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

Not Applicable

Withdrawn

• Conditions: Oxidative Stress; Coronary Artery Disease; Inflammation
• Interventions: Dietary Supplement: Curcumin

• Registration Number: NCT04458116
• Lead Sponsor: Universidade Federal Fluminense

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.

Study Timeline

• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-07
• Study Start: 2021-05-10
• Primary Completion: 2021-05-10
• Study Completion: 2021-05-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group.	Curcumin	will receive capsules containing corn starch.
Tumeric Group	Curcumin	participants will receive capsules containing 1.5 grams of turmeric 95% curcumin

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The effects of curcumin supplementation on blood pressure	4 months	Measurement of blood pressure

Trial Locations

Locations (1)

Denise Mafra; 🇧🇷 Rio de Janeiro, RJ, Brazil