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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:

• Age \>70 years;

• Caucasian ethnicity;

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

• Normal nutritional status or at risk of malnutrition;

• Adherence to Mediterranean diet

Locations
Other Locations
Italy
Azienda Ospedaliera Universitaria Careggi
RECRUITING
Florence
Time Frame
Start Date: 2022-02-07
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 60
Treatments
Experimental: Ambrosia group
Participants in the intervention group will receive the AMBROSIA Bar along with standard nutritional counselling. The AMBROSIA Bar is a functional chocolate-based food product designed specifically for older adults with heart failure and/or atrial fibrillation. It contains a tailored blend of ingredients, including:~Probiotic strains (Lacticaseibacillus rhamnosus Istituto Microbiologico C. N. R.501® and Lacticaseibacillus paracasei Istituto Microbiologico C. N. R.502®, branded as SYNBIO®), Hydrolysed proteins, Inulin (a dietary fiber), Coenzyme Q10~Participants will consume one AMBROSIA Bar per day for 6 months. The formulation aims to support muscle health, improve nutrient absorption, modulate the gut microbiota, and reduce inflammation.
No_intervention: Control group
Participants in the control group will receive standard nutritional counseling.
Sponsors
Collaborators: Northumbria University, Synbiotec Srl, Fundació d'investigació Sanitària de les Illes Balears, University of Florence, University College Dublin
Leads: Azienda Ospedaliero-Universitaria Careggi

This content was sourced from clinicaltrials.gov