Comparison of the effects of probiotic supplementation and omega 3 on total antioxidant capacity in children and adolescents exposed to air pollutants: A randomized, double-blind, placebo-controlled trial
Evaluation the effect of probiotic supplementation on total antioxidant capacity in healthy children and adolescents exposed to air pollution in Isfahan, Iran
Design
This study is a randomized, parallel, placebo-controlled, double-blind clinical trial. Participants will be allocated to treatment and omega3 groups by permuted block randomization with size of four. All participants and researchers will be blind to the treatment groups until the statistical analysis will be completed
Settings and conduct
The mean values of the 24-hour air quality index (AQI) in Isfahan city that register during the week before the day of blood sampling will be recorded. Among the air pollution measurement stations, one station will be selected randomly. From the schools located near that station, two of them are selected, and then 100 students who are eligible for the study will be invited to participate by random selection.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to participate in the study; healthy subject without any chronic disease, physiological disorders and endocrine diseases. Non-inclusion criteria: using antioxidant supplements other than supplements in this study; gastrointestinal problems; sensitivity to the supplements; taking any antioxidant supplements or probiotic products during the last month
Intervention groups
The intervention group will receive one probiotic supplement capsule called FamiLact (zist takhmir company, Tehran, Iran). Control group will receive 1000 mg omega 3 capsule daily.
Main outcome variables
Total antioxidant capacity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081105001434N12
Registration date:2020-04-21, 1399/02/02
Registration timing:prospective
Last update:2020-04-21, 1399/02/02
Update count:0
Registration date
2020-04-21, 1399/02/02
Registrant information
Name
Roya Kelishadi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 3060
Email address
kelishadi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of probiotic supplementation and omega 3 on total antioxidant capacity in children and adolescents exposed to air pollutants: A randomized, double-blind, placebo-controlled trial
Public title
Effect of probiotic supplementation on total antioxidant capacities
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the studys
subjects who live in pollutant areas
Healthy subject without any chronic disease, physiological disorders and endocrine disease
Exclusion criteria:
use of antioxidant supplements other than supplements selected during the study
Gastrointestinal problems
Sensitivity to the supplement under the study
Taking any antioxidant supplements or probiotic products in the past month
Age
From 10 years old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method is used. Unit of randomization is individual. A random number table is used. The drugs are labeled A and B, and each person is randomly assigned to each group
Blinding (investigator's opinion)
Double blinded
Blinding description
Because this is a double-blind study, neither the participants nor the experimenters know who is consuming the drug and who is consuming the placebo. Subjects in both groups will be recruited on different days and will not see each other and will not understand the difference between drugs and the type of supplements that they use. The person who will give the supplements to the participants is not the researcher of the study. Also, all the supplements will be put in the same packaging and with the same label.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Isfahan University of Medical Sciences
Street address
Vice chancellor for research and technology; No 4 building; Isfahan University of Medical Sciences and Health Services; Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-03-05, 1398/12/15
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.791
Health conditions studied
1
Description of health condition studied
healthy subject exposed to air pollution
ICD-10 code
Z77.110
ICD-10 code description
Contact with and (suspected) exposure to air pollution
Primary outcomes
1
Description
Total antioxidant capacity
Timepoint
Before intervention and after intervention
Method of measurement
ELISA Kit
Secondary outcomes
1
Description
Height
Timepoint
before the intervention and after the intervention
Method of measurement
Meter
2
Description
Weight
Timepoint
before the intervention and after the intervention
Method of measurement
Scale
3
Description
Waist circumference
Timepoint
before the intervention and after the intervention
Method of measurement
Meter
4
Description
Body Mass Index
Timepoint
before the intervention and after the interventi
Method of measurement
weight (Kg)/ Squared meters
Intervention groups
1
Description
Intervention group: 1 FamiLact capsule (zist takhmir company, Tehran, Iran) will be consumed daily for 8 weeks . FamiLact ® is a synbiotic (probiotic + prebiotic) formulation and contains high amounts of 9 safe and beneficial bacterial strains plus fructooligosaccharides as prebiotic. Strains and prebiotic used include the following: • Lactobacillus rhamnosus• Lactobacillus casei• Lactobacillus bulgaricus• Lactobacillus acidophilus• Bifidobacterium breve• Bifidobacterium longum • Streptococcus thermophilus
Category
Prevention
2
Description
Control group will receive 1000 mg omega 3 capsule daily for 8 weeks
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Roya Kelishadi
Street address
Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8163946711
Phone
+98 31 3792 5281
Email
roya.kelishadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Roya Kelishadi
Street address
Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8163946711
Phone
+98 31 3792 5281
Email
roya.kelishadi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Roya Kelishadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8163946711
Phone
+98 31 3792 5281
Fax
Email
roya.kelishadi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Roya Kelishadi, MD
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8163946711
Phone
+98 31 3792 5281
Fax
Email
roya.kelishadi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Roya Kelishadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8163946711
Phone
+98 31 3792 5281
Fax
+98 31 1668 7898
Email
roya.kelishadi@gmail.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some part of the data, such as information about the main outcome can be shared
When the data will become available and for how long
2021
To whom data/document is available
Researchers in academic and scientific institutions
Under which criteria data/document could be used
Researchers in academic and scientific institutions when they need the data for meta-analysis study
From where data/document is obtainable
Send email to
roya.kelishadi@gmail.com
What processes are involved for a request to access data/document
The applicant can request data and information from the corresponding person after providing a reason for having the data and how to use them