Clinical trial NCT01863576: Effects of Omega-3 Supplementation on the Cytokine and Lipid Profiles in Patients With Chronic Chagas Cardiomyopathy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chagas Cardiomyopathy
Keywords: Chagas disease
Chagas Cardiomyopathy
Trypanosoma cruzi
Omega-3
Cytokines
Lipid profile
Nutritional assessment
Lead sponsor: Evandro Chagas Institute of Clinical Research
Sponsor class: OTHER
Collaborators: name: Andrea Silvestre de Sousa, MD PhD
name: Alejandro Marcel Hasslocher, MD MSc PhD student
name: Andrea Pereira de Souza, PhD
name: Claudia Santos de Aguiar Cardoso, MSc
name: Patricia Dias de Brito, PhD
name: Pedro Emmanuel Alvarenga Americano do Brasil, MD PhD
name: Roberta Olmo Pinheiro, PhD
name: Roberto Magalhães Saraiva, MD PhD
name: Sergio Salles Xavier, MD PhD
name: Paula Simplicio da Silva, MSc PhD student
First posted: 2013-05-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cytokine profile
timeFrame: 8 weeks
Secondary outcomes:
measure: Lipid profile
timeFrame: 8 weeks
Other outcomes:
measure: Anthropometric measures
timeFrame: 8 weeks
Locations:
city: RJ
country: Brazil
facility: Evandro Chagas Institute of Clinical Research
state: Br
Study officials:
affiliation: Evandro Chagas Institute of Clinical Research
name: Andrea S Sousa, MD PhD
role: STUDY_DIRECTOR
References:
citation: Silva PSD, Mediano MFF, Silva GMSD, Brito PD, Cardoso CSA, Almeida CF, Sangenis LHC, Pinheiro RO, Hasslocher-Moreno AM, Brasil PEAAD, Sousa AS. Omega-3 supplementation on inflammatory markers in patients with chronic Chagas cardiomyopathy: a randomized clinical study. Nutr J. 2017 Jun 9;16(1):36. doi: 10.1186/s12937-017-0259-0.
citation: Silva PS, Sperandio da Silva GM, de Souza AP, Cardoso CS, Fonseca CA, Brito PD, Saraiva RM, Brasil PE, Pinheiro RO, Hasslocher-Moreno AM, Xavier SS, Sousa AS. Effects of omega-3 polyunsaturated fatty acid supplementation in patients with chronic chagasic cardiomyopathy: study protocol for a randomized controlled trial. Trials. 2013 Nov 11;14:379. doi: 10.1186/1745-6215-14-379.