Technological and Clinical Innovative Protocols for the Production of Functional Foods - 6.7 (ProAliFun67)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Sodium intake
研究概览
简要总结
The purpose of this clinical study is to evaluate the health properties of a dietary intervention carried on with an innovative low-salt bread.
The hypothesis is that the introduction of a low-sodium bread as part of a low-salt diet may improve the compliance to the own regime and that the vascular function, the inflammatory and oxidative state, the composition of the intestinal microbiota and that neurocognitive and neurodegenerative processes can improve in hypertensive patients fed a low-salt diet with low-salt bread.
详细描述
This clinical trial is a multi-center, randomized, controlled, open label, pilot study, lasting 6 months.
A target number of seventy individuals with hypertension meeting inclusion and exclusion criteria, assessed at enrollment, and which have signed the informed consent, will be recruited.
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
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •arterial hypertension stage I-II
- •stable control of blood pressure
- •eGFR > 60
- •informed consent signed
排除标准
- •uncontrolled hypertension
- •therapy with diuretics
- •need for therapy with more than three antihypertensive drugs
- •proteinuria greater than 1 g/day
- •celiac disease
- •systemic inflammatory diseases
- •suspicion or clinical diagnosis of malignancy
- •chronic liver disease
- •treatment with corticosteroids or immunosuppressive drugs
- •previous acute cardiovascular diseases (myocardial infarction, stroke)
- •psychiatric conditions reducing the compliance to treatment protocols
结局指标
主要结局
Sodium intake
时间窗: 6 months
Reduction of sodium intake in diet with the introduction of the innovative formulation of low-salt bread
次要结局
- Blood pressure(6 months)
- Endothelial stress(6 months)
- Gut microbiota(6 months)
- Antioxidant status(6 months)
- Inflammation(6 months)
- Insulin sensitivity(6 months)