This study was aimed to assess effect of sesame on lipid profile, blood pressure, oxidative stress and inflammatory markers. A total of 50 patients with type 2 diabetes will be recruited. Inclusion criteria are: subjects between 18-60 years old; type 2 diabetic patients without insulin therapy; patients with history of diabetes more than one year; patients with body mass index between 18 to 35 kg/m2. Exclusion criteria are: pregnant or lactating women; smokers and alcohol consumers; patients consume antioxidant supplements (vitamin E and C, caroteniodes and coQ10); patients with cardiac, hepatic, respiratory and chronic renal diseases; patients with acute or chronic inflammation. Subjects will be randomly assigned into groups 1) sesame (intervention) and 2) usual breakfast (control) and will be followed up for 6 weeks. Lipid profile, blood pressure, oxidative stress and inflammatory markers will be measured at baseline and 6 weeks after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105161640N4
Registration date:2011-11-27, 1390/09/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-27, 1390/09/06
Registrant information
Name
Parvin Mirmiran
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Me
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2500
Email address
mirmiran@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
Obesity Research Center, Research Institute for Endocrine Science, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of sesame (Sesamum indicum) effects on some biochemical parameters in type 2 diabetic patients
Public title
Evaluation of sesame (Sesamum indicum) effects on some biochemical parameters in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: subjects between 18-60 years old; type 2 diabetic pateints without insulin therapy; pateints with history of diabetes more than one year; pateints with body mass index between 18 to 35 kg/m2. Exclusion criteria: pregnant or lactating women; smokers and alcohol sonsumers; pateints cosume antioxidant supplements (vitamin E and C, caroteniodes and coQ10); pateints with cardiac, hepatic, respiratory and chronic renal diseases; pateints with acute or chronic inflammation
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Street address
No 24, Parvaneh st., Yemen Blvd., Chamran exp.
City
Tehran
Postal code
Approval date
2011-08-02, 1390/05/11
Ethics committee reference number
349EC
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Lipid profile
Timepoint
Baseline and 6 weeks after intervention
Method of measurement
Biochemistery analysis
2
Description
Blood pressure
Timepoint
Baseline and 6 weeks after intervention
Method of measurement
Monometer
3
Description
Oxidative stress
Timepoint
Baseline and 6 weeks after intervention
Method of measurement
Biochemical analysis
4
Description
Inflammatory markers
Timepoint
Baseline and 6 weeks after intervention
Method of measurement
Biochemical analysis
Secondary outcomes
empty
Intervention groups
1
Description
Tahini (sesame)- 2 table spoon with bread in breakfast for 6 weeks
Category
Treatment - Other
2
Description
2 slices bread with cheese in breakfast for 6 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes clinice of Talaghani Hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Iran Diabetes Association
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute for Endocrine Science, Shaheed Beheshti University of Medical Sciences
Full name of responsible person
parvin mirmiran
Street address
No.24, Parvaneh St, Yemen Blvd, Chamran highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Endocrine Science, Shaheed Beheshti 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
Obesity Research Center, Research Institue for Endocrine Science, Shaheed Beheshti University of Med
Full name of responsible person
Parvin Mirmiran
Position
Director of Nutrition Unit of Obesity Research Center/ PhD in Nutrition
Other areas of specialty/work
Street address
No.24, Parvaneh St, Yemen Blvd, Chamran Exp
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
mirmiran@endocrine.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Obesity Research Center, Research Institue for Endocrine Science, Shaheed Beheshti University of Med
Full name of responsible person
Parvin Mirmiran
Position
PhD in Nutrition
Other areas of specialty/work
Street address
No.24, Parvaneh St, Yemen Blvd, Chamran Exp
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
mirmiran@endocrine.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Science, Shahid Beheshti University of Med
Full name of responsible person
Zahra Bahadoran
Position
MSc in Nutrition
Other areas of specialty/work
Street address
No.24, Parvaneh St, Yemen Blvd, Chamran Exp
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)