Protocol summary

Summary
This study is clinical trial to determine effect of tomato juice on concentration of antioxidant enzymes and total antioxidant capacity of blood in over-weight and obese female. In this study 80 female with BMI>27 and Inclusion criteria divided into intervention and control groups with40 people Randomly.Participants for a period of twenty days daily, respectively, will receive 500 ml of tomato juice and water. For all participants after determine the body mass index, food records was 24 hours (two working days and a holiday) and food frequency questionnaire to assess dietary habits can be filled. Then bled and targeted intervention is performed. At the end of intervention is re-sampling. Determine The blood concentrations of antioxidant enzymes (superoxid dismutas, catalase, glutathione peroxidase) and total antioxidant capacity of blood, measured at the beginning and end of the study are compared. Thus the effect of tomato juice consumption on antioxidant enzymes and total antioxidant capacity of blood concentrations in overweight and obese women will be determined

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012062610114N1
Registration date: 2012-07-23, 1391/05/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-07-23, 1391/05/02
Registrant information
Name
Dr.Soltanali Mahboob
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 2292
Email address
mahbooba@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Center of Nutrition Research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-07-01, 1391/04/11
Expected recruitment end date
2012-10-02, 1391/07/11
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of tomato juice on concentration of antioxidant enzymes and total antioxidant capacity of blood in over-weight and obese female student
Public title
The effect of tomato juice on concentration of antioxidant enzymes and total antioxidant capacity of blood in over-weight and obese female student
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: female student with overweight or obese (BMI> 27 kg/m2) at age 20 to 30; absence of inflammatory diseases such as diabetes, cardiovascular disease, multiple sclerosis, rheumatoid arthritis, cancer , inflammatory diseases, gastrointestinal and respiratory (eg asthma, allergies) and hypertension; non-smoking; not taking any special medication (especially anti-inflammatory drugs like aspirin); lack of vitamin and mineral supplements and tend to daily consumption of tomato juice. Exclusion criteria: not regular daily consumption of tomato juice and fail using recommended daily consumption size.
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
St. Tabriz, Attar Street Golgasht
City
Tabrize
Postal code
Approval date
2012-05-21, 1391/03/01
Ethics committee reference number
9136

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Determine of blood antioxidant enzymes (superoxide dismutase, catalase, Glvtatyvnpraksydaz) in both groups
Timepoint
Beginning and end of intervention in both groups
Method of measurement
Spectrophotometry and ELISA

Secondary outcomes

1

Description
Determination of total caoacity antioxidant of blood
Timepoint
Beginning and end of intervention in both groups
Method of measurement
Spectrophotometry and ELISA

Intervention groups

1

Description
Daily consumption of 500 ml of tomato juice 20 days at the Intervention group
Category
Prevention

2

Description
Daily consumption of 500 ml of water 20 days at the Control group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University and their dormitories
Full name of responsible person
Zohreh pourahmadi
Street address
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Center of Nutrition Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. AR ostadrahimi
Street address
St. Tabriz, Attar Street Golgasht Health and Nutrition Building,Center of Nutritional Science Research
City
Tabrize
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Center of Nutrition Research, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Soltanali Mahboob
Position
PhD Nutrition / Executive
Other areas of specialty/work
Street address
St. Attar, St. Golgasht, Tabriz University of Medical Sciences, Health and Nutrition Building
City
Tabriz
Postal code
Phone
+98 41 1334 1113
Fax
Email
Dr_mahboob@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical , Health and Nutrition Building
Full name of responsible person
Dr.Soltanali Mahboob
Position
PhD Nutrition / Executive
Other areas of specialty/work
Street address
St. Attar, St. Golgasht, Tabriz University of Medical Sciences, Health and Nutrition Building
City
Tabriz
Postal code
Phone
+98 41 1333 4078
Fax
Email
Dr_mahboob@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical , Health and Nutrition Building
Full name of responsible person
Zohreh pourahmadi
Position
MS.student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
St. Attar, St. Golgasht, Tabriz University of Medical Sciences, Health and Nutrition Building
City
Tabriz
Postal code
Phone
0
Fax
Email
pourahmadiz@yahoo.com
Web page address

Sharing plan

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