NCT03127553

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

April 10, 2017

Last Update Submit

April 20, 2017

Conditions

Hypertension

Keywords

salt intakefunctional foodlow-salt breadblood pressure

Outcome Measures

Primary Outcomes (1)

  • Sodium intake

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

    6 months

Secondary Outcomes (6)

  • Blood pressure

    6 months

  • Endothelial stress

    6 months

  • Gut microbiota

    6 months

  • Antioxidant status

    6 months

  • Inflammation

    6 months

  • +1 more secondary outcomes

Study Arms (3)

A - control

NO INTERVENTION

Free diet with standard bread

B - low-salt diet with normal bread

ACTIVE COMPARATOR

Low-sodium diet with standard bread

Dietary Supplement: Low-sodium diet with standard bread

C - low-salt diet with low-salt bread

EXPERIMENTAL

Low-sodium diet with low-sodium bread

Dietary Supplement: Low-sodium diet with low-sodium bread

Interventions

Low-sodium diet with standard breadDIETARY_SUPPLEMENT

low-sodium diet (2300 mg Na/die) with use of standard bread (750 mg Na/100g) for 6 months

B - low-salt diet with normal bread
Low-sodium diet with low-sodium breadDIETARY_SUPPLEMENT

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

C - low-salt diet with low-salt bread

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • arterial hypertension stage I-II
  • stable control of blood pressure
  • eGFR \> 60
  • informed consent signed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AUO Policlinico Consorziale

Bari, BA, 70125, Italy

Location

Related Publications (1)

  • Cosola C, Pesce F, De Angelis M, Maranzano V, Zito A, Montemurno E, Dalfino G, Loiudice S, Creanza V, Pompa G, Ciccone MM, Grandaliano G, Stallone G, Gesualdo L. Effects of low-sodium bread on dietary compliance and fecal cultivable bacteria in a randomized controlled pilot trial in hypertensive subjects. BMC Nutr. 2024 Feb 21;10(1):31. doi: 10.1186/s40795-024-00838-w.

    PMID: 38383476DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Loreto Gesualdo, MD Full Prof

    Head of the Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari Azienda Ospedaliero-Universitaria Consorziale "Policlinico"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 25, 2017

Study Start

December 1, 2014

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

April 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)