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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04458116
• Other study ID #: Denise Mafra9
• Status: Withdrawn
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: May 10, 2021

Study information

• Verified date: February 2024
• Source: Universidade Federal Fluminense
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 10, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Inflammation
• Myocardial Ischemia
• Oxidative Stress

Intervention

Dietary Supplement:
• Curcumin
Participants will receive 1.5 grams of turmeric 95% curcumin for 1 month (3 capsules / day containing 500mg each for 4 weeks).

Locations

Country	Name	City	State
Brazil	Denise Mafra	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	The effects of curcumin supplementation on inflammatory cytokines.	Get blood samples to evaluate the supplementation effects on cytokines	4 months
Secondary	The effects of curcumin supplementation on blood pressure	Measurement of blood pressure	4 months