Ambrosia food bar and poor nutrition in older people with heart failure
Tests the Ambrosia bar in older people with heart failure.
Plain-language title generated from the registry record
Registry title: Microbiota-Inflammation-Brain Axis in Heart Failure: New Functional Food for the Prevention of undeRnutrition in Older
Key facts
- Where
- Florence, ItalySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for older adults with atrial fibrillation and/or heart failure who have normal nutrition or are at risk of malnutrition. It tests a food bar plus nutritional counseling.
- Age
- Older than 70 years
- Sex
- All sexes can join
- Disease stage
- Diagnosis of atrial fibrillation (AF) and/or heart failure (HF). Normal nutritional status or at risk of malnutrition.
- Earlier treatment
- No antibiotics, corticosteroids or immune-suppressors in the last 6 months.
Main reasons for not taking part
- Obesity (BMI >30 Kg/m2) or underweight (BMI <18.5 Kg/m2)
- Immunodeficiency, active cancer or dementia
- Uncontrolled diabetes, chronic significant liver disease, or chronic renal failure (KDIGO stages 4-5)
- Major surgery in the last 3 months
- Trip to exotic areas in the last 12 months
Read by machine on 12 November 2026.
Where in Italy
- Azienda Ospedaliera Universitaria CareggiFlorence, ItalyContact: Stefano FumagalliTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Azienda Ospedaliero-Universitaria Careggi
- Trial code
- NCT07076329
- Record updated
- 31 July 2025
- Original description
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.Read full original descriptionShow less
Microbiota-Inflammation-Brain Axis in Heart Failure: New Food, biomarkerS and Artificial Intelligence Approach for the Prevention of undeRnutrition in Older
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
Inclusion: 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: Use of antibiotics, corticosteroids and immune-suppressors in the last 6 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; Relevant history of allergy or infectious diseases; Obesity (BMI >30 Kg/m2); Underweight (BMI <18.5 Kg/m2); Immunodeficiency; Trip to exotic areas in the last 12 months; Chronic use of NSAIDs.