Evaluation of the effects of Omega-3 fatty acid(flaxseed oil) and Omega-3 fatty acid(fish oil) on lipid profile, insulin resistance, oxidative stress, and hs-CRP level in patients with metabolic syndrome
This study is a randomized double blind , controlled with placebo and drug , single- center , parallel clinical trial on 105 patients, aged 45 to 75 who have metabolic syndrome with coronary disease in angiography and diabetes with American Diabetes Association and serum LDL levels > 100 that don’t have thyroid disease or smoking .At the baseline volunteers devided to one of the groups received Omega-3 fatty acid(flaxseed oil) pearl, Omega-3 fatty acid(fish oil) pearl or placebo pearl twice a day, for 3 months randomly. Patients don’t change in Physical Activity and food habit which was cheked with standardized questionnaires . At the beginning and end of 3 months of blood samples for determination of total cholesterol, FBS,TG, LDL, HDL, insulin, hs-CRP and QUICKI were recorded and and the results will be compared in each group and between groups .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020412438N22
Registration date:2017-04-21, 1396/02/01
Registration timing:registered_while_recruiting
Last update:
Update count:2
Registration date
2017-04-21, 1396/02/01
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Research Center of Medicinal Herbs
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Omega-3 fatty acid(flaxseed oil) and Omega-3 fatty acid(fish oil) on lipid profile, insulin resistance, oxidative stress, and hs-CRP level in patients with metabolic syndrome
Public title
Effect of Omega-3 fatty acid on patients with metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients with coronary disease on angiography ;patients with diabetes with American Diabetes Association; age 75 to 45 years; - serum LDL levels > 100
Exclusion criteria: thyroid disease;No change in levels of LDL patients six weeks after the intervention; Hypertension patients during the study for any reason; need for insulin in patients during the intervention; smoking
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomized based on table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences