Effect of Curcumin on Microvascular Response and Tissue Oxygenation

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119752
• Other study ID #: 97055018.1.0000.5699
• Status: Completed
• Phase: N/A
• Start date: January 4, 2019
• Est. completion date: June 24, 2020

Study information

• Verified date: June 2020
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 24, 2020
• Est. primary completion date: April 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Dietary Supplement:
• Curcumin powder
10g of curcumin powder
• Placebo
1g of sucralose

Locations

Country	Name	City	State
Brazil	Central Coexistence of the Elderly	Macaé	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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