Effects of Omega-3 Supplementation on the Cytokine and Lipid Profiles in Patients With Chronic Chagas Cardiomyopathy
Condition: Chagas Cardiomyopathy
MeSH terms: Chagas Cardiomyopathy; Cardiomyopathies
Study type: Interventional
Phase: Early Phase 1

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 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.
    

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, 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.
    

Intervention name(s): Omega-3; Placebo Comparator
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; The group placebo receives 5 capsules / day of corn oil containing 1100mg each, for a period of 8 weeks.
Other intervention name(s): Oil fish; omega 3 fatty acids; polyunsaturated fatty acids; Oil Corn
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Keywords: Chagas disease; Chagas Cardiomyopathy; Trypanosoma cruzi; Omega-3; Cytokines; Lipid profile; Nutritional assessment