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

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status: Completed

Conditions: Hypertension

Treatments: Dietary Supplement: Low-sodium diet with low-sodium bread; Dietary Supplement: Low-sodium diet with standard bread

Study type: Interventional

Funder types: Other

Identifiers

NCT03127553

ProAliFun_6.7_CE4373

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 57 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 3 patient groups

A - control

No Intervention group

Description:

Free diet with standard bread

B - low-salt diet with normal bread

Active Comparator group

Description:

Low-sodium diet with standard bread

Treatment:

Dietary Supplement: Low-sodium diet with standard bread

C - low-salt diet with low-salt bread

Experimental group

Description:

Low-sodium diet with low-sodium bread

Treatment:

Dietary Supplement: Low-sodium diet with low-sodium bread