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.
The aim of this study is to assess the flaxseed oil edible consumption effects on metabolic syndrome. Inclusion criteria: waist circumference for men ≥ 102 cm and for women ≥ 88cm; 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; systolic blood pressure ≥ 130 or diastolic blood pressure ≥ 85 mm Hg. Exclusion criteria: liver dysfunction; smoking; kidney disorder and incidence of any inflammatory disease. This randomized controlled clinical trial will be done on 60 metabolic syndrome patients (30 for control and 30 for intervention group) referred to shiraz healthy heart house for 7 weeks. Patient selection randomize will be done in form of block in two groups (control or intervention). Measurement of serum levels of glucose, HDL cholesterol, LDL cholesterol, triglyceride, MDA and blood pressure will be done at the beginning of the study before treatment and end of study in day 49 after consumption daily of 25 cc flaxseed oil (intervention group) or 25 cc sunflower oil (control group).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012020737N1
Registration date:2015-05-23, 1394/03/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-23, 1394/03/02
Registrant information
Name
Atefe Akrami
Name of organization / entity
School of Nutrition, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 7288
Email address
akramiat@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2015-05-05, 1394/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
Assessment of flaxseed oil and sunflower oil consumption effect on serum lipids, glucose, peroxidation lipid factor and blood pressure in metabolic syndrome patients
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization in intervention and control group in form of block
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences Ethics Commitee, Zand st., Shiraz, Iran
City
Shiraz
Postal code
Approval date
2015-03-10, 1393/12/19
Ethics committee reference number
93-7420
Health conditions studied
1
Description of health condition studied
metabolic syndrome
ICD-10 code
E88.9
ICD-10 code description
Metabolic disorder, unspecified
Primary outcomes
1
Description
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
2
Description
Fasting Blood Glucose
Timepoint
Begining of study first day and at the end of study 49th day
Method of measurement
Laboratory kit, Pars Azmoon
3
Description
Triglyceride
Timepoint
Begining of study first day and at the end of study 49th day
Method of measurement
Laboratory kit, Pars Azmoon
4
Description
HDL-cholesterol
Timepoint
Begining of study first day and at the end of study 49th
Method of measurement
Laboratory kit, Pars Azmoon
5
Description
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
6
Description
LDL-cholesterol
Timepoint
Begining of study first day and at the end of study 49th day
Method of measurement
Laboratory kit, Pars Azmoon
7
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
25 cc cold press flaxseed oil daily add to salad or cold food for 7 week
Category
Treatment - Other
2
Description
25 cc sunflower oil daily add to salad or cold food for 7 week
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Healthy Heart Institute
Full name of responsible person
Maryam Rezaei
Street address
Healthy Heart Institute, Fazilat St., Modares Blvd., Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Ali Poostforush
Street address
Vice Chancellor for Research Affairs of Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
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 Shiraz 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
School of Nutrition, Shiraz University of Medical Sciences
Full name of responsible person
Atefe Akrami
Position
Msc. Candidate for Nutrition
Other areas of specialty/work
Street address
School of Nutrition, Razi Blvd., Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3725 7288
Fax
+98 71 3725 7288
Email
akramiat@sums.ac.ir; atefe.akrami@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nutrition, Shiraz University of Medical Sciences
Full name of responsible person
Siavash Babajafari
Position
Professor Assistant
Other areas of specialty/work
Street address
School of Nutrition, Razi blvd., Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3725 7288
Fax
+98 71 3725 7288
Email
jafaris@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nutrition, Shiraz University of Medical Sciences
Full name of responsible person
Atefe Akrami
Position
Msc. Candidate for Nutrition
Other areas of specialty/work
Street address
School of Nutrition, Razi blvd., Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3725 7288
Fax
+98 71 3725 7288
Email
akramiat@sums.ac.ir; atefe.akrami@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)