Ignite Creation Date:
2024-05-06 @ 2:53 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04458116
Status:
WITHDRAWN
Last Update Posted:
2024-02-26
First Post:
2020-05-28
Brief Title:
Effects of Curcumin on Markers of Cardiovascular Risk in Patients With CAD
Sponsor:
Universidade Federal Fluminense
Organization:
Universidade Federal Fluminense
Study Overview
Official Title:
Curcumin Supplementation Effects on Markers of Cardiovascular Risk Inflammation Oxidative Stress and Functional Capacity in Patients With Coronary Arterial Disease
Status:
WITHDRAWN
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We could not start the project
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None