Determination of the effect of bread containing flax 1seed on serum level of Apelin and lipid profile in hyper lipidemic patients to prevent cardiovascular diseaes
Design
48 hyper lipidemic patients are randomly divided in two equal groups clinical trial parallel two blind( researcher and patients)
Settings and conduct
patients from Kashani Hospital were randomly divided into two groups. The rate of lipid profile, Apelin, BMI,wight ,waist circumference and height were measured. In the intervention group, two units of 20% flaxseed bread and the control group intake 2 simple breads. And after 6 weeks the blood sampling will be done again
Participants/Inclusion and exclusion criteria
Inclusion criteria:
High is one of the lipid factors: cholesterol is grater than or equal to 200.triglycerides grater or equal. LDL is grater or equal 130 and rate of HDL is less than 40 for men and 50 mg per deciliter for women(high levels of LDL or cholesterol are essential
Men and women 20-50 years old
Patients who agree to participate in the study
Condition of failure to enter:
1-Tobacco use
2-Adherence to particular diet
3-Consumption of flax seed bread in the last 6 months
4-Pregnancy, breast feeding, menopause
Exclusion criteria:
Incidence of certain diseases, such as diabetes, hypothyroidism, renal failure , cholestasis or the use of drugs such as corticosteroids that affect blood lipids or the occurrence of gastrointestinal diseases during research, so that further research is not possible
Pregnancy during the project
Change in type or dose of anti hyperlipidemia drugs or drugs that affect blood lipids
Participants do not cooperate in different stages of the study
Intervention groups
1- The intervention group: received 2 unit flax seed bread 20%
2- The control group: receives 2 units of bread containing 100 grams of wheat
Main outcome variables
Cholesterol, triglyceride, Apelin, HDL, LDL
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180305038966N1
Registration date:2018-03-29, 1397/01/09
Registration timing:retrospective
Last update:2018-03-29, 1397/01/09
Update count:0
Registration date
2018-03-29, 1397/01/09
Registrant information
Name
Nahid Shakeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4486 1815
Email address
nutrition@mail.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-28, 1396/11/08
Expected recruitment end date
2018-03-28, 1397/01/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effect of bread containing flaxseed on serum level of Apelin and lipid profile in hyperlipidemic patients
Public title
Study of the Effect of bread containing flaxseed on serum level of Apelin and lipid profile in hyperlipidemic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
high is one of the lipid factors: cholesterol is grater than or equal to 200.triglycerides grater or equal. LDL is grater or equal 130 and rate of HDL is less than 40 for men and 50 mg per deciliter for women(high levels of LDL or cholesterol are essential
Men and wemen 20-50 years old
Patients who agree to participate in the study
Exclusion criteria:
Tobacco use
Adherence to a particular diet
Consumption bread of flaxseed in the last 6 months
Pregnancy, breast feeding, menopause
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
48 patients are randomly assigned to two equal groups (lottery) of intervention and placebo
Blinding (investigator's opinion)
Double blinded
Blinding description
Researchers and patients are unaware of the type of bread they are being divided
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Science and Research Tehran
Street address
Shahid hesarak Bivd, university Square
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2018-02-19, 1396/11/30
Ethics committee reference number
IR.IAU.SRB.REC.1396.100
Health conditions studied
1
Description of health condition studied
Hyperlipidemia
ICD-10 code
E78
ICD-10 code description
Disorders of lipoprotein metabolism and other lipidemias
Primary outcomes
1
Description
serum level of LDL
Timepoint
At the beginning of the study and the end of the sixth week
Method of measurement
By enzyme _ mg/dl
2
Description
Serum level of total cholesterol
Timepoint
At the beginning of the study and the end of the sixth week
Method of measurement
By enzyme _ mg/dl
3
Description
Serum level of Apelin
Timepoint
At the beginning of the study and the end of the sixth week
Method of measurement
Eliza_ picogram/ml
4
Description
Serum level of triglyceride
Timepoint
At the beginning of the study and the end of the sixth week
Method of measurement
By enzyme _ mg/dl
5
Description
Serum level of HDL
Timepoint
At the beginning of the study and the end of the sixth week
Method of measurement
By enzyme _ mg/dl
6
Description
Blood pressure
Timepoint
At the beginning of the study and the end of the sixth week
Method of measurement
Digital Manometer mmHg
7
Description
Body mass index
Timepoint
At the beginning of the study and the end of the sixth week
Method of measurement
Formula weight/High2
8
Description
Physical activity
Timepoint
Initially, the middle and end of the sixth week study
Method of measurement
Met questionnaire
9
Description
Food intake
Timepoint
Initially, the middle and end of the sixth week study
Method of measurement
Food frequency questionnaire 3 days
10
Description
Waist
Timepoint
At the beginning of the study and the end of the sixth week
Method of measurement
Strip Meter- centimeters
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: intake 2 unit of bread containing 20 gram of flax seed flour and 80 gram of wheat flour for 6 weeks and twice a day
Category
Prevention
2
Description
Control group: intake 2 unit of simple bread containing 100 gram of wheat flour for 6 weeks and twice a day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashni hospital and patients referred to other hospitals and private clinics in isfahan
Full name of responsible person
Nahid Shakeri
Street address
Kashani Ave, Kashani hospital
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
nutrition@mail.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashani Hospital
Full name of responsible person
Nahid Shakeri
Street address
Kashani Ave , Kashni Hospital
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
nutrition@mail.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashani Hospital
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nahid Shakeri
Position
Master student nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Shahid Hesarak B lvd , University square
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 1815
Email
nutrition@mail.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hasan Entezari
Position
Philosophy Doctor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave, Isfahan University of MedicalSciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 2775
Email
entezari@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nahid Shakeri
Position
Student master nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Shahid Hesarak Blvd, University Square
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 1815
Email
nutrition@mail.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available