Effects of omega-3 polyunsaturated fatty acid supplementation in patients with chronic chagasic cardiomyopathy: study protocol for a randomized controlled trial

Abstract

BackgroundChronic chagasic cardiomyopathy is an inflammatory disease that occurs in approximately 30% of patients infected by the protozoan Trypanosoma cruzi, and it has a profile of high morbidity and mortality. The worst prognosis and the progression of this cardiomyopathy are associated with an exacerbated immune response and the production of proinflammatory cytokines, which also occur in other cardiomyopathies. Some nutrients, including omega-3 polyunsaturated fatty acids (PUFAs), promote the inhibition and/or stimulation of cytokine production. 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 chagasic cardiomyopathy.Methods/DesignThis is a parallel, randomized, placebo-controlled, double-blind clinical trial with 40 patients that will be conducted at a reference unit for Chagas disease patients, where the patients will be selected. The study will include patients with chronic chagasic cardiomyopathy who are 18 years of age or older. The exclusion criteria are (a) ongoing diarrheal disease, (b) inflammatory bowel disease, (c) diabetes or other endocrine disease, (d) use of fibrates, niacin, or statins, (e) use of anti-inflammatory drugs, (f) pregnant and lactating women, (g) use of vitamin, mineral, or omega-3 supplementation during the previous 30 days, (h) hospital admission during the study, and (i) other associated cardiomyopathies. 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 (interleukin (IL)-1, IL-2, IL-4, IL-6, IL-10, tumor necrosis factor (TNF)α, interferon (IFN)γ, and transforming growth factor (TGF)β). Secondary endpoints will be the fasting glucose, lipid, and anthropometric profiles. For statistical analysis, we plan to run either a t test or Wilcoxon test (numerical variables) and Pearson’s χ2 or Fisher’s exact test (categorical data), as appropriate.DiscussionEvidence suggests that the anti-inflammatory action of omega-3 PUFAs may have beneficial effects on chronic chagasic cardiomyopathy, as shown for other cardiomyopathies, due to improved control of the inflammatory response. At the end of the study, we predict that patients will have lower inflammatory markers and an improved metabolic and anthropometric profile.Trial registrationCurrent Controlled Trials NCT01863576

Fish Oil and Inflammation: A Perspective on the Challenges of Evaluating Efficacy inTrypanosoma cruziInfection

“…Recently, a group of Brazilian researchers reported that patients aging >18 years, with a diagnosis of CCC, that received LC n-3 PUFAs capsules (1.8 g EPA and 1.2 g DHA) during an 8-week period, presented modifications in the lipid and inflammatory profile, demonstrated by a decrease in triglycerides and improvements on IL-10 concentration [36]. The same group had already supposed in 2013 that the anti-inflammatory action of LC n-3 PUFAs may have beneficial effects on chronic chagasic cardiomyopathy, and could be translate into a less severe progression of cardiomyopathy, with subsequent reduction in morbidity [37].…”

“…6-Effects of in vivo supplementation of experimental mice during acute T. cruzi infection [22]. 7-Effects of in vivo supplementation of human patients with chronic Chagas cardiomyopathy [37]. Original publication [22].…”

Omega-3 supplementation on inflammatory markers in patients with chronic Chagas cardiomyopathy: a randomized clinical study

“…The present study was a single-center double-blind clinical trial conducted at the Evandro Chagas National Institute of Infectious Disease (Rio de Janeiro, Brazil). The full description of the study protocol have been published previously [ 19 ].…”

Effects of different doses of omega-3 polyunsaturated fatty acids on gut microbiota and immunity

“…It has been reported that omega-3 PUFAs play beneficial effects on human health, including in neurodevelopment ( 1 ), eye function ( 2 ), and liver lipid metabolism ( 3 ). Omega-3 PUFA supplements are used in the treatment or prevention of diseases, such as depression, cardiovascular diseases ( 5 ), and inflammatory bowel disease (IBD) ( 6 ). The beneficial effects of omega-3 PUFAs on human health require adequate doses and duration, as a low dose of omega-3 PUFAs (180 mg of EPA and 120 mg of DHA) for 8 weeks does not have significant effects on inflammatory and oxidative stress markers in people with type 2 diabetes ( 7 ), while a higher dose of omega-3 PUFAs (1,200 mg DHA + EPA) for 12 weeks could improve insulin sensitivity and reduce the triglyceride levels in individuals with a high risk of type 2 diabetes ( 8 ).…”