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Completed

NCT Number: NCT03127553

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AUO Policlinico Consorziale

Bari, BA, 70125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-sodium diet with standard bread

Dietary Supplement

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

Dietary Supplement

low-sodium diet (2300 mg Na/die) with use of low-salt bread (280 mg Na/100g) for 6 months

Primary outcomes

  1. Sodium intake

    Time frame: 6 months

    Reduction of sodium intake in diet with the introduction of the innovative formulation of low-salt bread

Secondary outcomes

  1. Blood pressure

    Time frame: 6 months

    Reduction of blood pressure

  2. Endothelial stress

    Time frame: 6 months

    Improvement of flow-mediated dilation FMD

  3. Gut microbiota

    Time frame: 6 months

    Evaluation of gut microbiota modulation

  4. Antioxidant status

    Time frame: 6 months

    Evaluation of the antioxidant/oxidant ratio of blood

  5. Inflammation

    Time frame: 6 months

    State of sub-clinical inflammation

  6. Insulin sensitivity

    Time frame: 6 months

    Reduction of insulin sensitivity

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Collaborators

  • Ospedali Riuniti di Foggia

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 25, 2017
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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