recovery 2). During testing, subjects will be randomized to consume either sufficient food (combat rations) to maintain energy balance or will be provided a restricted amount of food to elicit severe negative energy balance. Mineral absorption studies and will be conducted during each testing condition, energy balance and energy negative balance. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Randomized, cross-over controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SUSOPS Balance

Arm Type

Active Comparator

Arm Description

Volunteers provided sufficient food to maintain energy balance.

Arm Title

SUSOPS Negative Balance

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Energy Balance

Intervention Description

Energy Balance Sufficient food provided to maintain energy balance.

Intervention Type

Dietary Supplement

Intervention Name(s)

Negative Energy Balance

Intervention Description

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

Primary Outcome Measure Information:

Title

The effects of a simulated military operation on systemic inflammation

Description

Assessed using blood assays.

Time Frame

6 hour measure

Secondary Outcome Measure Information:

Title

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

Description

Assessed using mineral absorption from stable isotopes.

Time Frame

6 hour measure

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefan M Pasiakos, PhD

Organizational Affiliation

Military Nutrition Division, USARIEM

Official's Role

Principal Investigator

Facility Information:

Facility Name

US Army Research Institute of Environmental Medicine

City

Natick

State/Province

Massachusetts

ZIP/Postal Code

01760

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33184627

Citation

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.

Results Reference

derived

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Effects of Severe Negative Energy Balance on Inflammation

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