Effects of Tocomas added to canola oil on oxidative-nitrosative stress parameters, insulin sensitivity and microalbuminuria in type 2 diabetic patients
The aim of this study is to investigate the Effect of Tocomas (tocotrienol rich fraction) added to canola oil on oxidative-nitrosative stress parameters, insulin sensitivity and microalbuminuria in type 2 diabetic patients. In this Double blinded randomized controlled trial, 50 men and women with type 2 diabetes aged 35-70 years old, who are eligible for this study, will be recruited from Institute of Endocrinology & Metabolism of Iran University of Medical Sciences. Informed consent form will be completed by each participant at the beginning of the study, participants will be randomly assigned to daily receive either 15 grams of canola oil reached in tocomas suspension in the form of 525 mg tocomas (200 mg tocotrienols) in each 15 grams of canola oil or 15 grams pure canola oil for 8 weeks. Then, we will substitute this oil for daily oil consumption in both groups. Prior to the study, the subjects will be required to complete 3-days 24-hour dietary recall. Diets will be analyzed for calorie and macro_ micronutrients content. Blood samples will be obtained after an overnight fast before and after the study. All anthropometric and physical activity variables will be measured both before and after the trial. Diets and medications dosage will be held constant throughout the study and each subject’s exercise level will be kept constant and monitored by physical activity questionnaires (IPAQ).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008092365N2
Registration date:2010-08-28, 1389/06/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-08-28, 1389/06/06
Registrant information
Name
Mohammad Reza Vafa
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4734
Email address
vafa.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-03-06, 1389/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Tocomas added to canola oil on oxidative-nitrosative stress parameters, insulin sensitivity and microalbuminuria in type 2 diabetic patients
Public title
Effects of Tocomas added to canola oil on oxidative-nitrosative stress parameters, insulin sensitivity and microalbuminuria in type 2 diabetic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Being volunteer or Wishing to attend, 35-60 y old, diagnosed with type 2 diabetes for at least 1 year (FPG ≥ 126 mg/dl or 2hPG ≥ 200 mg/dl), BMI ≤ 40 kg/m2, no cancer or thyroid or liver disease
Exclusion criteria: Taking insulin, Changing medication dosage or physical activity level 2 mo before or during the study, Pregnancy, lactation, dialysis, Using multivitamins, minerals, or other antioxidants during 1 month prior to the study, Using warfarins or other anticoagulant drugs
Age
From 35 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
School of Public Health, Iran University Of Medical Sciences
Street address
Arjantin Square, Alvand Avenue
City
Tehran
Postal code
1516846514
Approval date
2010-07-18, 1389/04/27
Ethics committee reference number
1421
Health conditions studied
1
Description of health condition studied
Non-insulin-dependent diabetes mellitus
ICD-10 code
E-12
ICD-10 code description
Malnutrition-related diabetes mellitus
Primary outcomes
1
Description
Increase Total Antioxidant Capacity (TAC)
Timepoint
8 weeks
Method of measurement
Spectrophotometery
2
Description
decrease nitric oxide (NO)
Timepoint
8 weeks
Method of measurement
colorimeter
Secondary outcomes
1
Description
Fasting Insulin
Timepoint
8 weeks
Method of measurement
RIA
2
Description
HOMA Index
Timepoint
8 weeks
Method of measurement
Calculation
3
Description
high sensitivity C-reactive protein (hs-CRP)
Timepoint
8 weeks
Method of measurement
Immunoturbidimetry
Intervention groups
1
Description
Tocomas added to canola oil (525 mg Tocomas per 15 gram canola oil), substitution with daily oil consumption, for 8 weeks
Category
Prevention
2
Description
canola oil (15 gram) substitution with daily oil consumption, for 8 weeks
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Institute of Endocrinology & Metabolism of Iran University of Medical Sciences
Full name of responsible person
Dr Iraj Heydari
Street address
Institute of Endocrinology & Metabolism of Iran Universityof Medical Sciences, Firozgar Hospital, Vali-Aser Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mohsen Asadi Lari
Street address
Iran University of Medical Sciences, Hemat Express way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Vafa
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Alvand Ave, Arjantin Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
rezavafa@iums.ac.irrezavafa@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)