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

U

United States Army Research Institute of Environmental Medicine

Status

Completed

Conditions

Body Weight

Treatments

Dietary Supplement: Control
Dietary Supplement: Protein
Dietary Supplement: Carbohydrate

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02327208
14-33HC

Details and patient eligibility

About

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.

Full 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.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

73 participants in 3 patient groups, including a placebo group

Control
Placebo Comparator group
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).
Treatment:
Dietary Supplement: Control
Protein
Active Comparator group
Description:
Consume 4 whey protein-based snack-bars in addition to 3 combat rations each day during training.
Treatment:
Dietary Supplement: Protein
Carbohydrate
Active Comparator group
Description:
Consume 4 carbohydrate-based snack-bars in addition to 3 combat rations each day during training.
Treatment:
Dietary Supplement: Carbohydrate

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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