Lean Body Mass Response to Higher-protein Diets During Winter Military Training

Effects of Carbohydrate and Protein Supplementation on Whole-body Protein Balance and Skeletal Muscle Mass During Winter Military Training: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Body Weight
• Intervention / Treatment: Dietary supplement: Control; Dietary supplement: Protein; Dietary supplement: Carbohydrate

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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Kjeller, Norway
    • Norwegian Defense Research Establishment
  • Skjold, Norway
    • Skjold Garrison
• United States
  • Massachusetts
    • Natick, Massachusetts, United States, 01760
      • US Army Research Institute of Environmental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; 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).	Dietary supplement: Control; Other Names: Placebo (Rations Only)
Active Comparator: Protein; Consume 4 whey protein-based snack-bars in addition to 3 combat rations each day during training.	Dietary supplement: Protein; Other Names: Protein Bar
Active Comparator: Carbohydrate; Consume 4 carbohydrate-based snack-bars in addition to 3 combat rations each day during training.	Dietary supplement: Carbohydrate; Other Names: Granola Bar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein Balance	Whole-body nitrogen balance	day 5
Lean Body Mass	Body composition	day 5
Skeletal Muscle Mass	Isotopic estimates of muscle protein mass	day 5
Body weight		day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal health	Gut health	day 5
Thermal and Physiological Strain	Core and skin temperature, heart rate, respiration rate	average 6 days

Collaborators and Investigators

• Sponsor: United States Army Research Institute of Environmental Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: December 17, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (Estimate): December 30, 2014

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Body Composition; Military Training; Whey Protein
• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: 14-33HC