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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stefan Pasiakos, United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier:
NCT02327208
First received: December 17, 2014
Last updated: July 19, 2017
Last verified: April 2015
  Purpose
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.

Condition Intervention
Body Weight Dietary Supplement: Control Dietary Supplement: Protein Dietary Supplement: Carbohydrate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Stefan Pasiakos, United States Army Research Institute of Environmental Medicine:

Primary Outcome Measures:
  • Protein Balance [ Time Frame: day 5 ]
    Whole-body nitrogen balance

  • Lean Body Mass [ Time Frame: day 5 ]
    Body composition

  • Skeletal Muscle Mass [ Time Frame: day 5 ]
    Isotopic estimates of muscle protein mass

  • Body weight [ Time Frame: day 5 ]

Secondary Outcome Measures:
  • Intestinal health [ Time Frame: day 5 ]
    Gut health

  • Thermal and Physiological Strain [ Time Frame: average 6 days ]
    Core and skin temperature, heart rate, respiration rate


Enrollment: 73
Study Start Date: January 2015
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Granola Bar

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02327208

Locations
United States, Massachusetts
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, United States, 01760
Norway
Norwegian Defense Research Establishment
Kjeller, Norway
Skjold Garrison
Skjold, Norway
Sponsors and Collaborators
United States Army Research Institute of Environmental Medicine
  More Information

Publications:
Responsible Party: Stefan Pasiakos, Nutritional Physiologist, United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier: NCT02327208     History of Changes
Other Study ID Numbers: 14-33HC
Study First Received: December 17, 2014
Last Updated: July 19, 2017

Keywords provided by Stefan Pasiakos, United States Army Research Institute of Environmental Medicine:
Military Training
Whey Protein
Body Composition

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 21, 2017