NCT03127553

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-06-01
• Completion: 2015-08-01
• First posted: 2017-04-25
• Last updated: 2017-04-25

Locations

1 site across 1 country: Italy