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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: Low-sodium diet with standard bread
* Dietary Supplement: Low-sodium diet with low-sodium bread


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A - control<br>Free diet with standard bread | |
| Active Comparator: B - low-salt diet with normal bread<br>Low-sodium diet with standard bread | Dietary Supplement: Low-sodium diet with standard bread<br>* low-sodium diet (2300 mg Na/die) with use of standard bread (750 mg Na/100g) for 6 months<br>|
| Experimental: C - low-salt diet with low-salt bread<br>Low-sodium diet with low-sodium bread | Dietary Supplement: Low-sodium diet with low-sodium bread<br>* low-sodium diet (2300 mg Na/die) with use of low-salt bread (280 mg Na/100g) for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sodium intake | Reduction of sodium intake in diet with the introduction of the innovative formulation of low-salt bread | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Reduction of blood pressure | 6 months | 
| Endothelial stress | Improvement of flow-mediated dilation FMD | 6 months | 
| Gut microbiota | Evaluation of gut microbiota modulation | 6 months | 
| Antioxidant status | Evaluation of the antioxidant/oxidant ratio of blood | 6 months | 
| Inflammation | State of sub-clinical inflammation | 6 months | 
| Insulin sensitivity | Reduction of insulin sensitivity | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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salt intake, functional food, low-salt bread, blood pressure