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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Azienda Ospedaliera Universitaria Careggi
  Florence, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.