The Curcumin Supplement Effect on Saturation Levels of Muscular Oxygen and Vascular Response in Elderly People
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|ClinicalTrials.gov Identifier: NCT04119752|
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
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 elderly with cardiometabolic risks.Twenty eight elderly individuals have been submitted to 10 g of curcumin suplementation(CUR) or placebo(PLA) (1g of sucralose). Endothelial function and muscle oxygen saturation have been measured 120 minutes after interventions.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Risk Factor||Dietary Supplement: Curcumin powder Dietary Supplement: Placebo||Not Applicable|
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), maximun voluntary contraction(MVC), endothelial function analysis, vascular responsiveness during rest( TOV) and rhytmic 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 suplemetation (CUR) diluted in 400 ml cold water or placebo- (1 g of sucralose) that is offered in white capsules( total of 5 caps) ingested with 400 ml of water. Endothelial function 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 (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Double - Blind|
|Official Title:||The Curcumin Supplement Effect on Saturation Levels of Muscular Oxygen and Vascular Response in Elderly People|
|Actual Study Start Date :||January 4, 2019|
|Estimated Primary Completion Date :||April 5, 2020|
|Estimated Study Completion Date :||July 30, 2020|
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
- 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 muscle oxygen saturation [ Time Frame: Changes from baseline at 120 minutes after nutritional intervention ]Muscle oxygen saturation will be evaluated by using a near-infrared spectroscopy device during exercise
- Changes in nitric oxide metabolites (plasma nitrate and nitrite) [ Time Frame: Changes from baseline at 120 minutes after nutritional intervention ]Nitric oxide metabolites will be evaluated by plasma nitrate and nitrite by using a high-performance liquid chromatography system.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119752
|Contact: Thiago Alvares, PhD||(21)firstname.lastname@example.org|
|Central Coexistence of the Elderly||Recruiting|
|Macaé, Rio De Janeiro, Brazil|
|Contact: Cristina Rezende +5522999341655 email@example.com|
|Principal Investigator:||Cristina Rezende||UFRJ -Campus Macaé|