Effect of Curcumin on Microvascular Response and Tissue Oxygenation

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: Completed
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Dietary supplement: Curcumin powder; Dietary supplement: Placebo

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: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Changes in microvascular reactivity	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	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

Outcome Measure	Measure Description	Time Frame
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.	Changes from baseline at 120 minutes after nutritional intervention

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro
• Investigators: Principal Investigator: Cristina Rezende, UFRJ -Campus Macaé

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2019
• Primary Completion (Actual): April 5, 2020
• Study Completion (Actual): June 24, 2020

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Aging; Curcumin; Tissue oxygen saturation; Microvascular responsiveness
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID 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