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临床试验/NCT04119752
NCT04119752已完成不适用

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

Universidade Federal do Rio de Janeiro1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年1月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Changes in microvascular reactivity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

Double-blind

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •With two or more risk factors for cardiovascular disease:Dyslipidemia, visceral obesity, hypertension, diabetes mellitus 2 and others.

排除标准

  • •Use of antioxidant drugs during the experiment period,
  • •Allergy to components of curcumin,
  • •With previous history of cancer, HIV,
  • •Neurodegenerative and osteomioarticular diseases.

研究组 & 干预措施

Curcumin powder

Active Comparator

Curcumin powder - 10g

干预措施: Curcumin powder (Dietary Supplement)

Placebo ( curcumin depleted)

Placebo Comparator

Placebo- sucralose -1g

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Changes in microvascular reactivity

时间窗: 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 tissue oxygen saturation

时间窗: Changes from baseline at 120 minutes after nutritional intervention

Muscle and cerebral oxygen saturation will be evaluated by using a near-infrared spectroscopy device during exercise

次要结局

  • Changes in nitric oxide metabolites (plasma nitrate and nitrite)(Changes from baseline at 120 minutes after nutritional intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thiago Alvares

Director

Universidade Federal do Rio de Janeiro

研究点 (1)

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