Clinical trial NCT04458116: Effects of Curcumin on Markers of Cardiovascular Risk in Patients With CAD
Official title: Curcumin Supplementation Effects on Markers of Cardiovascular Risk, Inflammation, Oxidative Stress and Functional Capacity in Patients With Coronary Arterial Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Artery Disease
Oxidative Stress
Inflammation
Keywords: Coronary Artery Disease
Curcumin
Oxidative Stress
Inflammation
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: - 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The effects of curcumin supplementation on the expression of transcription factors
timeFrame: 4 months
measure: The effects of curcumin supplementation on antioxidant enzymes.
timeFrame: 4 months
measure: The effects of curcumin supplementation on inflammatory cytokines.
timeFrame: 4 months
Secondary outcomes:
measure: The effects of curcumin supplementation on blood pressure
timeFrame: 4 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Denise Mafra
state: RJ
Study officials:
References: