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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Body Weight

Intervention / Treatment
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* Dietary Supplement: Control
* Dietary Supplement: Protein
* Dietary Supplement: Carbohydrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Military Training, Whey Protein, Body Composition