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NCT Number: NCT01863576

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

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Evandro Chagas Institute of Clinical Research

Rio de Janeiro, Br|rj, 21040-360, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega-3

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.

Other names: Oil fish, omega 3 fatty acids, polyunsaturated fatty acids

Placebo Comparator

Dietary Supplement

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

Other names: Oil Corn

Primary outcomes

  1. Cytokine profile

    Time frame: 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 outcomes

  1. Lipid profile

    Time frame: 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

Other outcomes

  1. Anthropometric measures

    Time frame: 8 weeks

    The anthropometric assessment will consist of body mass index (BMI), waist circumference, tricipital skinfold thickness, and arm circumference.

Sponsors and collaborators

Lead sponsor

Evandro Chagas Institute of Clinical Research

Other

Collaborators

  • Alejandro Marcel Hasslocher, MD MSc PhD student
  • Andrea Pereira de Souza, PhD
  • Andrea Silvestre de Sousa, MD PhD
  • Claudia Santos de Aguiar Cardoso, MSc
  • Patricia Dias de Brito, PhD
  • Paula Simplicio da Silva, MSc PhD student
  • Pedro Emmanuel Alvarenga Americano do Brasil, MD PhD
  • Roberta Olmo Pinheiro, PhD
  • Roberto Magalhães Saraiva, MD PhD
  • Sergio Salles Xavier, MD PhD

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
May 29, 2013
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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