The aim of this randomized clinical trial is to determine the effects of sesame seed consumption on metabolic syndrome components, serum level of Angiotensin II and Adiponectin in women with metabolic syndrome. Fifty patients aged between 30 to 65 years old are assigned randomly into two groups. All participants have healthy diet during 6-weeks duration of study. Subjects in intervention group consume 50 gram sesame seed powder for 6 weeks. Anthropometric and blood pressure measurements, 3 day 24h dietary recalls and fasting blood samples are collected at the beginning and at the end of study. Fasting blood sugar, lipid profile, Angiotensin II and Adiponectin are measured. The participants are asked not to change their medicine and activity during the study and refrain from sesame and their products while on the study
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014051814680N2
Registration date:2014-06-10, 1393/03/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-10, 1393/03/20
Registrant information
Name
Farideh Shishehbor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8430
Email address
shishehbor-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Joundishapour University of Medical Science
Expected recruitment start date
2014-02-15, 1392/11/26
Expected recruitment end date
2014-03-11, 1392/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sesame seeds consumption on metabolic syndrome components, serum level of Angiotensin II and Adiponectin in women with metabolic syndrome
Public title
Effect of sesame on metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: adult woman over 30 years old, subjects having 3 or more of the criteria for diagnosis of metabolic syndrome (waist circumference 80cm and more, triglycerides 150 mg/dl and more, High Density Lipoprotein Cholesterol 50mg/dl and more, fasting blood sugar 100 mg/dl and more , blood pressure 130/85mmHg and more.Exclusion criteria: history of alcohol abuse and drug dependence; hormonal therapy; acute or chronic inflammatory; history of cancer; use of multivitamin-mineral and antioxidant supplements 6 months prior to the study; a restrictive diet or weight change 5 kg and more during 3 months prior to study; pregnancy and lactating; and sesame allergy.
Age
From 30 years old to 65 years old
Gender
Female
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Joundishapour University of Medical Science
Street address
Ahvaz Joundishapour University of Medical Science
City
ahvaz
Postal code
Approval date
2014-02-24, 1392/12/05
Ethics committee reference number
NRC-9214
Health conditions studied
1
Description of health condition studied
Metabolic Syndrome
ICD-10 code
E88
ICD-10 code description
Other metabolic disorders
Primary outcomes
1
Description
Systolic and diastolic blood pressure
Timepoint
baseline and after 6 weeks
Method of measurement
Aneroid sphygmomanometer
2
Description
Fasting blood sugar
Timepoint
baseline and after 6 weeks
Method of measurement
Spectrophotometry
3
Description
Total Cholesterol
Timepoint
baseline and after 6 weeks
Method of measurement
Spectrophotometry
4
Description
Triglyceride
Timepoint
baseline and after 6 weeks
Method of measurement
Spectrophotometry
5
Description
Low Density Lipoprotein Cholesterol
Timepoint
baseline and after 6 weeks
Method of measurement
Friedewald Formula
6
Description
High Density Lipoprotein Cholesterol
Timepoint
baseline and after 6 weeks
Method of measurement
Spectrophotometry
7
Description
Waist circumference
Timepoint
baseline and after 6 weeks
Method of measurement
Midway between the lower rib margin and the iliac crest
8
Description
Angiotensin II
Timepoint
baseline and after 6 weeks
Method of measurement
ELIZA
9
Description
Adiponectin
Timepoint
baseline and after 6 weeks
Method of measurement
ELIZA
Secondary outcomes
1
Description
Dietary Factors
Timepoint
during duration of study
Method of measurement
3-day 24h dietary recalls
2
Description
Body Mass Index
Timepoint
Baseline and after 6 weeks
Method of measurement
Formula
3
Description
Insuline
Timepoint
Baseline and after 6 weeks
Method of measurement
ELIZA
Intervention groups
1
Description
Intervention Group: having healthy diet and daily 50 g sesame seed powder consumption for 6 weeks
Category
Lifestyle
2
Description
Control Group: having healthy diet
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Street address
golestan Avn
City
ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Ahvaz Joundishapour University of Medical Science
Full name of responsible person
Dr Farideh Shishehbor
Street address
Ahvaz Joundishapour University of Medical Science
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 of Ahvaz Joundishapour University of Medical Science
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
Para medicine Faculty, Ahvaz Joundishapour University of Medical Science
Full name of responsible person
Negar Hojati
Position
MSc Student of Nutrition Science
Other areas of specialty/work
Street address
Ahvaz Joundishapour University of Medical Science
City
Ahvaz
Postal code
Phone
+98 61 1373 8319
Fax
Email
negar_hojati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Joundishapour University of Medical Science
Full name of responsible person
Negar Hojati
Position
MSc Student of Nutrition Science
Other areas of specialty/work
Street address
Ahvaz Joundishapour University of Medical Science
City
Ahvaz
Postal code
Phone
+98 61 1373 8319
Fax
Email
negar_hojati@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Joundishapour University of Medical Science
Full name of responsible person
Negar Hojati
Position
MSc Student of Nutrition Science
Other areas of specialty/work
Street address
Ahvaz Joundishapour University of Medical Science
City
Ahwaz
Postal code
Phone
+98 61 1373 8319
Fax
Email
negar_hojati@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)