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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04458116
Enrollment
0
Registered
2020-07-07
Start date
2021-05-10
Completion date
2021-05-10
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Inflammation, Oxidative Stress

Keywords

Coronary Artery Disease, Curcumin, Oxidative Stress, Inflammation

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.

Interventions

DIETARY_SUPPLEMENTCurcumin

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

Sponsors

Universidade Federal Fluminense
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The effects of curcumin supplementation on the expression of transcription factors4 monthsGet 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 monthsGet 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 monthsGet blood samples to evaluate the supplementation effects on cytokines

Secondary

MeasureTime frameDescription
The effects of curcumin supplementation on blood pressure4 monthsMeasurement of blood pressure

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026