Effect of Curcumin on Microvascular Response and Tissue Oxygenation

June 24, 2020 updated by: Thiago Alvares, Universidade Federal do Rio de Janeiro

Effect of Curcumin on Microvascular Response and Tissue Oxygenation in Older People

Aging has been associated with reduced bioavailability of nitric oxide(NO) and endotelial dysfunction.Curcumin, a phenolic compound present in the rhizomes of turmeric, possesses cardiovascular protective, anti-inflammatory and antioxidante properties.

The present study is evaluating the effects of ingestion of 10 g of curcumin supplementation (CUR) on microvascular responsiveness and tissue oxygen saturation in the elderly with cardiometabolic risks.Twenty eight older individuals have been submitted to 10 g of curcumin suplementation (CUR) or placebo (PLA) (sucralose). Microvascular responsiveness and tissue oxygen saturation have been measured 120 minutes after interventions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aging has been associated with reduced bioavailability of nitric oxide(NO) and endotelial dysfunction.

Curcumin, a phenolic compound present in the rhizomes of turmeric, possesses cardiovascular protective, anti-inflammatory and antioxidante properties.

The present study is evaluating the effects of ingestion of 10 g of curcumin suplementation(CUR) on endothelial function and muscle oxygen saturation in the elderly at cardiometabolic risks.

The study is randomized, crossed-over, double blind and controlled by placebo.Twenty-eight volunteers have been recruted for the research. They will perform three visits in vascular dymamic laboratory, that is located at the Federal Universite of Rio de Janeiro , campus Macaé. Basic measures have been performed on the first visit: systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR), maximal voluntary contraction (MVC), endothelial function analysis, vascular responsiveness during rest ( TOV) and rhythmic handgrip exercise. On second and third visits, after 10 minutes period of quiet in rest , volunteers are submitted (SBP), (DBP) and (HR), MVC, blood and urine samples are drawn at baseline in order to analyse curcumin absorption and verify oxidative stress markers( vitamin C and malondialdehyde). Moreover , volunteers are submitted to 10 g of curcumin supplementation (CUR) diluted in 400 ml cold water or placebo (sucralose) that is offered in capsules ingested with 400 ml of water. Microvascular responsiveness and muscle oxygen saturation have been is measured 120 minutes after intervention.Urine and blood samples have been drawn again 20 minutes after exercise.

Before each visit, participants are instructed to fast 8 hours avoiding ingestion of high nitrate such as ( sausages, cheeses, dark green leaves, beets), polifenols foods ( tea, coffee, grape juice and cocoa) and curcumin based dressings(turmeric, curry, colorau). Also, participants have been instructed not practice plysical activities and not change food habits during the research period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio De Janeiro
      • Macaé, Rio De Janeiro, Brazil
        • Central Coexistence of the Elderly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Seniors,
  • With two or more risk factors for cardiovascular disease:Dyslipidemia, visceral obesity, hypertension, diabetes mellitus 2 and others.

Exclusion Criteria:

  • Smoking,
  • Use of antioxidant drugs during the experiment period,
  • Allergy to components of curcumin,
  • With previous history of cancer, HIV,
  • Neurodegenerative and osteomioarticular diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Curcumin powder
Curcumin powder - 10g
Dietary supplement: Curcumin powder
10g of curcumin powder
Placebo Comparator: Placebo ( curcumin depleted)
Placebo- sucralose -1g
Dietary supplement: Placebo
1g of sucralose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in microvascular reactivity
Time Frame: Changes from baseline at 120 minutes after nutritional intervention
Microvascular reactivity will be evaluated by using a near-infrared spectroscopy device during a vascular occlusion test.
Changes from baseline at 120 minutes after nutritional intervention
Changes in tissue oxygen saturation
Time Frame: Changes from baseline at 120 minutes after nutritional intervention
Muscle and cerebral oxygen saturation will be evaluated by using a near-infrared spectroscopy device during exercise
Changes from baseline at 120 minutes after nutritional intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in nitric oxide metabolites (plasma nitrate and nitrite)
Time Frame: Changes from baseline at 120 minutes after nutritional intervention
Nitric oxide metabolites will be evaluated by plasma nitrate and nitrite by using a high-performance liquid chromatography system.
Changes from baseline at 120 minutes after nutritional intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal do Rio de Janeiro

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cristina Rezende, UFRJ -Campus Macaé

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 97055018.1.0000.5699

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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