Effects of Curcumin on Markers of Cardiovascular Risk in Patients With CAD

Study Overview
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Brief Summary
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- General Objective To evaluate the effects of curcumin supplementation on cardiovascular risk markers, inflammation, oxidative stress and functional capacity in participants with coronary artery disease. Specific Objectives Assess, before and after supplementation with turmeric: The nutritional status of the participants; Blood pressure; Atherogenic risk; The expression of transcription factors (Nrf2 and NF-kB), antioxidant enzymes (NQO1, HO-1, sirtuin 1 (SIRT-1)), NLPR3 receptor, as well as the levels of inflammatory cytokines (IL-6, tumor necrosis factor-alpha (TNF-α), protein C reactive (PCR), IL-1, IL 18) and vascular cell adhesion protein 1 (VCAM-1) and E-selectin adhesion molecules; Routine biochemical parameters; Lipid peroxidation and oxidized LDL; The 6-minute walk test, the recovery heart rate and the chair lift test; Modifiable risk factors before and after supplementation; The comparison of all parameters between groups.

Detailed Description
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Coronary Artery Disease (CAD) is the leading cause of death worldwide. CAD refers to the pathological process of atherosclerosis that affects the coronary arteries, often leading to obstruction by an atheromatous plaque. Oxidative stress is one of the most potent inducers of vascular inflammation in atherogenesis. Reactive oxygen species (ROS) regulate through nuclear factor kB (NF-kB), transcription factors and genes related to inflammation, thus, activation of NF-kB by ROS in the atherosclerosis patient is associated with vascular dysfunction and thus with inflammation and atherosclerosis. Recently, researchers have discovered a transcription factor identified as nuclear factor-erythroid 2-related factor 2 (Nrf2) transcription factor, which is responsible for the expression of antioxidant response element genes that can inhibit this pathway, thus providing cellular protection. Thus, several nutritional strategies have been studied, including the use of curcumin, a chemical compound of the class of curcumin produced by turmeric root (Curcuma longa). Turmeric is capable of promoting the activation of nuclear factor-erythroid 2-related factor 2 (Nrf2) transcription factor and inflammasome (NLPR3). These factors, in turn, are involved with the activity of nuclear factor kappa-B (NF-kB), a transcription factor that increases the synthesis of inflammatory cytokines. Thus, the present study aims to evaluate the effects of turmeric supplementation on cardiovascular risk markers, inflammation, oxidative stress and evaluation of functional capacity. Perspectives: This study aims to improve the inflammatory and oxidative stress status of patients with CAD with the use of turmeric, and thus try to reduce the risk factors related to the onset and progression of coronary artery disease.

Official Title
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Curcumin Supplementation Effects on Markers of Cardiovascular Risk, Inflammation, Oxidative Stress and Functional Capacity in Patients With Coronary Arterial Disease

Conditions
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Coronary Artery Disease, Oxidative Stress, Inflammation

Intervention / Treatment
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* Dietary Supplement: Curcumin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Non-smokers with a previous diagnosis of coronary artery disease and / or altered myocardial scintigraphy, both performed by a cardiologist. Exclusion criteria: autoimmune and infectious diseases pregnant and lactating women cancer AIDS; participants using catabolic drugs, antioxidant vitamin supplements and habitual intake of turmeric and turmeric.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Is a longitudinal randomized clinical study where participants will be randomized into two groups: Turmeric Group, in which participants will receive 1.5 grams of turmeric 95% curcumin (ACTIVE PHARMACEUTICA LTDA) for 1 month (3 capsules / day containing 500mg each for 4 weeks), and placebo group, where participants will receive capsules containing corn starch. Randomization will be done in blocks.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tumeric Group<br>participants will receive capsules containing 1.5 grams of turmeric 95% curcumin | Dietary Supplement: Curcumin<br>* Participants will receive 1.5 grams of turmeric 95% curcumin for 1 month (3 capsules / day containing 500mg each for 4 weeks).<br>|
| Placebo Comparator: Placebo Group.<br>will receive capsules containing corn starch. | Dietary Supplement: Curcumin<br>* Participants will receive 1.5 grams of turmeric 95% curcumin for 1 month (3 capsules / day containing 500mg each for 4 weeks).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of curcumin supplementation on the expression of transcription factors | Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1) | 4 months | 
| The effects of curcumin supplementation on antioxidant enzymes. | Get blood samples to evaluate the supplementation effects in antioxidants biomarkers glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1), NQO1 | 4 months | 
| The effects of curcumin supplementation on inflammatory cytokines. | Get blood samples to evaluate the supplementation effects on cytokines | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of curcumin supplementation on blood pressure | Measurement of blood pressure | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, Oxidative Stress, Coronary Artery Disease, Curcumin