Aim: The aim of this study is compare the effects of probiotic supplementation on the changes levels of lymphocytes(LY) and monocytes(MO), granulocytes (GR)and CRP, IgA serum of male athletes before and after exhaustive exercise.
Methods: In a double-blind placebo-controlled study، 16 male volunteers aged between 19-25 years were assigned into two groups probiotic (n=8) and placebo (n=8).
Inclusion Criteria were being healthy male , without history of CHD diseses. Also exclusion criteria including consumption of diary, affected to sport injury, abling to do sport test.
Subjects consumed 2 capsules probiotic /day or 2 capsules placebo /day for 30 days. The fasting blood samples were collected at the beginning of the study and the end of 30 days before and after exhaustive exercise(Bruce test). Lymphocytes، monocytes, granulocytes, IgA and CRP in serum were analyzed.
General information
Acronym
Effect of probiotic supplement on immune system response in male Athlete
IRCT registration information
IRCT registration number:IRCT2013122115883N1
Registration date:2014-01-27, 1392/11/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-27, 1392/11/07
Registrant information
Name
Marzieh Aghaei
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3665 6917
Email address
dr.ambeigi@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
None
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic supplement on immune system response in male Athlete
Public title
Effect of probiotic supplement on immune system response in male Athlete
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Being athletic; being healthy male ; without history of CHD diseses
Exclusion Criteria: Consumption of diary; affected to sport injury; ablity on donig sport test.
Age
From 19 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Commitee of Alzahra University
Street address
Faculty of Sport, Deh Vanak, Tehran
City
Tehran
Postal code
Approval date
2011-05-16, 1390/02/26
Ethics committee reference number
486/12/90-د
Health conditions studied
1
Description of health condition studied
Immunity system
ICD-10 code
D80.2
ICD-10 code description
Selective deficiency of immunoglobulin A [IgA]
Primary outcomes
1
Description
Lymphosite
Timepoint
After one month
Method of measurement
CBC
Secondary outcomes
1
Description
IGA
Timepoint
After one month
Method of measurement
CBC Test
Intervention groups
1
Description
2 probiotic capsules per day for 30 days (60 capsules ) with 2 milion microorganism per each capsules
Category
Prevention
2
Description
60 placebo capsule contain carbohydrate for 30 days (2 per day) assigned to control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Sport Science
Full name of responsible person
Marzieh Aghaei
Street address
Hazrate Masoumeh Hospital, Qom
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Marzieh Aghaei
Full name of responsible person
Marzieh Aghaei
Street address
Hazrate Masoumeh Hospital- Qom
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Marzieh Aghaei
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qom Univ Med Sci
Full name of responsible person
Marzieh Aghaei
Position
MSc
Other areas of specialty/work
Street address
Taghavi, 45 metri Modares
City
Qom
Postal code
Phone
+253 6656917
Fax
Email
marzieh.aghaei@yahoo.comdr.ambeigi@muq.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Marzieh Aghaei
Position
MSC
Other areas of specialty/work
Street address
TAghavi 3- 45 Metri Modares
City
Qom
Postal code
Phone
+253 6656917
Fax
Email
marzieh.aghaei@yahoo.comdr.ambeigi@muq.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Marzieh Aghaei
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)