Microbiota-Inflammation-Brain Axis in Heart Failure: New Functional Food for the Prevention of undeRnutrition in Older

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorAzienda Ospedaliero-Universitaria Careggi

About this trial

The goal of this clinical trial is to learn if the AMBROSIA Bar helps prevent undernutrition and muscle loss in older adults with heart failure or atrial fibrillation.

The main questions it aims to answer are:

Does the AMBROSIA Bar help improve muscle mass and physical performance in older adults with heart conditions? What effects does the AMBROSIA Bar have on body composition, quality of life, inflammation, nutrition status, and gut microbiota?

Researchers will compare people who assume the AMBROSIA Bar in addition to nutritional counseling to those who only receive nutritional counseling.

Participants will:

* Receive nutritional counseling and consume one AMBROSIA Bar per day for 6 months (intervention group) or receive nutritional counseling only (control group). * Receive clinical assessment at the moment of enrolment, after 3 months, and after 6 months * Give samples (blood, saliva, urine, and stool) and complete questionnaires to check their nutrition, cognitive, and physical health

Eligibility criteria

Qualifiers

Age >70 years;

Caucasian ethnicity;

Diagnosis of atrial fibrillation (AF) and/or heart failure (HF);

Normal nutritional status or at risk of malnutrition;

Disqualifiers

Obesity (BMI >30 Kg/m2);

Underweight (BMI <18.5 Kg/m2);

Use of antibiotics, corticosteroids and immune-suppressors in the last 6 months;

Immunodeficiency;

Trial design

Treatments tested in this trial

  • Ambrosia bar

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Azienda Ospedaliero-Universitaria Careggi

Lead sponsor

University of Florence

Collaborator

Northumbria University

Collaborator

Synbiotec Srl

Collaborator

University College Dublin

Collaborator

Fundació d'investigació Sanitària de les Illes Balears

Collaborator