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
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