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Effect of antioxidant rich formula supplementation and aerobic training on glutathione peroxidase and superoxide dismutase activity, determination of HSP-70 expressing mRNA and oxidative stress in female athletes

Protocol summary

Summary
Objectives: The aim of this study is to investigate the effect of antioxidant rich formula supplementation and aerobic training on glutathione peroxidase and superoxide dismutase activity, determination of HSP-70 expressing mRNA and oxidative stress in female athletes. Design: This study is a double blind study. Setting, conduct and intervention: Volunteers will randomly assigned to two groups (antioxidant rich formula/semi-formula). Weight, height, body fat percent and dietary intake (3-day food record questionnaire) will be assessed. The first blood sampling will be held before the exercise test (Astrand test), and the second and third blood sampling will be held 1 and 24 hours after the test, respectively. After 4 weeks intervention (supplements and aerobic exercise), the blood sampling (3 times) will be held as mentioned previously. Participants including major eligibility criteria: Twenty four female athletes (aged 20-30 years) will participate in the study. The participants should have no muscular, inflammatory and cardiovascular disease and have not used any dietary or vitamin supplements 8 weeks prior to the study. Main outcome measures (variables): MDA, TAC, SOD and GPx activity, HSP-70 expressing mRNA will be assessed. In addition CK and LDH (indicator of muscular damage), leucocyte count and WBC (indicator of inflammation) and FBS (indicator of glucose intolerance), Hb and Hct (indicator of blood concentration) will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016030526909N1
Registration date: 2016-04-10, 1395/01/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-04-10, 1395/01/22
Registrant information
Name
Sevana Daneghian
Name of organization / entity
Ahvaz Jundishapour university
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 7080
Email address
daneghian.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of antioxidant rich formula supplementation and aerobic training on glutathione peroxidase and superoxide dismutase activity, determination of HSP-70 expressing mRNA and oxidative stress in female athletes
Public title
Antioxidants in athletes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: 20-30 years old recreational healthy female athletes; without cardiovascular disease and muscular damage; and have normal blood pressure. Exclusion criteria: Weight loss or any special diet such as vegetarian diet over the past three month; consumption of any sport supplements such as creatine, Amino acids or protein or vitamin and mineral supplements and anti-inflammatory drugs 8 weeks prior the study; having acute and chronic illnesses; high fasting blood sugar or abnormal lipid profile; anemia; hormonal disorders and a BMI less than 18.5 or above 24.9
Age
From 75 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
...
Secondary trial Id
...
Registration date
2017-11-21, 1396/08/30

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Khuozestan, Ahvaz, Ahvaz Jundishapur University of Medical Sciences, Ethics Committee Ahvaz
City
Ahvaz
Postal code
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.AJUMS.REC.1394.617

Health conditions studied

1

Description of health condition studied
General health of athletes
ICD-10 code
Z10.3
ICD-10 code description
Routine general health check-up of sports teams

Primary outcomes

1

Description
Total antioxidant capacity (TAC)
Timepoint
6 times: 3 times before the intervention (before, 1 hour and 24 hours after exercise test) and 3 times post intervention (before, 1 hour and 24 hours after exercise test)
Method of measurement
Specific kit

2

Description
malondialdehyde (MDA)
Timepoint
6 times: 3 times before the intervention (before, 1 hour and 24 hours after exercise test) and 3 times post intervention (before, 1 hour and 24 hours after exercise test)
Method of measurement
Specific kit

3

Description
Super oxide dismutase (SOD) activity
Timepoint
6 times: 3 times before the intervention (before, 1 hour and 24 hours after exercise test) and 3 times post intervention (before, 1 hour and 24 hours after exercise test)
Method of measurement
Specific kit

4

Description
Glutathione peroxidase (GPx) activity
Timepoint
6 times: 3 times before the intervention (before, 1 hour and 24 hours after exercise test) and 3 times post intervention (before, 1 hour and 24 hours after exercise test)
Method of measurement
Specific kit

5

Description
HSP-70 expressing mRNA
Timepoint
6 times: 3 times before the intervention (before, 1 hour and 24 hours after exercise test) and 3 times post intervention (before, 1 hour and 24 hours after exercise test)
Method of measurement
Specific kit

Secondary outcomes

empty

Intervention groups

1

Description
Antioxidant rich formula made of local materials
Category
Other

2

Description
Semi formula with similar appearance
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
University sport hall
Full name of responsible person
Marina Daneghian, PhD candidate of physical education
Street address
Pasdaran highway, Islamic Azad University of Tabriz, physical education building
City
Tabriz

2

Recruitment center
Name of recruitment center
Tabriz SAMA vocational school
Full name of responsible person
Marina Daneghian, PhD candidate of physical education
Street address
Elgoli road, stop Khayyam, 35 M Sinai, not far from the towers Tabriz sky
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Mostafa Feghhi
Street address
Vice chancellor for research, Ahvaz Jundishapur University of Medical Science,Golestan Ave, Ahvaz,Khouzestan Ahvaz
City
Ahvaz
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, Ahvaz Jundishapour 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
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Sevana Daneghian
Position
Phd Candidate of Nutrition Science
Other areas of specialty/work
Street address
Dept of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science,Golestan Ave, Ahvaz,Khouzestan
City
Ahvaz
Postal code
Phone
+98 61 3373 8330
Fax
Email
sevana_d@yahoo.com; daneghian.s@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Reza Amani
Position
Professor
Other areas of specialty/work
Street address
Dept of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science,Golestan Ave, Ahvaz,Khouzestan
City
Ahvaz
Postal code
Phone
+98 61 3373 8330
Fax
Email
rezaamani@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Sevana Daneghian
Position
Phd Candidate of Nutrition Science
Other areas of specialty/work
Street address
Dept of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science, Golestan Ave. Ahvaz, Khuozestan
City
Ahvaz
Postal code
Phone
00
Fax
Email
sevana_d@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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