Comparing the effects of consumption of Canola oil and Sunflower oil on
serum markers of bone metabolism and inflammation
in patients with osteoporosis
The aim of this study is comparing the effects of consumption of Canola oil and Sunflower oil on serum markers of bone metabolism and inflammation in patients with osteoporosis. To do this, 40 osteoporotic patients will be selected. Patients will be assigned randomly to one of the two intervention groups. 1. Canola oil Plain 2. Sunflower oil. Each patient will consume 20 percent of diets oil from this oils every day for 3 months. At the first and last visits, dietary and laboratory assessments will be performed for all patients. Primary outcomes are improvement in, serum markers of bone metabolism and inflammation and secondary outcome is prevention of osteoporosis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012084010N5
Registration date:2011-04-14, 1390/01/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-04-14, 1390/01/25
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences & Health Services
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of consumption of Canola oil and Sunflower oil on
serum markers of bone metabolism and inflammation
in patients with osteoporosis
Public title
Canola oil and osteoporosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: to be keen to corporation, Age≥50 years, osteoporosis based on dansitometry, BMI=<30, not consumption of canola oil within the last two months. Exclusion criteria: any other concomitant disease such as diabetes, renal, inflammatory, heart, hepatic, allergy, parathyroid, and malignancies, fracture, receiving any anti-inflammatory and chemotherapy drugs.
Age
From 50 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sci
Street address
West Arghavan St., Farahzadi Blvd., Shahrak Qods
City
Tehran
Postal code
1981619573
Approval date
2011-03-05, 1389/12/14
Ethics committee reference number
39
Health conditions studied
1
Description of health condition studied
Osteoporosis
ICD-10 code
M81
ICD-10 code description
Osteoporosis without pathological fracture
Primary outcomes
1
Description
Improvement of w-3 fatty acid status of diet
Timepoint
Baseline and 3 month after intervention
Method of measurement
Dietary assessments
Secondary outcomes
1
Description
Improvement of inflammation markers
Timepoint
Baseline and 3 month after intervention
Method of measurement
Serum IL-1,IL-4, IL-6 and TNF-α concentrations
2
Description
Improvement of bone metabolism markers
Timepoint
Baseline and 3 month after intervention
Method of measurement
Serum osteocalcin, bone alkalin posphatase, telopeptid collagen1
Intervention groups
1
Description
Control group: Sunflower oil (20 percent of diets oil)
Category
Other
2
Description
Interventiona group: Canola oil (20 percent of diets oil)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
National nutrition and food technology research institute
Full name of responsible person
Dr. Rahebe Shakerhosseini
Street address
West Arghavan St., Farahzadi Blvd., Shahrak Qods
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sci
Full name of responsible person
Dr. Mohammad Hossein Azizi
Street address
West Arghavan St., farahzadi Blvd., Shahrak Qods
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sci
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
National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sci
Full name of responsible person
Mahboube Azemati
Position
PhD student in Nutrition
Other areas of specialty/work
Street address
West Arghavan St., Farahzadi Blvd., Shahrak Qods
City
Tehran
Postal code
Phone
+98 912 370 5131
Fax
Email
drazemati@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sci
Full name of responsible person
Dr. Rahebe Shakerhosseini
Position
PhD in nutrition
Other areas of specialty/work
Street address
West Arghavan St., Farahzadi Blvd., Shahrak Qods
City
Tehran
Postal code
Phone
+98 21 2237 6471
Fax
Email
rshakerhosseini@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)