An Early Phase 1 interventional study of Omega-3 and Placebo Comparator in Chagas Cardiomyopathy, sponsored by Evandro Chagas Institute of Clinical Research. Completed at 1 site in Brazil. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-09-09.
Sponsored by Evandro Chagas Institute of Clinical Research · Early Phase 1, Interventional, and Health services research
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 g/day 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.
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, ethnicity/race, 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.
20 studies on the registry are indexed under Chagas Cardiomyopathy; 2 are open to participants now.
This study's enrollment of 40 is below the median of 53 across 14 interventional studies indexed under Chagas Cardiomyopathy.
Browse Chagas Cardiomyopathy studies →Evandro Chagas Institute of Clinical Research is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group is receiving omega-3 supplement.
Dietary Supplement: Omega-3
This group is receiving the placebo comparator.
Dietary Supplement: Placebo Comparator
The group omega-3 receives 5 capsules / day, each capsule containing 1100mg of lipids, and 600 mg of omega-3, 3g of omega-3 per day (1.8 g EPA and 1.2 g DHA) for a period of 8 weeks.
Also known as: Oil fish, omega 3 fatty acids, polyunsaturated fatty acids
The group placebo receives 5 capsules / day of corn oil containing 1100mg each, for a period of 8 weeks.
Also known as: Oil Corn
Cytokine profile
The primary endpoint of this study will be the cytokine profile. IL-1, IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-γ, and TGF-β will be measured in the serum of patients using specific sandwich enzyme-linked immunosorbent assays. Capture and detection antibodies will be obtained from eBioscience (San Diego, CA, USA).
Time frame: 8 weeks
Lipid profile
Total cholesterol, triglycerides, and high-density lipoprotein cholesterol (HDL-c) will be measured with enzymatic-colorimetric assays using Siemens reagents on a Siemens Dimension RXL chemistry analyzer (Siemens Healthcare Diagnostics, Tarrytown, NY, USA). Low-density lipoprotein cholesterol (LDL-c) and VLDL-c will be calculated according to the Friedewald equation
Time frame: 8 weeks
Anthropometric measures
The anthropometric assessment will consist of body mass index (BMI), waist circumference, tricipital skinfold thickness, and arm circumference.
Time frame: 8 weeks
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Evandro Chagas Institute of Clinical Research