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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT2015012020737N1 |
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Date of registration:
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2015-05-23 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Assessment of flaxseed oil and sunflower oil consumption effect on serum lipids, glucose, peroxidation lipid factor and blood pressure in metabolic syndrome patients
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Scientific title:
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Comparison of flaxseed oil and sunflower oil consumption effect on serum triglyceride, HDL-cholesterol, LDL-cholesterol, glucose, MDA and blood pressure in metabolic syndrome patients. |
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Date of first enrolment:
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2015-04-04 |
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Target sample size:
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60 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/18335 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization in intervention and control group in form of block.
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Phase:
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3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Atefe Akrami
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Address:
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School of Nutrition, Razi Blvd., Shiraz, Iran
Shiraz
Iran (Islamic Republic of) |
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Telephone:
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+98 71 3725 7288 |
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Email:
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akramiat@sums.ac.ir; atefe.akrami@yahoo.com |
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Affiliation:
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School of Nutrition, Shiraz University of Medical Sciences |
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Name:
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Siavash Babajafari
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Address:
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School of Nutrition, Razi blvd., Shiraz, Iran
Shiraz
Iran (Islamic Republic of) |
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Telephone:
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+98 71 3725 7288 |
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Email:
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jafaris@sums.ac.ir |
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Affiliation:
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School of Nutrition, Shiraz University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: waist circumference men = 102cm or 40in and women = 88cm or 35in; fasting blood glucose = 110 mg per dl; HDL cholesterol for men < 40 mg per dl and for women < 50 mg per dl; triglycerides = 150 mg per dl; blood pressure = 130 and 85 mm Hg
Exclusion criteria: hypothyroidism; alcoholism; smoking; auto immune disease; chronic pancreatitis; liver dysfunction; kidney disorder or nephritic syndrome; simultaneous subscription in other interventional study; any inflammatory disease or incidence of infection at start or during the study period; consumption of other drug such as aspirin or any NSAID; propranolol; any form of steroids and any kind of lipid lowering agent; angioplasty or heart attack positive history; pregnancy and lactating
Exclusion criteria:
Age minimum:
30 years
Age maximum:
60 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Metabolic disorder, unspecified
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metabolic syndrome.
Metabolic disorder, unspecified
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Intervention(s)
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Intervention 1: 25 cc cold press flaxseed oil daily add to salad or cold food for 7 week. Intervention 2: 25 cc sunflower oil daily add to salad or cold food for 7 week.
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25 cc sunflower oil daily add to salad or cold food for 7 week
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25 cc cold press flaxseed oil daily add to salad or cold food for 7 week
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Treatment - Other
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Primary Outcome(s)
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HDL-cholesterol. Timepoint: Begining of study first day and at the end of study 49th. Method of measurement: Laboratory kit, Pars Azmoon.
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LDL-cholesterol. Timepoint: Begining of study first day and at the end of study 49th day. Method of measurement: Laboratory kit, Pars Azmoon.
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Blood Pressure (systolic and diastolic). Timepoint: Begining of study first day and at the end of study 49th day. Method of measurement: Beurer upper arm digital blood pressure monitor.
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Waist circumference. Timepoint: Begining of study first day and at the end of study 49th day. Method of measurement: By measure tape least circumference between last rib and iliac crest.
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Fasting Blood Glucose. Timepoint: Begining of study first day and at the end of study 49th day. Method of measurement: Laboratory kit, Pars Azmoon.
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MDA. Timepoint: Begining of study first day and at the end of study 49th day. Method of measurement: Reaction serum MDA with tiobarbituric acid, measure absorption with florimetry and comparison with standard curve.
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Triglyceride. Timepoint: Begining of study first day and at the end of study 49th day. Method of measurement: Laboratory kit, Pars Azmoon.
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Source(s) of Monetary Support
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Vice Chancellor for research of Shiraz University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics Commitee of Shiraz University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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