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

Primary Purpose

Coronary Artery Disease, Oxidative Stress, Inflammation

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Curcumin
Sponsored by
Universidade Federal Fluminense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Curcumin, Oxidative Stress, Inflammation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Denise Mafra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tumeric Group

Placebo Group.

Arm Description

participants will receive capsules containing 1.5 grams of turmeric 95% curcumin

will receive capsules containing corn starch.

Outcomes

Primary Outcome Measures

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)
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
The effects of curcumin supplementation on inflammatory cytokines.
Get blood samples to evaluate the supplementation effects on cytokines

Secondary Outcome Measures

The effects of curcumin supplementation on blood pressure
Measurement of blood pressure

Full Information

First Posted
May 28, 2020
Last Updated
May 19, 2021
Sponsor
Universidade Federal Fluminense
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1. Study Identification

Unique Protocol Identification Number
NCT04458116
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 10, 2022 (Anticipated)
Primary Completion Date
November 20, 2022 (Anticipated)
Study Completion Date
November 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Federal Fluminense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Oxidative Stress, Inflammation
Keywords
Coronary Artery Disease, Curcumin, Oxidative Stress, Inflammation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tumeric Group
Arm Type
Experimental
Arm Description
participants will receive capsules containing 1.5 grams of turmeric 95% curcumin
Arm Title
Placebo Group.
Arm Type
Placebo Comparator
Arm Description
will receive capsules containing corn starch.
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumin
Intervention Description
Participants will receive 1.5 grams of turmeric 95% curcumin for 1 month (3 capsules / day containing 500mg each for 4 weeks).
Primary Outcome Measure Information:
Title
The effects of curcumin supplementation on the expression of transcription factors
Description
Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1)
Time Frame
4 months
Title
The effects of curcumin supplementation on antioxidant enzymes.
Description
Get blood samples to evaluate the supplementation effects in antioxidants biomarkers glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1), NQO1
Time Frame
4 months
Title
The effects of curcumin supplementation on inflammatory cytokines.
Description
Get blood samples to evaluate the supplementation effects on cytokines
Time Frame
4 months
Secondary Outcome Measure Information:
Title
The effects of curcumin supplementation on blood pressure
Description
Measurement of blood pressure
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Mafra, PhD
Phone
5521985683003
Email
dmafra30@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ludmila Cardozo, PhD
Email
ludmila.cardozo@gmail.com
Facility Information:
Facility Name
Denise Mafra
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22260050
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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