Designing a pragmatic operational diet with specific features that will improve performance and provide adequate energy and reduce fatigue and stress in military personnel in combat operations.
Design
Phase 1) Formulation Design
Phase II) Safety and Quality
Phase III) Clinical trial: A pilot study and clinical trial will be conducted. Individuals with age range of 18 to 50 years old will be included in the study, randomly divided into 3 groups of 15 people: the first group received the intervention, receiving ration with the pragmatic compounds, and the second and third groups of the control group receiving respectively ration without of pragmatic compounds and traditional used rations with the same calorie content.
Food rations will be distributed to target groups within a 10 day training period. Before and after the intervention, physical fitness indexes, serum levels of Hsp72, total antioxidant capacity, oxidant index, inflammatory factor, blood lactate, venous blood gases, appetite and physical activity measurements through a pedometer will be recorded.
Settings and conduct
Food rations will be distributed to target populations during an operational military training course for target groups over a 10-day operation. Diets will be consumed in the form of compressed food in three meals, each with a weight of 140 grams and 700 kilocalories of energy per serving.
Participants/Inclusion and exclusion criteria
Army military personnel are in the camp during a hard military training period.
Intervention groups
Group 1: intervention group, Receive Compact Food ration with pragmatic and beneficial compounds
Group 2: Control group, Receive Compact Food ration without pragmatic compounds
Group 3: control group, traditional rations used in operational areas with the same amount of calories.
Main outcome variables
Evaluation of functional and fatigue indices by physical fitness and exams
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181014041336N1
Registration date:2019-01-15, 1397/10/25
Registration timing:registered_while_recruiting
Last update:2019-01-15, 1397/10/25
Update count:0
Registration date
2019-01-15, 1397/10/25
Registrant information
Name
Vahid hadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2417
Email address
hadiv941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and evaluation of humanitarian ration formulations in crisis with emphasis on functional capacity and oxidative stress levels.
Public title
The effect of pragmatic rations on the performance of military personnel with intense activity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Military personnel are maneuvering operations
Age range 18-50 years
Do not use antioxidant and herbal supplements at least 1 month before starting the study
Willingness to cooperate and sign a conscientious consent form after full knowledge of the goals and method of the study
Exclusion criteria:
Special Diet for at least 6 months
History of any allergies and allergies to certain compounds
smoking
Use of any antioxidant and anti-inflammatory nutritional supplement during the study
Unwillingness to participate in the study or continue cooperation
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were randomly selected using randomized block method and RAS software was divided into 3 groups of 15, the first group received intervention, receiving diet with functional and extractive compounds, and the second and third groups of control, respectively, receiving the ration of pragmatic and usual diet Used in operational areas with the same amount of calories.
Blinding (investigator's opinion)
Double blinded
Blinding description
Stratified block randomization
Placebo
Used
Assignment
Parallel
Other design features
Our goal is to formulate a diet with military application, treatment and use in crisis and review it in the form of a clinical trial.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2018-10-24, 1397/08/02
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.276
Health conditions studied
1
Description of health condition studied
Military personnel in operational maneuvers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Total antioxidant capacity
Timepoint
At baseline and after 10 day of intervention
Method of measurement
blood sample
2
Description
Malondialdehyde
Timepoint
At baseline and after 10 day of intervention
Method of measurement
Spectrophotometry
3
Description
High-sensitivity C-reactive protein
Timepoint
At baseline and after 10 day of intervention
Method of measurement
Immunoturbidimetry
Secondary outcomes
1
Description
maximum rate of oxygen consumption (vo2max)
Timepoint
At baseline and after 10 day of intervention
Method of measurement
step test
Intervention groups
1
Description
Intervention group: Receive Compact Food ration with pragmatic and beneficial compounds for 10 days
Category
Other
2
Description
Control group: Receive Compact Food ration without pragmatic and beneficial compounds for 10 days
Category
Other
3
Description
Control group: traditional rations used in operational areas for 10 days
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Army of the Islamic Republic of Iran
Full name of responsible person
Vahid Hadi
Street address
Army University of Medical Sciences- Shahid Etemadzadeh -West Fatemi St.-Tehran
City
Tehran
Province
Tehran
Postal code
9137913316
Phone
+98 21 4382 2284
Email
vahidhadi1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 1882 3255
Fax
+98 51 1882 3251
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Abdolreza Norouzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Faculty of Medicine, Mashhad University of Medical Sciences, Paradise Daneshgah, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48564
Phone
+98 51 3882 7033
Fax
+98 51 3800 2421
Email
Norouzya@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Abdolreza Norouzi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Faculty of Medicine, Mashhad University of Medical Sciences, Paradise Daneshgah, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7033
Fax
+98 51 3800 2421
Email
Norouzya@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Hadi
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Faculty of Medicine, Mashhad University of Medical Sciences, Paradise Daneshgah, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7033
Email
Hadiv941@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles.
When the data will become available and for how long
The non-identifiable individual participant data will become available after the publication of the relevant articles.
To whom data/document is available
The non-identifiable individual participant data will become available to other researchers in academic institutions.
Under which criteria data/document could be used
The non-identifiable individual participant data can only be used for research.
From where data/document is obtainable
The non-identifiable individual participant data will be obtainable by sending an e-mail to Dr. Abdul Reza norouzy. ( Norouzya@mums.ac.ir)
What processes are involved for a request to access data/document
Other researchers in academic institutions can send their request to Dr. Abdul Reza Norouzy.