Cardiovascular Risk FactorNCT04119752
Effect of Curcumin on Microvascular Response and Tissue Oxygenation
A study testing Curcumin powder in people with Cardiovascular Risk Factor, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Curcumin powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Jan 2019to 24 Jun 2020
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Seniors,
- With two or more risk factors for cardiovascular disease:Dyslipidemia, visceral obesity, hypertension, diabetes mellitus 2 and others.
Who cannot join
- Smoking,
- Use of antioxidant drugs during the experiment period,
- Allergy to components of curcumin,
- With previous history of cancer, HIV,
- Neurodegenerative and osteomioarticular diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Curcumin powder, Placebo
- Keywords
- Curcumin, Microvascular responsiveness, Aging, Tissue oxygen saturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin powderDietary supplement
10g of curcumin powder
PlaceboDietary supplement
1g of sucralose
| Study group | Role | What they receive |
|---|---|---|
| Curcumin powder | Active comparator | Curcumin powder - 10g Receives: Dietary Supplement: Curcumin powder |
| Placebo ( curcumin depleted) | Placebo comparator | Placebo- sucralose -1g Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in microvascular reactivity
Microvascular reactivity will be evaluated by using a near-infrared spectroscopy device during a vascular occlusion test.
Measured: Changes from baseline at 120 minutes after nutritional intervention
Changes in tissue oxygen saturation
Muscle and cerebral oxygen saturation will be evaluated by using a near-infrared spectroscopy device during exercise
Measured: Changes from baseline at 120 minutes after nutritional intervention
Secondary outcomes (1)
Changes in nitric oxide metabolites (plasma nitrate and nitrite)
Nitric oxide metabolites will be evaluated by plasma nitrate and nitrite by using a high-performance liquid chromatography system.
Measured: Changes from baseline at 120 minutes after nutritional intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start4 Jan 2019
- Primary completion5 Apr 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thiago Alvares, Universidade Federal do Rio de Janeiro
- Investigators
- Cristina Rezende, Principal investigator, UFRJ -Campus Macaé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119752
- Sponsor's protocol ID
- 97055018.1.0000.5699
- Status last verified
- Jun 2020
- First submitted
- 24 Apr 2019
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rezende C, Oliveira GV, Volino-Souza M, Castro P, Murias JM, Alvares TS. Turmeric root extract supplementation improves pre-frontal cortex oxygenation and blood volume in older males and females: a randomised cross-over, placebo-controlled study. Int J Food Sci Nutr. 2022 Mar;73(2):274-283. doi: 10.1080/09637486.2021.1972411. Epub 2021 Sep 22.
PubMed 34551650
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Curcumin on Microvascular Response and Tissue Oxygenation in Older People
- ClinicalTrials.gov ID
- NCT04119752
- Acronym / sponsor ID
- 97055018.1.0000.5699
- Conditions
- Cardiovascular Risk Factor
- Keywords
- Curcumin, Microvascular responsiveness, Aging, Tissue oxygen saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 5 Apr 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 8 Oct 2019 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcumin powder | Active comparator | Dietary Supplement: Curcumin powderCurcumin powder - 10g |
| Placebo ( curcumin depleted) | Placebo comparator | Dietary Supplement: PlaceboPlacebo- sucralose -1g |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Seniors,
- With two or more risk factors for cardiovascular disease:Dyslipidemia, visceral obesity, hypertension, diabetes mellitus 2 and others.
Key exclusion criteria (5 listed)
- Smoking,
- Use of antioxidant drugs during the experiment period,
- Allergy to components of curcumin,
- With previous history of cancer, HIV,
- Neurodegenerative and osteomioarticular diseases.
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 |
|---|---|---|
| Curcumin powder10g of curcumin powder | Dietary supplement | Curcumin powder |
| Placebo1g of sucralose | Dietary supplement | Placebo ( curcumin depleted) |
Primary outcome
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 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
1 secondary outcome
Changes in nitric oxide metabolites (plasma nitrate and nitrite)
Time frame: Changes from baseline at 120 minutes after nutritional intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Derived from this study: PubMed 34551650Rezende C, Oliveira GV, Volino-Souza M, Castro P, Murias JM, Alvares TS. Turmeric root extract supplementation improves pre-frontal cortex oxygenation and blood volume in older males and females: a randomised cross-over, placebo-controlled study. Int J Food Sci Nutr. 2022 Mar;73(2):274-283. doi: 10.1080/09637486.2021.1972411. Epub 2021 Sep 22.
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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.
Cristina Rezende principal investigator
UFRJ -Campus Macaé
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 powder in people with Cardiovascular Risk Factor, run by Universidade Federal do Rio de Janeiro 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: finished, as of the sponsor's last update on 26 Jun 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in microvascular reactivity (time frame: Changes from baseline at 120 minutes after nutritional intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04119752, which also lists 1 linked publication.
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 Jun 2020.