NCT07076329

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

Microbiota-Inflammation-Brain Axis in Heart Failure: New Food, biomarkerS and Artificial Intelligence Approach for the Prevention of undeRnutrition in Older

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Azienda Ospedaliero-Universitaria Careggi · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Atrial Fibrillation (AF)
• Heart Failure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ambrosia bar	The experimental intervention involves the "AMBROSIA" bar alongside healthy dietary counseling. The "AMBROSIA" bar is a novel chocolate bar designed for older Heart Failure (HF) and Atrial Fibrillation (AF) patients to prevent undernutrition. Its distinguishing features are: * Unique Composition: It contains a unique and specific blend of probiotic strains and a cocktail of micro/macronutrients. * Patented Probiotic Efficacy: The SYNBIO® blend is patented (RM2004A000166, EP1743042) for its exceptional intestinal mucosal adhesion, ensuring effective colonization and persistence. * Optimal Delivery Matrix: The chocolate bar serves as a palatable and effective vehicle for probiotic delivery, confirmed to maintain probiotic viability. * Targeted Nutritional Strategy: The bar aims to modulate gut microbiota and address undernutrition, inflammation, and cachexia in the target.

Timeline

• Start date: 2022-02-07
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2025-07-22
• Last updated: 2025-07-31

Locations

1 site across 1 country: Italy