Determination of the Effect of Probiotic Supplementation on Physical Performance, Sleep Quality and Student's attitudes of Imam Ali (AF) University Students at Army Army
Design
Clinical trial with community-based and pragmatic control group, with parallel, double-blind, randomized.
Settings and conduct
The project is conducted on 150 students of Imam Ali Army officer university with the aim of examining the effect of probiotic supplementation on physical performance, mood and quality of sleep in this university. These 150 sampled individuals are randomly divided into two groups of 75 Which is administered bilaterally to a probiotic supplement and to another placebo group, so that the sample population and the researchers are not aware of the complementary nature of each group.
Participants/Inclusion and exclusion criteria
Students at Imam Ali University Army, Entry criteria: 1. Male students aged 18 to 26 years
2. Students who do not have any injuries or physical illnesses.
3. The all students is in a course and they must be in the same military training and receive the same nutrition.
Non-compliance criteria and exclusion criteria:
1. Those who are not Consent with the use of probiotics or placebo
2. Students who have been injured during the course of military exercises
3. Researchers diagnosed with probiotic susceptibility.
4. Scientists who are medically exempt from combat.
Intervention groups
Intervention group: Includes 30 students,that each students taking one probiotic capsule of 500 mg per day for 8 weeks, 30 minute after lunch.( the capsules made in zist takhmir company)
Intervention group: Includes 30 students,that each students taking one plasebo capsule of 500 mg per day for 8 weeks, 30 minute after lunch.( the capsules made in zist takhmir company)
Main outcome variables
physical performance, mood and quality of sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180201038585N4
Registration date:2019-07-11, 1398/04/20
Registration timing:retrospective
Last update:2019-07-11, 1398/04/20
Update count:0
Registration date
2019-07-11, 1398/04/20
Registrant information
Name
Karim Parastouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 3516
Email address
parastouei@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-05, 1397/12/14
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Probiotics supplementation and placebo Effect on Physical Performance, Mood and Sleep Quality in Military Students
Public title
The effect of probiotic supplementation on physical performance , sleep quality and mood
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Male students 18 to 26 years old
Students who have no visible physical illness or injury
The whole of the students will be from one period and will be under the same military training and will benefit from the same nutrition.
Exclusion criteria:
Students who are not satisfied with the use of probiotics or placebo
Students injured during the course of military exercises
Students diagnosed as having probiotic susceptibility
Students who are physically unable to work
Age
From 18 years old to 26 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization to group intervention and control
A stratified randomized permuted block (with block size 4) will generated by an independent bio-statistician. Subjects will stratified according to gender and age. Random assignment will done by the use of table of random numbers. The enrolling participants, and assigning participants to the groups will carried out by a trained nutritionist. Researchers will not informed about randomization process until completion of data analyses (concealme
Blinding (investigator's opinion)
Double blinded
Blinding description
All probiotics and its placebo powders will be provided by Zisttakhmir company in pre-packed boxes and will be numbered for each patient according to the randomization sequence. probiotic and its placebos will be in the same form of package and the patients and researcher will not aware of the content of the pack until the end of the trial.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of bahgeyatlah University of Medical Sciences
Street address
Sheykh bahaei Ave, Molasadra Ave
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2019-01-21, 1397/11/01
Ethics committee reference number
IR.BMSU.REC.1397.133
Health conditions studied
1
Description of health condition studied
physical performance, mood and sleep quality
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Physical performance
Timepoint
One day Before and one day after Supplementation
Method of measurement
Sport test (runing 1600 m , runing 4×9m , Barfix , sit-ups) and cooper test
2
Description
Mood
Timepoint
One day Before and one day after Supplementation
Method of measurement
Brums questionnaires
3
Description
Sleep quality
Timepoint
One day Before and one day after Supplementation
Method of measurement
PSQI questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Probiotics, one gram, zist takhmir company
Category
Treatment - Drugs
2
Description
Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam ali Army university
Full name of responsible person
Jalil Najafi
Street address
Imam khomeyni Ave
City
Tehran
Province
Tehran
Postal code
1317893471
Phone
+98 21 6695 5041
Email
najafiharsin65@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Baqiatolah Uni
Street address
sheykh bahaei Ave , Molasadra Ave
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2341
Fax
+98 21 8248 2343
Email
research@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Sheykh bahaei Ave , Molasadra Ave
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2341
Email
parastoei@bmsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
karim parastouei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Sheykh Bahaei Ave, Molasadra Ave
City
tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3264
Email
parastouei@bmsu.ac.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
karim parastouei
Position
asistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Sheykh bahaei Ave, Molasdra Ave
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3264
Email
parastouei@bmsu.ac.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available