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Completed

NCT Number: NCT02327208

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian Defense Research Establishment, Kjeller, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Dietary Supplement

Other names: Placebo (Rations Only)

Protein

Dietary Supplement

Other names: Protein Bar

Carbohydrate

Dietary Supplement

Other names: Granola Bar

Primary outcomes

  1. Protein Balance

    Time frame: day 5

    Whole-body nitrogen balance

  2. Lean Body Mass

    Time frame: day 5

    Body composition

  3. Skeletal Muscle Mass

    Time frame: day 5

    Isotopic estimates of muscle protein mass

  4. Body weight

    Time frame: day 5

Secondary outcomes

  1. Intestinal health

    Time frame: day 5

    Gut health

  2. Thermal and Physiological Strain

    Time frame: average 6 days

    Core and skin temperature, heart rate, respiration rate

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 30, 2014
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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