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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Dietary Supplement: Low-sodium diet with standard bread; Dietary Supplement: Low-sodium diet with low-sodium bread

• Registration Number: NCT03127553
• Lead Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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.

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-06
• Study Completion: 2015-08
• Status Verified: 2017-04
• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-20
• Last Update Submitted: 2017-04-20
• Study First Posted: 2017-04-25
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B - low-salt diet with normal bread	Low-sodium diet with standard bread	Low-sodium diet with standard bread
C - low-salt diet with low-salt bread	Low-sodium diet with low-sodium bread	Low-sodium diet with low-sodium bread

Primary Outcome Measures

Name	Time	Method
Sodium intake	6 months	Reduction of sodium intake in diet with the introduction of the innovative formulation of low-salt bread

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AUO Policlinico Consorziale; 🇮🇹 Bari, BA, Italy