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

NCT ID: NCT02327208

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-02-28

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.

Conditions

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Body Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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).

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

Protein

Consume 4 whey protein-based snack-bars in addition to 3 combat rations each day during training.

Group Type ACTIVE_COMPARATOR

Protein

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate

Consume 4 carbohydrate-based snack-bars in addition to 3 combat rations each day during training.

Group Type ACTIVE_COMPARATOR

Carbohydrate

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Control

Intervention Type DIETARY_SUPPLEMENT

Protein

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Placebo (Rations Only) Protein Bar Granola Bar

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Army Research Institute of Environmental Medicine

FED

Sponsor Role lead

Responsible Party

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Stefan Pasiakos

Nutritional Physiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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US Army Research Institute of Environmental Medicine

Natick, Massachusetts, United States

Site Status

Norwegian Defense Research Establishment

Kjeller, , Norway

Site Status

Skjold Garrison

Skjold, , Norway

Site Status

Countries

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United States Norway

References

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Karl JP, Margolis LM, Madslien EH, Murphy NE, Castellani JW, Gundersen Y, Hoke AV, Levangie MW, Kumar R, Chakraborty N, Gautam A, Hammamieh R, Martini S, Montain SJ, Pasiakos SM. Changes in intestinal microbiota composition and metabolism coincide with increased intestinal permeability in young adults under prolonged physiological stress. Am J Physiol Gastrointest Liver Physiol. 2017 Jun 1;312(6):G559-G571. doi: 10.1152/ajpgi.00066.2017. Epub 2017 Mar 23.

Reference Type BACKGROUND
PMID: 28336545 (View on PubMed)

Margolis LM, Murphy NE, Martini S, Gundersen Y, Castellani JW, Karl JP, Carrigan CT, Teien HK, Madslien EH, Montain SJ, Pasiakos SM. Effects of Supplemental Energy on Protein Balance during 4-d Arctic Military Training. Med Sci Sports Exerc. 2016 Aug;48(8):1604-12. doi: 10.1249/MSS.0000000000000944.

Reference Type RESULT
PMID: 27054679 (View on PubMed)

Pasiakos SM, Margolis LM, Murphy NE, McClung HL, Martini S, Gundersen Y, Castellani JW, Karl JP, Teien HK, Madslien EH, Stenberg PH, Young AJ, Montain SJ, McClung JP. Effects of exercise mode, energy, and macronutrient interventions on inflammation during military training. Physiol Rep. 2016 Jun;4(11):e12820. doi: 10.14814/phy2.12820.

Reference Type RESULT
PMID: 27273884 (View on PubMed)

Other Identifiers

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14-33HC

Identifier Type: -

Identifier Source: org_study_id

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