Evaluation of the Effect of Daily Consumption of Sodium Bicarbonate Water for 15 Days on Blood Pressure in Normotensive Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline mean number of systolic and diastolic blood pressure at 15 days
研究概览
简要总结
ROX_TENSIO18 is a randomised cross-over trial and the main objective is to evaluate the effect of daily consumption of sodium bicarbonate water for 15 days on blood pressure.
Secondary objective are:
- Evaluation of the effect of daily consumption of sodium bicarbonate water on total salt intake
- Evaluation on blood pressure of the usual food groups that are the strongest contributors of salt intake.
详细描述
Volunteers are normotensive subjects divided into two equivalent groups. Group A subjects will begin their first 15-day period with the consumption of St-Yorre mineral water.
Group B will begin the first 15-day period by drinking tap water. After a washout period of 15 days, each group alternates with a new period of 15 days of water consumption monitoring: tap water for group A and mineral water St-Yorre for group B.
For each period salt intake and blood pressure are measured.Three-day food records are also performed for both 15-days periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal blood pressure between 90/60 and 140/90 mm Hg
- •Usually drinks tap water;
- •Knowing read and write French routinely,
- •Possessing an internet connection at home,
- •Possessing and knowing how to use a computer or tablet,
- •Affiliated with a social security scheme
- •Not Trust
- •Having signed the informed consent letter
排除标准
- •Pregnant or lactating woman
- •BMI greater than 35 kg / m²
- •Heart failure
- •History of cardiovascular disease
- •Hypertension treated or untreated
- •Renal failure.
研究组 & 干预措施
Group B : tap water and sodium bicarbonate-rich mineral water
First 15-days period with daily intake of 1.5l of tap water. 15-days washout period Last 15-days period with daily intake of 1.5l of sodium bicarbonate-rich mineral water.
干预措施: Sodium bicarbonate-rich mineral water (Other)
Group A : sodium bicarbonate-rich mineral water and tap water
First 15-days period with daily intake of 1.5l of sodium bicarbonate-rich mineral water.
15-days washout period Last 15-days period with daily intake of 1.5l of tap water.
干预措施: Sodium bicarbonate-rich mineral water (Other)
结局指标
主要结局
Change from baseline mean number of systolic and diastolic blood pressure at 15 days
时间窗: Day 1 to Day 3 - Day 13 to Day 15- Day 31 to Day 33 - Day 43 to Day 45
The primary endpoint is the difference between mean number of blood pressure of the volunteers drinking sodium bicarbonated-rich water during 15 days and the mean number of volunteers drinking tap water during 15 days.
次要结局
- Sodium intake(Day 1 to Day 15 - Day 31 to Day 45)