Objectives: Probiotics are defined as live microorganisms possess antioxidant and anti-inflammatory activity. This study is designed the effect of probiotic yogurt on oxidative stress and inflammatory markers in young women athletes after exhaustive exercise. Design: 30 healthy female students will be selected in both groups (15 controls and 15 experiments) at age 30-18 years. 500 ml probiotic yogurt and 500 ml ordinary yogurt will be taken to control and experiment groups for two weeks, respectively. Setting and Conduct: Fasting blood samples are taken for both groups at the beginning and end of the supplementation. Exhaustive exercise session will be given to both groups at the 15th day. Fasting blood samples are taken at the end of exhaustive exercise. Blood samples will be used to test of biochemical and inflammatory factors. Participants including major eligibility criteria: Young healthy males with moderate physical activity in 18-30 years old. Exclusion criteria for participant selection, including: Individuals with diseases; smoking; alcoholism and other supplements consumption; having certain dietary; professional training; sedentary and having 25 and less than18.5 kg.m2. Interventions: Probiotic yogurt and exhaustive exercise. Variables: Superoxide dismutase, Glutathione peroxidase, Malondialdehyde, Interlukine-6, Tumor necrosis factor-alpha, hs-CRP, Catalase, Matrix metalloproteinase-2 and 6.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307105144N4
Registration date:2014-02-20, 1392/12/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-20, 1392/12/01
Registrant information
Name
Ali Nemati
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 0052
Email address
a.nemati@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Ardabil University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-04-19, 1393/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic yogurt intake in the prevention of oxidative stress and inflammatory factors in young females after exhaustive exercise.
Public title
The effect of probiotic yogurt intake in the prevention of oxidative stress and inflammatory factors in young females after exhaustive exercise.
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: Young healthy females with moderate physical activity in 18-30 years old.
Exclusion criteria: Individuals with any diseases; smoking; alcoholism and other supplements consumption; having certain dietary; professional training; sedentary and having BMI over 25 and less than18.5 kg.m2.
Age
From 18 years old to 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Ardabil University of Medical Sciences
Street address
Ethic Committee of Ardabil University of Medical Sciences, Vice Chancellor for Research, Ardabil University of Medical Sciences, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran
City
Ardabil
Postal code
5318985991
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
arums 1018
Health conditions studied
1
Description of health condition studied
Young healthy females
ICD-10 code
Z02.5
ICD-10 code description
Examination for participation in sport
Primary outcomes
1
Description
Exhaustive exercise time
Timepoint
At the end of exercise
Method of measurement
With signs and symptoms of exhaustion
Secondary outcomes
1
Description
Weight
Timepoint
At the beginning of intervention
Method of measurement
Digital scales
2
Description
Height
Timepoint
At the beginning of intervention
Method of measurement
Stadiometers
3
Description
Malondialdehyde
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry
4
Description
Catalase
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry
5
Description
Total antioxidant capacity
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry
6
Description
Superoxide dismutase
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry
7
Description
Glutathione peroxidase
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry
8
Description
Matrix metalloproteinase-2
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA
9
Description
Interlukine-6
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA
10
Description
Tumor necrosis factor-alpha
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA
11
Description
hs-CRP
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Immunoturbidimetry
12
Description
Paraoxonase-1
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry
13
Description
Arylesterase
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry
14
Description
HDL-cholesterol
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry
15
Description
LDL-cholesterol
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry
16
Description
Triglyceride
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry
17
Description
Hemoglobin
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry
18
Description
Total cholesterol
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry
19
Description
Copper
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Atomic absorptions spectrophotometry
20
Description
Zinc
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Atomic absorptions spectrophotometry
21
Description
Magnesium
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Atomic absorptions spectrophotometry
22
Description
Ceruloplasmin
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry
23
Description
Ascorbic acid
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
Spectrophotometry
24
Description
Matrix metalloproteinase-9
Timepoint
At the beginning of intervention, previous and after of exercise
Method of measurement
ELISA
Intervention groups
1
Description
Given 500 ml/day probiotic yogurt for 14 days and once exhaustive exercise for intervention group.
Category
Other
2
Description
Given 500 ml/day ordinary yogurt for 14 days and once exhaustive exercise for control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil University of Medical Sciences
Full name of responsible person
Kobra Heydari
Street address
Biochemistry Dept, Ardabil University of Medical Sciences, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran.
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Ardabil University of Medical Sciences
Full name of responsible person
Hadi Peeri
Street address
Vice Chancellor for Research Ardabil University of Medical Sciences, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran.
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research Ardabil University of Medical Sciences
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
Ardabil University of Medical Sciences
Full name of responsible person
Kobra Heydari
Position
Student of MSc
Other areas of specialty/work
Street address
Biochemistry Dept, Ardabil University of Medical Sciences, Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran.
City
Ardabil
Postal code
5155653466
Phone
+98 44 1383 1568
Fax
+98 45 1551 3776
Email
k.heydari1977@yahoo.com
Web page address
http//:www.arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mohammad Mazani
Position
PhD of Clinical Biochemistry
Other areas of specialty/work
Street address
Biochemistry Dept, Faculty of Medicine, University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran
City
Ardabil
Postal code
5618953141
Phone
+98 45 1551 2788
Fax
+98 45 1551 3776
Email
m.mazani@arums.ac.ir
Web page address
http//:www.arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mohammad Mazani
Position
PhD of Clinical Biochemistry
Other areas of specialty/work
Street address
Biochemistry Dept, Faculty of Medicine, University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran
City
Ardabil
Postal code
5618953141
Phone
+98 45 1551 2788
Fax
+98 45 1551 3776
Email
m.mazani@arums.ac.ir
Web page address
http//:www.arums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)