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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
low-sodium diet (2300 mg Na/die) with use of standard bread (750 mg Na/100g) for 6 months
low-sodium diet (2300 mg Na/die) with use of low-salt bread (280 mg Na/100g) for 6 months
AUO Policlinico Consorziale
Bari, BA, Italy
Sodium intake
Reduction of sodium intake in diet with the introduction of the innovative formulation of low-salt bread
Time frame: 6 months
Blood pressure
Reduction of blood pressure
Time frame: 6 months
Endothelial stress
Improvement of flow-mediated dilation FMD
Time frame: 6 months
Gut microbiota
Evaluation of gut microbiota modulation
Time frame: 6 months
Antioxidant status
Evaluation of the antioxidant/oxidant ratio of blood
Time frame: 6 months
Inflammation
State of sub-clinical inflammation
Time frame: 6 months
Insulin sensitivity
Reduction of insulin sensitivity
Time frame: 6 months
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