Main goal : Survey of effect of bread with Nigella sativa on Lipid Profiles, Apolipoproteins, Inflammatory Factors and Coagulatory Factors in Metabolic Syndrome paitents.
Inclusion criteria :Having at least 3 items of 5 items of Metabolic Syndrome. Exclusion criteria : Change in medical therapy,Pregnancy and Having chronic diseases .
Study population :persons(Male and Female) With Metabolic Syndrome in age range 20-65 years old
Sample size : 48 persons
Study intervention :Effects of bread with Nigella sativa on blood and clinical parameters
Type of study :The Participants enter in a cross over study as in phase 1,half of those (intervention group)consume dietetic bread with nigella sativa and the others(control group) consume regular dietetic bread daily for 2 months and after a washout period (15 days),groups position is exchanged and phase 2 continue for 2 month.
Time period :July - December 2015
Primary outcomes : Change in blood parameters
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015041821815N1
Registration date:2015-06-30, 1394/04/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-06-30, 1394/04/09
Registrant information
Name
Alireza Mohtashami
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2752
Email address
mohtashami_52@yahoo.com
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Bread With Nigella Sativa on Lipid Profiles, Apolipoproteins, Inflammatory Factors and Coagulatory Factors in Metabolic Syndrome Patients
Public title
Effect of Bread With Nigella Sativa on Blood Factors in Metabolic Syndrome Patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria :Having 3 Items of 5 Items of Metabolic Syndrome :Waist Circumference over 102 for Men and over 88 Centimeter for Women, Serum Triglycerid 150 mg/dl or More or Using of Drug , Serum HDL under 40 for Men and under 50 for Women, Fasting Blood Sugar 100 mg/dl or More or Using of Drug , Blood Presure 130/85 or More or Using of drug. Exclusion Criteria :Change in Type or Dosage of Drug or Supplements in Medical Therapy,Pregnancy,Having Chronic Diseases in Liver, kidney, Neural and musclelar system.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezargarib Street
City
Isfahan
Postal code
8174673461
Approval date
2014-11-16, 1393/08/25
Ethics committee reference number
393636
Health conditions studied
1
Description of health condition studied
Metabolic Syndrome
ICD-10 code
-
ICD-10 code description
-
2
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Obesity
Primary outcomes
1
Description
Blood Parameters
Timepoint
Before and After Intervention ( as Crossover Design )
Method of measurement
Evaluation of Blood Parameters with Lab Technics
Secondary outcomes
1
Description
Medical and Body Parameters (Blood Pressure, Weight, Waist Circumference)
Timepoint
Before and After Intervention (as Crossover Design)
Method of measurement
Measuring of Blood Pressure with Sphygmomanometer, Measuring of Waist Circumference with Meter, Measuring of Weight with Balance Divice
Intervention groups
1
Description
It is prepared for intervention group to use a 100 grams dietetic bread with nigella sativa(3 grams) and having a balanced diet with decreasing 10 percent in dietary energy for 2 months.
Category
Lifestyle
2
Description
It is prepared for control group to use a 100 grams dietetic bread and having a balanced diet with decreasing 10 percent in dietary energy for 2 months.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Medical Sciences, Azad University of Chalus
Full name of responsible person
Alireza Mohtashami
Street address
Azad University of Chalus, Hefdaheshahrivar Street, Chalus
City
Chalus
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mahdi Nematbakhsh
Street address
Isfahan University of Medical Sciences, Hezargarib Street
City
Isfahan
Grant name
اجرای برنامه های اموزشی
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Alireza Mohtashami
Position
Ph.D Candidate in Nutrition Sciences
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezargarib Street
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2752
Fax
+98 31 3668 2509
Email
mohtashami_52@yahoo.com
Web page address
www.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohammadhasan Entezari
Position
Ph.D
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezargarib Street
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2775
Fax
+98 31 3668 2509
Email
entezari@hlth.mui.ac.ir
Web page address
WWW.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Alireza Mohtashami
Position
ph.D Candidate in Nutrition Sciences
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezargarib Street
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2752
Fax
+98 31 3668 2509
Email
mohtashami_52@yahoo.com
Web page address
www.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)