Lean Body Mass Response to Higher-protein Diets During Winter Military Training
Primary Purpose
Body Weight
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Control
Protein
Carbohydrate
Sponsored by
About this trial
This is an interventional basic science trial for Body Weight focused on measuring Military Training, Whey Protein, Body Composition
Eligibility Criteria
Inclusion Criteria:
- Male and female Norwegian Soldiers aged 18 years or older participating in the 4-day training program.
Exclusion Criteria:
- History of skin irritation (e.g., nickel or adhesive allergy), difficulty swallowing large pills, and allergies to dairy products
Sites / Locations
- US Army Research Institute of Environmental Medicine
- Norwegian Defense Research Establishment
- Skjold Garrison
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Control
Protein
Carbohydrate
Arm Description
3 Combat rations only per day. No additional experimental food items (those assigned to the active comparator groups will consume isoenergetic carbohydrate and protein-based food products).
Consume 4 whey protein-based snack-bars in addition to 3 combat rations each day during training.
Consume 4 carbohydrate-based snack-bars in addition to 3 combat rations each day during training.
Outcomes
Primary Outcome Measures
Protein Balance
Whole-body nitrogen balance
Lean Body Mass
Body composition
Skeletal Muscle Mass
Isotopic estimates of muscle protein mass
Body weight
Secondary Outcome Measures
Intestinal health
Gut health
Thermal and Physiological Strain
Core and skin temperature, heart rate, respiration rate
Full Information
NCT ID
NCT02327208
First Posted
December 17, 2014
Last Updated
July 19, 2017
Sponsor
United States Army Research Institute of Environmental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02327208
Brief Title
Lean Body Mass Response to Higher-protein Diets During Winter Military Training
Official Title
Effects of Carbohydrate and Protein Supplementation on Whole-body Protein Balance and Skeletal Muscle Mass During Winter Military Training: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Army Research Institute of Environmental Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objectives of this study are to: 1) determine effects of a prototype recovery food product providing supplemental energy on whole-body protein balance, skeletal muscle mass, and biomarkers of physiological status and strain during winter military training, and 2) determine the extent to which varying macronutrient composition (protein-based [PRO] versus carbohydrate-based [CHO]) of the food product modulates the physiological consequences to strenuous military training.
Detailed Description
Up to 120 Norwegian Soldiers from the 2nd Battalion, Brigade North, Norwegian Army stationed at Skjold Garrison will be enrolled in a 9-day, randomized controlled study. Using dietary analysis, body composition assessments, stable isotope methodologies, basic biochemical techniques, and measures of physiological strain, the effects of supplemental energy in the form of carbohydrate and protein on indices of muscle mass and physiological status will be assessed.
We hypothesize that consuming supplemental energy will attenuate the effects of severe energy deficit on inflammation, androgenic hormones, and whole-body protein retention, thereby protecting skeletal muscle mass. We expect that consuming PRO will promote a more favorable recovery than consuming CHO, as indicated by measures of increased whole-body protein synthesis and greater conservation of skeletal muscle mass.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight
Keywords
Military Training, Whey Protein, Body Composition
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
3 Combat rations only per day. No additional experimental food items (those assigned to the active comparator groups will consume isoenergetic carbohydrate and protein-based food products).
Arm Title
Protein
Arm Type
Active Comparator
Arm Description
Consume 4 whey protein-based snack-bars in addition to 3 combat rations each day during training.
Arm Title
Carbohydrate
Arm Type
Active Comparator
Arm Description
Consume 4 carbohydrate-based snack-bars in addition to 3 combat rations each day during training.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Other Intervention Name(s)
Placebo (Rations Only)
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein
Other Intervention Name(s)
Protein Bar
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate
Other Intervention Name(s)
Granola Bar
Primary Outcome Measure Information:
Title
Protein Balance
Description
Whole-body nitrogen balance
Time Frame
day 5
Title
Lean Body Mass
Description
Body composition
Time Frame
day 5
Title
Skeletal Muscle Mass
Description
Isotopic estimates of muscle protein mass
Time Frame
day 5
Title
Body weight
Time Frame
day 5
Secondary Outcome Measure Information:
Title
Intestinal health
Description
Gut health
Time Frame
day 5
Title
Thermal and Physiological Strain
Description
Core and skin temperature, heart rate, respiration rate
Time Frame
average 6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female Norwegian Soldiers aged 18 years or older participating in the 4-day training program.
Exclusion Criteria:
History of skin irritation (e.g., nickel or adhesive allergy), difficulty swallowing large pills, and allergies to dairy products
Facility Information:
Facility Name
US Army Research Institute of Environmental Medicine
City
Natick
State/Province
Massachusetts
ZIP/Postal Code
01760
Country
United States
Facility Name
Norwegian Defense Research Establishment
City
Kjeller
Country
Norway
Facility Name
Skjold Garrison
City
Skjold
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
28336545
Citation
Karl JP, Margolis LM, Madslien EH, Murphy NE, Castellani JW, Gundersen Y, Hoke AV, Levangie MW, Kumar R, Chakraborty N, Gautam A, Hammamieh R, Martini S, Montain SJ, Pasiakos SM. Changes in intestinal microbiota composition and metabolism coincide with increased intestinal permeability in young adults under prolonged physiological stress. Am J Physiol Gastrointest Liver Physiol. 2017 Jun 1;312(6):G559-G571. doi: 10.1152/ajpgi.00066.2017. Epub 2017 Mar 23.
Results Reference
background
PubMed Identifier
27054679
Citation
Margolis LM, Murphy NE, Martini S, Gundersen Y, Castellani JW, Karl JP, Carrigan CT, Teien HK, Madslien EH, Montain SJ, Pasiakos SM. Effects of Supplemental Energy on Protein Balance during 4-d Arctic Military Training. Med Sci Sports Exerc. 2016 Aug;48(8):1604-12. doi: 10.1249/MSS.0000000000000944.
Results Reference
result
PubMed Identifier
27273884
Citation
Pasiakos SM, Margolis LM, Murphy NE, McClung HL, Martini S, Gundersen Y, Castellani JW, Karl JP, Teien HK, Madslien EH, Stenberg PH, Young AJ, Montain SJ, McClung JP. Effects of exercise mode, energy, and macronutrient interventions on inflammation during military training. Physiol Rep. 2016 Jun;4(11):e12820. doi: 10.14814/phy2.12820.
Results Reference
result
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Lean Body Mass Response to Higher-protein Diets During Winter Military Training
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