Determining the effect of rice bran oil on clinical and biochemical cardiovascular parameters in patients with coronary artery disease
Design
Clinical trial (Phase II) with 2 groups (control and intervention), with parallel groups, double blinded, randomized. Sample size is 40.
Settings and conduct
The samples will be selected from cardiac patients referring to Heshmat heart center in 2019-2020 after completing the informed consent . The study design is double blinded. Sampling method will be done by balanced random block rather than the allocation of the groups. The lipid lowering drugs will not be discontinued in either of the two groups, and the type and dosage of the drug will be matched in two groups under the supervision of cardiologist .
Participants/Inclusion and exclusion criteria
Inclusion criteria:
20-70 year old patients with coronary reocculsion that have recently angioplasty.
Non-inclusion criteria:
Using vitamin and mineral supplements; antioxidants; fiber supplement; omega-3; history of kidney disease; current consumption of alcoholic beverages.
Intervention groups
Intervention group: rice bran oil, 30 grams daily
Control group: sunflower oil, 30 g daily
Main outcome variables
Weight ; systolic and diastolic BP; cholesterol; TG; LDL; HDL;hSCRP ;TNF-a, uricacid ; FBS; EF index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190313043045N1
Registration date:2019-04-27, 1398/02/07
Registration timing:registered_while_recruiting
Last update:2019-04-27, 1398/02/07
Update count:0
Registration date
2019-04-27, 1398/02/07
Registrant information
Name
Marjan Mahdaviroshan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3361 8177
Email address
mahdaviroshan@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on the Effect of Rice Bran Oil on Clinical and Biochemical Cardiovascular Parameters in Patients with Coronary Artery Disease
Public title
Effect of Rice Bran Oil on Clinical and Biochemical Cardiovascular Parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 20-70 years old
Recently undergoing angioplasty with coronary artery reocclussion
Exclusion criteria:
Use of vitamin and mineral supplements, antioxidants, fiber supplement, omega-3
Having a history of kidney disease
Current consumption of alcoholic beverages
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly divided into two groups. Block randomization method is used to randomly dividing the subjects into two intervention and placebo groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study type is double blinded. Sampling method will be done by balanced random block design than allocation of the groups. The lipid lowering drugs will not be discontinued in either of the two groups, and the type and dosage of the drug will be matched in two groups under the supervision of cardiologists .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Dr. Heshmat Hospital; Baniyani Street; Masala Square; Rasht
City
Rasht
Province
Guilan
Postal code
4193955588
Approval date
2019-02-02, 1397/11/13
Ethics committee reference number
IR.GUMS.REC.1397.485
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery with unstable angina pectoris
Primary outcomes
1
Description
Weight
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
scale
2
Description
systolic and diastolic blood pressure
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
barometer
3
Description
total cholesterol
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
All the kits of the Pars laboratory test model Hitaeh viv
4
Description
TG, LDL, HDL, HSCRP, TNF-α
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
All the kits of the Pars laboratory test model Hitaeh viv
5
Description
uric acid
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
All the kits of the Pars laboratory test model Hitaeh viv
6
Description
fasting glucose
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
All the kits of the Pars laboratory test model Hitaeh viv
7
Description
EF score
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
echocardiography
8
Description
severity of vascular involvement.
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
severity of vascular involvement with measured syntax will be.