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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04458116
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
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, SIRT-1), NLPR3 receptor, as well as the levels of inflammatory cytokines (IL-6, TNF-α, PCR, IL-1B, IL 18) and VCAM 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Oxidative Stress Inflammation Dietary Supplement: Curcumin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Curcumin Supplementation Effects on Markers of Cardiovascular Risk, Inflammation, Oxidative Stress and Functional Capacity in Patients With Coronary Arterial Disease
Estimated Study Start Date : November 10, 2020
Estimated Primary Completion Date : August 20, 2021
Estimated Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: Tumeric Group
participants will receive capsules containing 1.5 grams of turmeric 95% curcumin
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).

Placebo Comparator: Placebo Group.
will receive capsules containing corn starch.
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).




Primary Outcome Measures :
  1. The effects of curcumin supplementation on blood pressure [ Time Frame: 4 months ]
  2. The effects of curcumin supplementation on expression of transcription factors (Nrf2 and Nf-kB) [ Time Frame: 4 months ]
  3. The effects of curcumin supplementation on antioxidant enzymes (NQO1, HO-1, SIRT-1) [ Time Frame: 4 months ]
  4. The effects of curcumin supplementation on inflammatory cytokines (IL-6, TNF-alpha, PCR, IL-1B, IL-18) [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458116


Contacts
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Contact: Denise Mafra, PhD 5521985683003 dmafra30@gmail.com
Contact: Ludmila Cardozo, PhD ludmila.cardozo@gmail.com

Sponsors and Collaborators
Universidade Federal Fluminense
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Responsible Party: Universidade Federal Fluminense
ClinicalTrials.gov Identifier: NCT04458116    
Other Study ID Numbers: Denise Mafra9
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidade Federal Fluminense:
Coronary Artery Disease
Curcumin
Oxidative Stress
Inflammation
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Myocardial Ischemia
Inflammation
Pathologic Processes
Arteriosclerosis
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action