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

NCT03127553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2017-04-25

No results posted yet for this study

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.

Conditions

Interventions

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

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

Sponsors & Collaborators

  • Ospedali Riuniti di Foggia

    collaborator OTHER

  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

    lead OTHER

Principal Investigators

  • Loreto Gesualdo, MD Full Prof · Head of the Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari Azienda Ospedaliero-Universitaria Consorziale "Policlinico"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-06-30
Completion
2015-08-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03127553 on ClinicalTrials.gov