Technological and Clinical Innovative Protocols for the Production of Functional Foods - 6.7 (ProAliFun67)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Sodium intake
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Sodium intake
Time Frame: 6 months
Reduction of sodium intake in diet with the introduction of the innovative formulation of low-salt bread
Secondary Outcomes
- Blood pressure(6 months)
- Endothelial stress(6 months)
- Gut microbiota(6 months)
- Antioxidant status(6 months)
- Inflammation(6 months)
- Insulin sensitivity(6 months)