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

Chagas Cardiomyopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863576
• Other study ID #: 0037.0.009.000-10
• Status: Completed
• Phase: Phase 0
• First received: May 22, 2013
• Last updated: September 8, 2016
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: Evandro Chagas Institute of Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiomyopathies
• Chagas Cardiomyopathy

Intervention

Dietary Supplement:
• 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.
• Placebo Comparator
The group placebo receives 5 capsules / day of corn oil containing 1100mg each, for a period of 8 weeks.

Locations

Country	Name	City	State
Brazil	Evandro Chagas Institute of Clinical Research	RJ	Br

Sponsors (11)

Lead Sponsor	Collaborator
Evandro Chagas Institute of Clinical Research	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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anthropometric measures	The anthropometric assessment will consist of body mass index (BMI), waist circumference, tricipital skinfold thickness, and arm circumference.	8 weeks	No
Primary	Cytokine profile	The primary endpoint of this study will be the cytokine profile. IL-1, IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-?, and TGF-ß 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).	8 weeks	No
Secondary	Lipid profile	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	8 weeks	No