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临床试验/NCT05384340
NCT05384340招募中不适用

Nitrate-rich Beet Juice Intake and Aerobic Exercise on Cardiovascular Health of Postmenopausal Women With Arterial Hypertension

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Values of systolic and diastolic blood pressure (mmHg)

研究概览

简要总结

In the context of physical exercise, there is no evidence of the acute and continued use of beetroot juice with a previously recommended dose of nitrate (NO3) (>300mg) on the cardiovascular performance of hypertensive and postmenopausal women. We will investigate the effects of beetroot juice rich in NO3 acutely (first day: 140mL/800mg) and during a week with daily doses (second to the seventh day: 70mL/400mg) on blood pressure, heart rate (HR), cardiac autonomic control, EF, inflammatory, hormonal, and stress biomarkers oxidative stress and enzymes involved in nitric oxide synthesis and mitochondrial regulation, under resting conditions, as well as mediated by submaximal aerobic exercise sessions. Through a randomized, crossover, triple-blind, placebo-controlled clinical trial, 20 physically inactive hypertensive women will undergo an acute and 7-day trial, each with two intervention protocols: 1) placebo and 2) beetroot; in which will ingest beet juice with or without NO3 in its composition with a 7-day washout interval. On collection days, exercise will be performed on a treadmill for 40 minutes at a speed corresponding to 65-70% of VO2peak. The collection of variables (cardiovascular, autonomic, and blood samples for molecular analyses) of the study will take place at rest (120 minutes after ingestion of the intervention), during exercise (40 minutes), and in the effort recovery stage (during 65 minutes) based on previously validated protocols. The collections were arranged so that the measurement of one variable does not interfere with the other and that they have adequate intervals between them.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with 50 to 65 old years;
  • Physically inactive;
  • Postmenopausal diagnosis (amenorrhea for 12 months or more);
  • Arterial hypertension diagnosis (previously);
  • Systolic blood pressure values >120mmHg up to 159mmHg and diastolic blood pressure values >80mmHg up to 99mmHg.

排除标准

  • Previous history of acute myocardial infarction and/or stroke;
  • Allergy or intolerance to nitrate, gluten, or milk;
  • Medications (proton pump inhibitors, beta-blockers, calcium channels antagonists).

结局指标

主要结局

Values of systolic and diastolic blood pressure (mmHg)

时间窗: up to 2 years

次要结局

  • Blood concentrations of C-reactive protein, Interleukin-6 and Interleukin-10 (ng/mL)(up to 2 years)
  • Blood concentration of Hormone-sensitive lipase (mmol/min per kg DM)(up to 2 years)
  • Values of heart rate (beats per minute)(up to 2 years)
  • Macrovascular function (Flow mediated dilatation%)(up to 2 years)
  • Values of heart rate variability (ms)(up to 2 years)
  • Blood concentration of Adiponectin (ug/mL)(up to 2 years)
  • Blood concentrations of Epinephrine and Norepinephrine (pg/mL)(up to 2 years)
  • Plasmatic concentrations of nitrate and nitrite (mmol/L)(up to 2 years)

研究者

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

Cicero Jonas R Benjamim

Principal Investigator

University of Sao Paulo

研究点 (1)

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