Clinical Trial

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

Study acronym: AMBROSIA
Recruiting
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Record status
This record was last updated July 31, 2025 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-17.
Trial Details
NCT Number NCT07076329
Lead Sponsor Azienda Ospedaliero-Universitaria Careggi
Collaborators: University of Florence, Northumbria University, Synbiotec Srl, University College Dublin, Fundació d'investigació Sanitària de les Illes Balears
Conditions Atrial Fibrillation (AF), Heart Failure
Enrollment 60 participants
Start Date 2022-02-07
Primary Completion 2025-09-30 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-31