NCT02327208

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 21, 2017

Status Verified

April 1, 2015

Enrollment Period

1 month

First QC Date

December 17, 2014

Last Update Submit

July 19, 2017

Conditions

Body Weight

Keywords

Military TrainingWhey ProteinBody Composition

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Intestinal health

    day 5

  • Thermal and Physiological Strain

    average 6 days

Study Arms (3)

Control

PLACEBO COMPARATOR

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

Protein

ACTIVE COMPARATOR

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

Dietary Supplement: Protein

Carbohydrate

ACTIVE COMPARATOR

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

Dietary Supplement: Carbohydrate

Interventions

ControlDIETARY_SUPPLEMENT
Also known as: Placebo (Rations Only)
Control
ProteinDIETARY_SUPPLEMENT
Also known as: Protein Bar
Protein
CarbohydrateDIETARY_SUPPLEMENT
Also known as: Granola Bar
Carbohydrate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female Norwegian Soldiers aged 18 years or older participating in the 4-day training program.

You may not qualify if:

  • History of skin irritation (e.g., nickel or adhesive allergy), difficulty swallowing large pills, and allergies to dairy products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

US Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

Location

Norwegian Defense Research Establishment

Kjeller, Norway

Location

Skjold Garrison

Skjold, Norway

Location

Related Publications (3)

  • 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.

    PMID: 28336545BACKGROUND

  • 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.

    PMID: 27054679RESULT

  • 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.

    PMID: 27273884RESULT

MeSH Terms

Conditions

Body Weight

Interventions

ProteinsCarbohydrates

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nutritional Physiologist

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 30, 2014

Study Start

January 1, 2015

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

July 21, 2017

Record last verified: 2015-04

Locations

US(1)NO(2)