Effects of Severe Negative Energy Balance on Inflammation
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|ClinicalTrials.gov Identifier: NCT03524690|
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : February 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Inflammation||Dietary Supplement: Energy Balance Dietary Supplement: Negative Energy Balance||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Randomized, cross-over controlled trial|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Severe Negative Energy Balance on Inflammation During a Simulated Military Operation|
|Actual Study Start Date :||February 13, 2019|
|Estimated Primary Completion Date :||May 30, 2019|
|Estimated Study Completion Date :||December 30, 2020|
Active Comparator: SUSOPS Balance
Volunteers provided sufficient food to maintain energy balance.
Dietary Supplement: Energy Balance
Energy Balance Sufficient food provided to maintain energy balance.
Experimental: SUSOPS Negative Balance
Volunteers provided insufficient food to maintain energy balance resulting in negative energy balance.
Dietary Supplement: Negative Energy Balance
Negative Energy Balance Insufficient food provided to maintain energy balance resulting in negative energy balance.
- The effects of a simulated military operation on systemic inflammation [ Time Frame: 6 hour measure ]Assessed using blood assays.
- The effects of energy balance and severe energy deficit on inflammation during a simulated military operation [ Time Frame: 6 hour measure ]Assessed using mineral absorption from stable isotopes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524690
|Contact: Military Nutrition Division, USARIEMfirstname.lastname@example.org|
|Contact: Adrienne M Hatch, MSemail@example.com|
|United States, Massachusetts|
|US Army Research Institute of Environmental Medicine||Recruiting|
|Natick, Massachusetts, United States, 01760|
|Contact: Stefan M Pasiakos, PhD 508-233-6474 firstname.lastname@example.org|
|Contact: Adrienne Hatch, MS 508-233-5648 email@example.com|
|Principal Investigator:||Stefan M Pasiakos, PhD||Military Nutrition Division, USARIEM|