The purpose of this study is to compare the effect of daily intake of breads containing flaxseed or sesame powder on the blood pressure of individuals with stage I hypertension. This is a randomized, single centered, and single blinded study. Researchers and analyzers are not aware of the type of bread that is used by patients. Eligible subjects will be selected from the patients attending the Yazd Cardiovascular Research Center. Main inclusion criteria are ages between 30 to 65 years, and having stage I hypertension. Pregnant and diabetic patients or individuals suffering from severe systemic or intestinal diseases will be excluded. Total sample size is 84 with at least 42 patients in each group. Groups A and B will receive daily breads containing 30 grams of either flaxseed or sesame powder, respectively. Study will be started on May 21st of 2016 and will last for 14 weeks. Measured outcomes are changes in systolic and diastolic blood pressure. After initial blood taking, patients will be instructed to get their weekly breads from a collaborative store. To be sure that breads are used properly, patients will be contacted either face to face or by phone and ask about how they are taking their breads and how many are left. Systolic and diastolic blood pressure will be measured at the beginning, middle and at the end of the study. Eating habits and physical activities will also be asked at these times.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016050327729N1
Registration date:2016-05-23, 1395/03/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-23, 1395/03/03
Registrant information
Name
Moneyreh Modares Mosadegh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
modares@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-09-05, 1395/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of breads containing flaxseed and sesame on the blood pressure of patients with stage I hypertension
Public title
Comparison of breads containing flaxseed and sesame on the blood pressure of patients with mild to moderate hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 30 to 65 years; stage I hypertension (Systolic Blood Pressure (SBP) 140-159 mmHg, Diastolic Blood Pressure (DBP) 90-99 mmHg) using prevailed treatment; using a particular anti-hypertensive therapy for at least 3 months and Exclusion Criteria: pregnant women or women planning to get pregnant; being allergic to sesame or flaxseed; suffering from intestinal diseases such as Crohn's disease, colitis, peptic ulcer, irritable bowel syndrome (IBS), and other severe systemic diseases like systemic lupus erythematosus (SLE), cancer, or stage IV respiratory diseases; history of myocardial infarction; coronary bypass surgery during last 6 months; stage II hypertension; diabetic patients; routinely using nonsteroidal anti-inflammatory drugs (NSAID's); change of antihypertensive drugs during the study
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
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
Ethical Committee of Medical School Of Shahid Sadoughi University of Medical sciences
Street address
Third floor, Centeral Building, Bahonar Square
City
Yazd
Postal code
Approval date
2016-03-14, 1394/12/24
Ethics committee reference number
IR.SSU.MEDICINE.REC.1394.492
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
systolic blood pressure
Timepoint
prior to study, Seventh week, and at the end of study
Method of measurement
in mmHg using mercuric manometer
2
Description
Diastolic blood pressure
Timepoint
prior to study, Seventh week, and at the end of study
Method of measurement
in mmHg using mercuric manometer
Secondary outcomes
1
Description
Body Mass Index (BMI)
Timepoint
prior to study, Seventh week, and at the end of study
Method of measurement
kg/m^2 ; it is calculated measuring weight in kilogram and height in meter
Intervention groups
1
Description
Patients in group A will receive 30 grams of powdered flaxseed by using 90 gram bread daily
Category
Treatment - Other
2
Description
Patients in group B will receive 30 grams of powdered sesame by using 90 gram bread daily
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Cardiovascular Research Center
Full name of responsible person
Dr. Hadiani
Street address
Afshar hospital, Jomhuri Islami Blvd.
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology of Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Mehrparvar
Street address
Third floor, Centeral Building, Bahonar Square
City
Yazd
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 and Technology of Shahid Sadoughi University of Medical Sciences