Ignite Creation Date:
2024-05-06 @ 1:39 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01863576
Status:
COMPLETED
Last Update Posted:
2016-09-09
First Post:
2013-05-22
Brief Title:
Effects of Omega-3 Supplementation on the Cytokine and Lipid Profiles in Patients With Chronic Chagas Cardiomyopathy
Sponsor:
Evandro Chagas Institute of Clinical Research
Organization:
Evandro Chagas Institute of Clinical Research
Study Overview
Official Title:
Effects of Omega-3 Polyunsaturated Fatty Acid Supplementation on the Cytokine and Lipid Profiles in Patients With Chronic Chagas Cardiomyopathy a Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this trial is to study the effects of omega-3 PUFA supplementation on the inflammatory response and lipid profile in patients with chronic Chagas cardiomyopathy
Study Type Interventional
Study Design A total 40 patients will be randomly assigned into two parallel groups The intervention will be treatment with omega-3 PUFAs at a dose of 3 gday for 8 weeks compared to placebo corn oil The primary endpoints will be the concentrations of inflammatory markers IL-1 IL-2 IL-4 IL-6 IL-10 TNF-alpha IFN-γ and TGF-β Secondary endpoints will be the fasting glucose lipid and anthropometric profiles
Study Type Interventional
Study Design A total 40 patients will be randomly assigned into two parallel groups The intervention will be treatment with omega-3 PUFAs at a dose of 3 gday for 8 weeks compared to placebo corn oil The primary endpoints will be the concentrations of inflammatory markers IL-1 IL-2 IL-4 IL-6 IL-10 TNF-alpha IFN-γ and TGF-β Secondary endpoints will be the fasting glucose lipid and anthropometric profiles
Detailed Description:
Several studies have shown the beneficial effects of polyunsaturated fatty acids on inflammatory processes dyslipidemia and cardiovascular diseases there are no reports about food intake and PUFA supplementation in chronic Chagas cardiomyopathy patients Thus the objective of this study is to assess the effects of omega-3 PUFA supplementation on the lipid profile and the pro-inflammatory and anti-inflammatory cytokine profiles in chronic Chagas cardiomyopathy patients
After patients are selected by cardiologists they will be seen by study nutritionists who will explain the study procedures to the patients and administer the free and informed consent form The patients who agree to participate in the study will sign the consent form and undergo the initial assessment
The following data will be collected and evaluated in the study sociodemographic data age sex ethnicityrace education and domicile clinical data functional class and vital signs alcoholism smoking prescription drugs 3-day food record 24-hour recall anthropometric assessment height weight BMI waist circumference tricipital skinfold thickness and arm circumference lipid profile total cholesterol triglycerides HDL-c LDL-c and VLDL-c and cytokines IL-1 IL-2 IL-4 IL-6 IL-10 TNF-alpha IFN-γ and TGF-β Clinical nutritional and anthropometric assessments will take place immediately before starting the intervention and after 4 and 8 weeks during the study lipid profile and cytokines will be evaluated before the intervention and at the end of 8 weeks Each patient will be followed for 8 weeks
After patients are selected by cardiologists they will be seen by study nutritionists who will explain the study procedures to the patients and administer the free and informed consent form The patients who agree to participate in the study will sign the consent form and undergo the initial assessment
The following data will be collected and evaluated in the study sociodemographic data age sex ethnicityrace education and domicile clinical data functional class and vital signs alcoholism smoking prescription drugs 3-day food record 24-hour recall anthropometric assessment height weight BMI waist circumference tricipital skinfold thickness and arm circumference lipid profile total cholesterol triglycerides HDL-c LDL-c and VLDL-c and cytokines IL-1 IL-2 IL-4 IL-6 IL-10 TNF-alpha IFN-γ and TGF-β Clinical nutritional and anthropometric assessments will take place immediately before starting the intervention and after 4 and 8 weeks during the study lipid profile and cytokines will be evaluated before the intervention and at the end of 8 weeks Each patient will be followed for 8 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None