Protocol summary

Summary
This study is a double blind clinical trial on 80 patients with hypertension and dyslipidemia. The study process can be summarized in three steps: 1) the preparation of flaxseed powder and placebo in sachet form by Kamvar company, Isfahan, Iran. Participants will consume either 36 gram flaxseed sachet or 12 gram placebo sachet per day during study. 2) At first, form referring patients to affiliated clinics with Isfahan university of medical sciences, 80 patients with dyslipidemia and high blood pressure will be selected based on inclusion criteria by a cardiologist and after that will be recruited to this study . After taking informed written consent, patients will randomly be assigned to either intervention group (36 gram flaxseed sachet per day) or placebo group (12 gram sachet placebo per day ) for 8 week. Biochemical assessment including lipid profiles (TG, LDL-C, HDL-C, Total-C), C-reactive protein, fasting blood sugar, anthropometric indices (weight, height, waist circumference, hip circumference, waist to hip ratio), systolic and diastolic blood pressure and physical activity will be measured at the beginning and end of study. 3-day dietary record will be obtained from all participants at week 0, 4 and 8. 3) Data will be analyzed by using SPSS software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016081611763N28
Registration date: 2017-06-30, 1396/04/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-30, 1396/04/09
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-04-04, 1396/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of flaxseed powder consumption on lipid profile, hypertention and C-Reactive Protein in dyslipidemic and hypertensive pasients
Public title
Flaxseed powder and cardiovascular risk factor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Triglyceride concentrations more than 150; Total cholesterol levels more than 200; LDL-C levels more than 130; HDL-C levels less than 40 mg per dl; blood pressure equal to or more than 140/90 mmHg. Exclusion criteria: Pregnancy ; Breast-feeding; being on a diet during the last three month; renal disease; cancer; Fasting blood sugar more than 110; infection and inflammatory diseases
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezarjarib street.Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2015-12-21, 1394/09/30
Ethics committee reference number
IR.MUI.REC.1394.3.1051

Health conditions studied

1

Description of health condition studied
Hypertention
ICD-10 code
I10
ICD-10 code description
فشار خون بالا پرفشاری خون (شریانی) (خوش خیم) (ضروری) (بدخیم) (اولیه) (سیستمیک)

2

Description of health condition studied
Dyslipidemia
ICD-10 code
E78.1
ICD-10 code description
هیپرگلیسریدمی اندوژنیک

Primary outcomes

1

Description
Cholestrol
Timepoint
At the first and end of study
Method of measurement
laboratory

2

Description
HDL-C
Timepoint
At the first and end of study
Method of measurement
laboratory

3

Description
TG
Timepoint
AT THE FIRST AND THE END OF STUDY
Method of measurement
Laboratory measurements

4

Description
LDL-C
Timepoint
AT THE FIRST AND THE END OF STUDY
Method of measurement
Laboratory measurements

5

Description
blood pressure
Timepoint
first middle end of the study
Method of measurement
pressure indicator

6

Description
crp
Timepoint
first and end of the study
Method of measurement
Laboratory measurements

7

Description
weight
Timepoint
First,middle and the end of study
Method of measurement
scale

Secondary outcomes

empty

Intervention groups

1

Description
placebo: 12 gram sachet produced by Kamvar company, Isfahan
Category
Placebo

2

Description
intervention: 36 gram flaxseed sachet
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinics affiliated with University of Medical Sciences
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
School of Nutrition
Street address
Hezar jarib street
City
Isfahan
Grant name
Grant code / Reference number
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- School of Nutrition
Full name of responsible person
Naeme Haghighatsiar
Position
Masters student of nutrition
Other areas of specialty/work
Street address
Hezarjarib street.Isfahan University of Medical Sciences-Nutrition College
City
Isfahan
Postal code
Phone
+98 917 352 8587
Fax
Email
naeme.haghighat@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences- School of Nutrition
Full name of responsible person
Gholamreza Askari
Position
PHD
Other areas of specialty/work
Street address
Hezarjerib street.Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3668 8487
Fax
Email
ASKARI@MUI.AC.IR
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Naeme Haghighatsiar
Position
Masters student of nutrition
Other areas of specialty/work
Street address
Hezarjarib street.Isfahan
City
Isfahan
Postal code
Phone
+91 73528587
Fax
Email
Naeme.haghighat@gmail.com
Web page address

Sharing plan

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