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

NCT04458116 | Withdrawn

• 1 other identifier: Denise Mafra9
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Oxidative Stress; Inflammation

Keywords

Coronary Artery Disease; Curcumin; Oxidative Stress; Inflammation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• The effects of curcumin supplementation on inflammatory cytokines.

  Get blood samples to evaluate the supplementation effects on cytokines

  4 months

Secondary Outcomes (1)

• The effects of curcumin supplementation on blood pressure

  4 months

Study Arms (2)

Tumeric Group

EXPERIMENTAL

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

Dietary Supplement: Curcumin

Placebo Group.

PLACEBO COMPARATOR

will receive capsules containing corn starch.

Dietary Supplement: Curcumin

Interventions

Curcumin DIETARY_SUPPLEMENT

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

Placebo Group.; Tumeric Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-smokers
• with a previous diagnosis of coronary artery disease and / or altered myocardial scintigraphy, both performed by a cardiologist.

You may not qualify if:

• autoimmune and infectious diseases
• pregnant and lactating women
• cancer
• AIDS;
• participants using catabolic drugs, antioxidant vitamin supplements and habitual intake of turmeric and turmeric.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Denise Mafra

Rio de Janeiro, Rio de Janeiro, 22260050, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease; Inflammation

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: July 7, 2020
• Study Start: May 10, 2021
• Primary Completion: May 10, 2021
• Study Completion: May 10, 2021
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)