HEMODYNAMIC and BIOCHEMICAL RESPONSES to 10 DAYS of BEETROOT JUICE INTAKE in POSTMENOPAUSAL HYPERTENSIVE WOMEN
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Blood Pressure
研究概览
简要总结
The goal of this clinical trial is to verify the hemodynamic and biomarker responses of beetroot juice intake in postmenopausal women with hypertension. The main questions it aims to answer are:
Is beetroot juice dose related to better hemodynamic responses in hypertensive postmenopausal women? Is beetroot juice dose related to better oxidative stress profile responses in hypertensive postmenopausal women?
The investigators will conduct a parallel clinical study with 10 days of intervention, in which 48 women will be randomized into 3 groups: 1) Two shots of beetroot juice intake per day (800mg of NO3-); 2) One shot of beetroot juice intake per day (400mg of NO3-); 3) placebo intake (beetroot juice without NO3-).
详细描述
The entire intervention will take place at the Physical Education campus of University, in the Cardiorespiratory and Metabolic Physiology Laboratory (LAFICAM). The recruitment and approach of the volunteers will occur through media dissemination, such as radio announcements, television programs, and social media through digital media. After the dissemination, volunteers will make contact via phone, email, or social media, and a preliminary registration will take place. After this registration, the researchers will verify which volunteers meet the inclusion criteria, and only then will the recruitment take place.
The volunteers will be invited to come to LAFICAM to be informed about the intervention program and then sign the informed consent form. Before starting the intervention program, all volunteers must present a medical certificate clearing them to participate in a physical exercise training program; once the certificate is submitted, initial tests and general evaluations will be conducted.
The initial evaluations will consist of a questionnaire, anthropometric and body composition assessment, and evaluation of the physical activity level. After the questionnaires are administered, a familiarization with the sensory perceptions of beetroot juice will be conducted. This familiarization is important to verify if the volunteers are fit to carry out the intervention.
The volunteers will be randomized into three groups: Group 1: the volunteers will ingest two shots containing 70 ml of beetroot juice with 400 mg of nitrate per day, one shot in the mornig and one shot at night, for 10 days; Group 2: this group will intake 70 ml of beetroot juice with 400 mg of nitrate every morning.
Group 3: this group will intake 70 ml of beetroot juice without nitrate for 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Amenorrhea for at least 12 months
- •Controlled hypertension
排除标准
- •Decompensated hypertension in stages 2 and 3
- •Having a history of stroke or acute myocardial infarction
- •Having a diagnosis of Diabetes Mellitus
- •Using hormone therapy.
结局指标
主要结局
Blood Pressure
时间窗: 11 days
Volunteers will undergo blood pressure tests at the beginning, in the middle and after the 10 days of intervention. To assess blood pressure (BP), researchers will use the Dyna Mapa + Cardius® device, programmed with measurements to be taken every 20 min. Together with this device, the volunteers filled out a daily record of activities such as sleep, work, food, or any event that could interfere with BP or measurements. In a standardized manner, the device was set at 7 a.m., and measurements were considered valid when 24h of monitoring were obtained. Resting BP was measured with the same device after 15 min of rest in a sitting position, and for the analysis of the pressure curve, time 0 was adopted when the monitor was placed. Sytolic BP, diastolic BP, and mean BP in periods of awake, sleep and 24 h were analyzed.
次要结局
- Stroop color and word test(11 days)
- Heart rate variability(11 days)
- Superoxide Dismutase(11 days)
- Catalase(11 days)
- Glutathione Peroxidase(11 days)
- Total antioxidant capacity due to ferric-reducing antioxidant power (FRAP)(11 days)
- Reduced glutathione (GSH)(11 days)
- Human cytokines(11 days)
研究者
Ana Luiza Amaral Ribeiro
Principal Investigator
Federal University of Uberlandia