Effect of Curcumin on Microvascular Response and Tissue Oxygenation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Risk Factor

Intervention / Treatment
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* Dietary Supplement: Curcumin powder
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Curcumin powder<br>Curcumin powder - 10g | Dietary Supplement: Curcumin powder<br>* 10g of curcumin powder<br>|
| Placebo Comparator: Placebo ( curcumin depleted)<br>Placebo- sucralose -1g | Dietary Supplement: Placebo<br>* 1g of sucralose<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Curcumin, Microvascular responsiveness, Aging, Tissue oxygen saturation