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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chagas Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Omega-3

This group is receiving omega-3 supplement.

Group Type ACTIVE_COMPARATOR

Omega-3

Intervention Type DIETARY_SUPPLEMENT

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.

Oil Corn

This group is receiving the placebo comparator.

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DIETARY_SUPPLEMENT

The group placebo receives 5 capsules / day of corn oil containing 1100mg each, for a period of 8 weeks.

Interventions

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Omega-3

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo Comparator

The group placebo receives 5 capsules / day of corn oil containing 1100mg each, for a period of 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Oil fish omega 3 fatty acids polyunsaturated fatty acids Oil Corn

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No