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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: Low-sodium diet with standard bread; Dietary supplement: Low-sodium diet with low-sodium 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 Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BA
    • Bari, BA, Italy, 70125
      • AUO Policlinico Consorziale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
• Collaborators: Ospedali Riuniti di Foggia

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 20, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: blood pressure; functional food; salt intake; low-salt bread
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: ProAliFun_6.7_CE4373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO