Coronary Artery DiseaseNCT04458116
Effects of Curcumin on Markers of Cardiovascular Risk in Patients With CAD
A study testing Curcumin in people with Coronary Artery Disease and Oxidative Stress, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Oxidative Stress, Inflammation
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 10 May 2021to 10 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-smokers
- with a previous diagnosis of coronary artery disease and / or altered myocardial scintigraphy, both performed by a cardiologist.
Who cannot join
- autoimmune and infectious diseases
- pregnant and lactating women
- cancer
- AIDS;
- participants using catabolic drugs, antioxidant vitamin supplements and habitual intake of turmeric and turmeric.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Curcumin Supplementation Effects on Markers of Cardiovascular Risk, Inflammation, Oxidative Stress and Functional Capacity in Patients With Coronary Arterial Disease
- 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
Read more
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Oxidative Stress, Inflammation
- Being tested
- Curcumin
- Keywords
- Coronary Artery Disease, Curcumin, Oxidative Stress, Inflammation
- Medical subject headings
- Coronary Artery Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
Participants will receive 1.5 grams of turmeric 95% curcumin for 1 month (3 capsules / day containing 500mg each for 4 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Tumeric Group | Experimental | participants will receive capsules containing 1.5 grams of turmeric 95% curcumin Receives: Dietary Supplement: Curcumin |
| Placebo Group. | Placebo comparator | will receive capsules containing corn starch. Receives: Dietary Supplement: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 4 months
The effects of curcumin supplementation on inflammatory cytokines.
Get blood samples to evaluate the supplementation effects on cytokines
Measured: 4 months
Secondary outcomes (1)
The effects of curcumin supplementation on blood pressure
Measurement of blood pressure
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start10 May 2021 (estimated)
- Primary completion10 May 2021 (estimated)
- Study completion10 May 2021 (estimated)
Why it stopped: We could not start the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458116
- Sponsor's protocol ID
- Denise Mafra9
- Status last verified
- Feb 2024
- First submitted
- 28 May 2020
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curcumin Supplementation Effects on Markers of Cardiovascular Risk, Inflammation, Oxidative Stress and Functional Capacity in Patients With Coronary Arterial Disease
- ClinicalTrials.gov ID
- NCT04458116
- Acronym / sponsor ID
- Denise Mafra9
- Conditions
- Coronary Artery Disease, Oxidative Stress, Inflammation
- Keywords
- Coronary Artery Disease, Curcumin, Oxidative Stress, Inflammation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We could not start the project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 10 May 2021 (estimated)
- Primary completion
- 10 May 2021 (estimated)
- Study completion
- 10 May 2021 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tumeric Group | Experimental | Dietary Supplement: Curcuminparticipants will receive capsules containing 1.5 grams of turmeric 95% curcumin |
| Placebo Group. | Placebo comparator | Dietary Supplement: Curcuminwill receive capsules containing corn starch. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-smokers
- with a previous diagnosis of coronary artery disease and / or altered myocardial scintigraphy, both performed by a cardiologist.
Key exclusion criteria (5 listed)
- autoimmune and infectious diseases
- pregnant and lactating women
- cancer
- AIDS;
- participants using catabolic drugs, antioxidant vitamin supplements and habitual intake of turmeric and turmeric.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminParticipants will receive 1.5 grams of turmeric 95% curcumin for 1 month (3 capsules / day containing 500mg each for 4 weeks). | Dietary supplement | Placebo Group., Tumeric Group |
Primary outcome
The effects of curcumin supplementation on the expression of transcription factors
Time frame: 4 months
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.
Time frame: 4 months
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.
Time frame: 4 months
Get blood samples to evaluate the supplementation effects on cytokines
1 secondary outcome
The effects of curcumin supplementation on blood pressure
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin in people with Coronary Artery Disease and Oxidative Stress, run by Universidade Federal Fluminense at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of curcumin supplementation on the expression of transcription factors (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.