Hypertension
Conditions
Keywords
salt intake, functional food, low-salt bread, blood pressure
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.
Interventions
DIETARY_SUPPLEMENTLow-sodium diet with standard bread
low-sodium diet (2300 mg Na/die) with use of standard bread (750 mg Na/100g) for 6 months
DIETARY_SUPPLEMENTLow-sodium diet with low-sodium bread
low-sodium diet (2300 mg Na/die) with use of low-salt bread (280 mg Na/100g) for 6 months
Sponsors
Ospedali Riuniti di Foggia
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sodium intake | 6 months | Reduction of sodium intake in diet with the introduction of the innovative formulation of low-salt bread |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial stress | 6 months | Improvement of flow-mediated dilation FMD |
| Gut microbiota | 6 months | Evaluation of gut microbiota modulation |
| Blood pressure | 6 months | Reduction of blood pressure |
| Inflammation | 6 months | State of sub-clinical inflammation |
| Insulin sensitivity | 6 months | Reduction of insulin sensitivity |
| Antioxidant status | 6 months | Evaluation of the antioxidant/oxidant ratio of blood |
Countries
Italy
Outcome results
None listed