InflammationNCT03524690
Effects of Severe Negative Energy Balance on Inflammation
A study testing Energy Balance and Negative Energy Balance in people with Inflammation, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Energy Balance and Negative Energy Balance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2019to 8 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760
About this study
Official title: Effects of Severe Negative Energy Balance on Inflammation During a Simulated Military Operation
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.
Read the 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.
- Conditions
- Inflammation
- Being tested
- Energy Balance, Negative Energy Balance
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy BalanceDietary supplement
Energy Balance Sufficient food provided to maintain energy balance.
Negative Energy BalanceDietary supplement
Negative Energy Balance Insufficient food provided to maintain energy balance resulting in negative energy balance.
| Study group | Role | What they receive |
|---|---|---|
| SUSOPS Balance | Active comparator | Volunteers provided sufficient food to maintain energy balance. Receives: Dietary Supplement: Energy Balance |
| SUSOPS Negative Balance | Experimental | Volunteers provided insufficient food to maintain energy balance resulting in negative energy balance. Receives: Dietary Supplement: Negative Energy Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of a simulated military operation on systemic inflammation
Assessed using blood assays.
Measured: 6 hour measure
Secondary outcomes (1)
The effects of energy balance and severe energy deficit on inflammation during a simulated military operation
Assessed using mineral absorption from stable isotopes.
Measured: 6 hour measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start13 Feb 2019
- Primary completion8 Oct 2019
- Study completion8 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, cross-over controlled trial
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Stefan M Pasiakos, PhD, Principal investigator, Military Nutrition Division, USARIEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524690
- Sponsor's protocol ID
- 18-06HC
- Status last verified
- Apr 2020
- First submitted
- 2 May 2018
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33184627
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Severe Negative Energy Balance on Inflammation During a Simulated Military Operation
- ClinicalTrials.gov ID
- NCT03524690
- Acronym / sponsor ID
- 18-06HC
- Conditions
- Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 8 Oct 2019 (actual)
- Study completion
- 8 Oct 2019 (actual)
- First posted
- 15 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, cross-over controlled trial
| Arm | Type | Receives |
|---|---|---|
| SUSOPS Balance | Active comparator | Dietary Supplement: Energy BalanceVolunteers provided sufficient food to maintain energy balance. |
| SUSOPS Negative Balance | Experimental | Dietary Supplement: Negative Energy BalanceVolunteers provided insufficient food to maintain energy balance resulting in negative energy balance. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy BalanceEnergy Balance Sufficient food provided to maintain energy balance. | Dietary supplement | SUSOPS Balance |
| Negative Energy BalanceNegative Energy Balance Insufficient food provided to maintain energy balance resulting in negative energy balance. | Dietary supplement | SUSOPS Negative Balance |
Primary outcome
The effects of a simulated military operation on systemic inflammation
Time frame: 6 hour measure
Assessed using blood assays.
1 secondary outcome
The effects of energy balance and severe energy deficit on inflammation during a simulated military operation
Time frame: 6 hour measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Derived from this study: PubMed 33184627Hennigar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan M Pasiakos, PhD principal investigator
Military Nutrition Division, USARIEM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy Balance and Negative Energy Balance in people with Inflammation, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of a simulated military operation on systemic inflammation (time frame: 6 hour measure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03524690, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020; AzTrials last refreshed its copy on 7 Nov 2026.