Effect of High Nitrate Vegetable Juice Supplementation on Plasma Nitrate and Blood Pressure in Healthy Adults: a Pilot Randomised Crossover Intervention in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Blood pressure (clinic-based)
研究概览
简要总结
Aims: The aim of this study is to carry out a randomised crossover intervention study examining the effect of two different high nitrate vegetable juices on plasma nitrate levels and blood pressure (BP) in healthy adults.
Objectives: 1) to conduct a pilot cross-over randomized intervention study testing the hypothesis that the health benefits of two different high nitrate vegetable juices products will be similar; 2) to measure the volunteers' BP as the primary outcome; and 3) to collect biological samples over the course of this study for the measurement of proposed biomarkers of nutritional status, including plasma nitrate.
详细描述
In this study, it is hypothesized that oral supplementation with different vegetable juices (beetroot and green leafy vegetable) juice, with similar nitrate content, over a one week period, will decrease BP in healthy volunteers to a similar extent.
Plan of Investigation: This study will be a randomised, controlled, crossover (2 groups) trial of beetroot juice and green leafy vegetable juice.
Participants A total of 16 healthy volunteers will be recruited (male and female), according to the stated inclusion and exclusion criteria.
Recruitment Subjects will be screened and recruited from the general population through advertisement, through local community groups and staff intranet postings (university setting). The investigators have established mechanisms for recruiting from these populations that have proven to be effective in previous studies.
Study design Following screening, eligible participants will give informed written consent. Participants will be randomized, using computer-generated random numbers, to two groups.
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
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Aged 30-65 years
排除标准
- •Diabetes mellitus
- •An acute coronary syndrome or transient ischaemic attack within the past 3 months
- •Special dietary requirements, food sensitivities or vegetarian/ vegan diet by choice
- •Oral anticoagulation therapy
- •Recent beetroot juice (or other nitrate) supplementation.
- •BMI>35 kg/m2
- •Excessive alcohol consumption ( >14 U/week for men and women)
- •Current smoker
- •Pregnancy/ lactation
- •Medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements
结局指标
主要结局
Blood pressure (clinic-based)
时间窗: After seven days
Clinic-based blood pressure using automated, calibrated blood pressure monitor, measured twice from the right arm, using an automated Omron sphygmomanometer, with the participant sitting quietly for at least five minutes.
Blood pressure (home-assessed)
时间窗: Two hours post juice consumption during the intervention
An automated BP monitor (Omron M2Basic, Omron Healthcare) will be provided to each participant to measure daily resting BP at home. Participants will be asked to conduct duplicate measurements, in a seated position prior to juice consumption and at 2 hours after juice drinking and they will be trained on how to use the monitor, with an emphasis on the correct positioning of the cuff and arm. In addition, written instructions on measuring BP will be provided. Participants will be provided with a record sheet to record their measurements.
次要结局
- Participant views on interventions(At end of the seven day intervention)
- Serum nitrate and nitrite concentrations(After seven days)
研究者
Jayne Woodside, PhD
Professor
Queen's University, Belfast