Effect of Curcumin on Microvascular Response and Tissue Oxygenation

NCT ID: NCT04119752

Last Updated: 2020-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2020-06-24

Brief 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.

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.

Conditions

Cardiovascular Risk Factor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Curcumin powder

Curcumin powder - 10g

Group Type: ACTIVE_COMPARATOR

Curcumin powder

Intervention Type: DIETARY_SUPPLEMENT

10g of curcumin powder

Placebo ( curcumin depleted)

Placebo- sucralose -1g

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

1g of sucralose

Interventions

Curcumin powder

10g of curcumin powder

Intervention Type: DIETARY_SUPPLEMENT

Placebo

1g of sucralose

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

Thiago Alvares

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristina Rezende

Role: PRINCIPAL_INVESTIGATOR

UFRJ -Campus Macaé

Locations

Central Coexistence of the Elderly

Macaé, Rio de Janeiro, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 34551650 (View on PubMed)

Other Identifiers

97055018.1.0000.5699

Identifier Type: -

Identifier Source: org_study_id