Daily AMBROSIA nutritional bar to prevent undernutrition and muscle loss in older adults with AF or heart failure

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

This trial will try a daily AMBROSIA functional food plus nutritional counseling to see if it prevents undernutrition and muscle loss in people over 70 with atrial fibrillation or heart failure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 70 Years and up
• Sex: All
• Sponsor: Azienda Ospedaliero-Universitaria Careggi (Academic / other)
• Locations: 1 site (Florence)
• Trial ID: NCT07076329 on ClinicalTrials.gov

What this trial studies

Older adults with atrial fibrillation or heart failure who are not obese or underweight and who follow a Mediterranean diet will be assigned to either take one AMBROSIA bar per day plus nutritional counseling or receive nutritional counseling alone for six months. Clinical visits occur at enrollment, three months, and six months, with collection of blood, saliva, urine, and stool samples and questionnaires on nutrition, cognition, and physical function. Primary measurements include muscle mass and physical performance, and secondary outcomes include body composition, quality of life, inflammation markers, nutritional status, and gut microbiota changes. The trial compares the two groups over time to see whether adding the functional bar produces measurable benefits.

Who should consider this trial

Good fit: Ideal candidates are adults older than 70 with atrial fibrillation and/or heart failure who are Caucasian, not obese or underweight, at normal nutritional status or at risk of malnutrition, and adherent to a Mediterranean diet.

Not a fit: People with obesity or underweight, recent antibiotic or immunosuppressive use, uncontrolled diabetes, active cancer, severe liver or kidney disease, dementia, recent major surgery, chronic NSAID use, or significant allergies are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If successful, the AMBROSIA bar could help preserve muscle mass, improve physical performance, and reduce undernutrition in older people with heart conditions.

How similar studies have performed: Some small trials and pilot studies of probiotics, protein-enriched foods, or other functional foods have shown modest improvements in inflammation or muscle-related outcomes, but large definitive trials in older cardiac patients are limited.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* Obesity (BMI \>30 Kg/m2);
* Underweight (BMI \<18.5 Kg/m2);
* Use of antibiotics, corticosteroids and immune-suppressors in the last 6 months;
* Immunodeficiency;
* Trip to exotic areas in the last 12 months;
* Recent (\<3 months) major surgical procedure;
* Uncontrolled diabetes mellitus;
* Active cancer;
* Chronic significant hepatic diseases;
* Chronic renal failure (KDIGO stages 4-5);
* Dementia and severe mental diseases;
* Other conditions interfering with autonomous drugs assumption;
* Chronic use of NSAIDs;
* Relevant history of allergy or infectious diseases

Where this trial is running

Florence

• Azienda Ospedaliera Universitaria Careggi — Florence, Italy (Recruiting)

Conditions Atrial Fibrillation; Heart Failure; gut microbiota; elderly; probiotics; functional food; frailty; inflammation