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

Study acronym: AMBROSIA
StatusRecruiting
PhaseNot applicable
Started
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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.

Record History

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  1. Secondary endpoints: 1 to 11v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
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
(from sponsor)		 Atrial Fibrillation (AF), Heart Failure
Related terms Atrial Fibrillation, Frailty, Heart Failure, Inflammation
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov