ISRCTN ISRCTN93275136
DOI https://doi.org/10.1186/ISRCTN93275136
Submission date
17/09/2024
Registration date
19/09/2024
Last edited
19/09/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
The study aims to determine how soldiers feed and hydrate themselves before, during and after a military operation. Optimal nutrition and hydration status will support physical performance, while dehydration can lead to a loss of endurance capacity and hyperthermia.

Who can participate?
Male military paratroopers aged between 20 and 30 years, participating in a military operation of 1 week in rough conditions

What does the study involve?
1. Assessing body fat mass and body muscle mass with a BodyScan (Tanita MC780) every morning for 7 days
2. Assessing urine density with a refractometer every morning for 7 days
3. Assessing energy expenditure and sleep with an accelerometer for 7 days

What are the possible benefits and risks of participating?
The results will be used to develop recommendations to optimize the physical performance and living conditions of military personnel during military operations. Individual results will be discussed with the participants.

Where is the study run from?
Belgian Defence

When is the study starting and how long is it expected to run for?
July 2018 to December 2024

Who is funding the study?
Belgian Defence

Who is the main contact?
Prof. Dr Patrick Mullie, Patrick.mullie@mil.be

Contact information

Prof Patrick Mullie
Public, Scientific, Principal Investigator

Eversestraat 1
Evere
1140
Belgium

ORCiD logoORCID ID 0000-0001-5592-3169
Phone +32 (0)475809478
Email patrick.mullie@mil.be

Study information

Study designSingle-centre observational cross-sectional study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Workplace
Study typeQuality of life
Participant information sheet Not available in web format
Scientific titleEnergy availability, hydration and nutrition in army men during field training
Study acronymENAV
Study objectivesThe study aims to determine how soldiers feed and hydrate themselves before, during and after a military operation. Optimal nutrition and hydration status will support physical performance, while dehydration can lead to a loss of endurance capacity and hyperthermia. The selected population consists of military personnel during military operations.

Participants will be required to complete the following steps:
1. Assessing anthropometric data with a BodyScan (Tanita MC780)
2. Assessing urine density with a refractometer
3. Assessing energy expenditure and sleep with an accelerometer
Ethics approval(s)

Approved 11/07/2018, Ethics Committee VUB Brussels (Laarbeeklaan 101, Brussels, 1050, Belgium; +32 (0)24775584; commissie.ethiek@uzbrussel.be), ref: B.U.N. 143201836602

Health condition(s) or problem(s) studiedNutrition and dehydration during military operations
InterventionIt is an observational study, so there is no intervention. The researchers plan to do three assessments, i.e., BodyScan with a Tanita to assess body composition, assess daily urine density and assess energy expenditure with an accelerometer-type actigraph. This will be done during 1 week, with no further follow-up. This data will help make recommendations for military men during exercises and operations.
Intervention typeOther
Primary outcome measure1. Relative and absolute body fat mass and body muscle mass (kg-percent) measured with impedance, i.e., with an MC780 Tanita Body Scale, every morning for 1 week
2. Density of morning urine measured with an Atago refractometer every morning for 1 week
3. Energy expenditure in kcal.d-1 measured with an accelerometer continuously for 7 days
4. Sleep duration in min.d-1 measured with an accelerometer continuously for 7 days
5. Sleep disruption measured with the sleep fragmentation index (SFI) and an accelerometer continuously for 7 days
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/07/2018
Completion date03/12/2024

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit20 Years
Upper age limit30 Years
SexMale
Target number of participants30
Key inclusion criteria1. Male
2. Aged between 20 and 30 years
3. Military personnel
4. During a military operation in Hungary
Key exclusion criteria1. Female
2. Aged above 30 years
Date of first enrolment23/11/2024
Date of final enrolment23/11/2024

Locations

Countries of recruitment

  • Belgium

Study participating centre

3 Para
Kaliebaan 30
Tielen
2460
Belgium

Sponsor information

Belgian Defence
Government

Eversestraat 1
Evere
1140
Belgium

Phone +32 (0)87 59 41 11
Email CTCN@mil.be
Website https://www.mil.be/

Funders

Funder type

Government

Belgian Defence

No information available

Results and Publications

Intention to publish date01/01/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planInternal anonymous report
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from Prof. Patrick Mullie (patrick.mullie@mil.be)

Editorial Notes

18/09/2024: Study's existence confirmed by Ethics Committee VUB Brussels.