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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03127553
• Other study ID #: ProAliFun_6.7_CE4373
• Status: Completed
• Phase: N/A
• First received: April 10, 2017
• Last updated: April 20, 2017
• Start date: December 2014
• Est. completion date: August 2015

Study information

• Verified date: April 2017
• Source: Azienda Ospedaliero-Universitaria Consorziale
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	AUO Policlinico Consorziale	Bari	BA

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Consorziale	Ospedali Riuniti di Foggia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sodium intake	Reduction of sodium intake in diet with the introduction of the innovative formulation of low-salt bread	6 months
Secondary	Blood pressure	Reduction of blood pressure	6 months
Secondary	Endothelial stress	Improvement of flow-mediated dilation FMD	6 months
Secondary	Gut microbiota	Evaluation of gut microbiota modulation	6 months
Secondary	Antioxidant status	Evaluation of the antioxidant/oxidant ratio of blood	6 months
Secondary	Inflammation	State of sub-clinical inflammation	6 months
Secondary	Insulin sensitivity	Reduction of insulin sensitivity	6 months