Effects of Omega-3 Supplementation on the Cytokine and Lipid Profiles in Patients With Chronic Chagas Cardiomyopathy

Early Phase 1

Completed

• Conditions: Chagas Cardiomyopathy
• Interventions: Dietary Supplement: Placebo Comparator; Dietary Supplement: Omega-3

• Registration Number: NCT01863576
• Lead Sponsor: Evandro Chagas Institute of Clinical Research

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 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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-23
• Study First Posted: 2013-05-29
• Primary Completion: 2014-01
• Study Completion: 2015-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Volunteers with Chagas Cardiomyopathy at stage B (no heart failure symptoms but with segmental or global left ventricular systolic dysfunction), stage C (symptomatic heart failure), or stage D (end-stage heart failure)), according to the current Brazilian Chagas' Disease Consensus;
• Subjects will include adults, men and women.

Exclusion Criteria

• diarrheal disease;
• inflammatory bowel syndrome;
• diagnosis of diabetes or other endocrine pathologies;
• use of fibrates, niacin, or statins;
• use of anti-inflammatory drugs;
• pregnant and lactating women;
• vitamin mineral or omega-3 supplementation during the previous 30 days;
• hospital admission during the study;
• presence of cardiomyopathies other than Chagas Cardiomyopathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oil Corn	Placebo Comparator	This group is receiving the placebo comparator.
Omega-3	Omega-3	This group is receiving omega-3 supplement.

Primary Outcome Measures

Name	Time	Method
Cytokine profile	8 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Lipid profile	8 weeks	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

Trial Locations

Locations (1)

Evandro Chagas Institute of Clinical Research; 🇧🇷 RJ, Br, Brazil