ProAliFun_6.7_Health Effects of a Low-Salt Bread on Hypertensive Subjects (ProAliFun67)

Technological and Clinical Innovative Protocols for the Production of Functional Foods - 6.7 (ProAliFun67)

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.

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.

Inclusion Criteria:

• arterial hypertension stage I-II
• stable control of blood pressure
• eGFR > 60
• informed consent signed

Exclusion Criteria:

• 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