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

Not Applicable

Completed

• Conditions: Body Weight
• Interventions: Dietary Supplement: Carbohydrate; Dietary Supplement: Protein; Dietary Supplement: Control

• Registration Number: NCT02327208
• Lead Sponsor: United States Army Research Institute of Environmental Medicine

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.

Study Timeline

• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-30
• Study Start: 2015-01
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2017-07-19
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbohydrate	Carbohydrate	Consume 4 carbohydrate-based snack-bars in addition to 3 combat rations each day during training.
Protein	Protein	Consume 4 whey protein-based snack-bars in addition to 3 combat rations each day during training.
Control	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).

Primary Outcome Measures

Name	Time	Method
Protein Balance	day 5	Whole-body nitrogen balance
Body weight	day 5
Lean Body Mass	day 5	Body composition
Skeletal Muscle Mass	day 5	Isotopic estimates of muscle protein mass

Secondary Outcome Measures

Name	Time	Method
Intestinal health	day 5	Gut health
Thermal and Physiological Strain	average 6 days	Core and skin temperature, heart rate, respiration rate

Trial Locations

Locations (3)

US Army Research Institute of Environmental Medicine; 🇺🇸 Natick, Massachusetts, United States

Norwegian Defense Research Establishment; 🇳🇴 Kjeller, Norway

Skjold Garrison; 🇳🇴 Skjold, Norway