NCT07076329Recruiting
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
Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 17 Jun 2025
- Start date
- 7 Feb 2022
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT07076329
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 7 Feb 2022 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antibiotics, corticosteroids and immune-suppressors in the last 6 months;
- Recent (\<3 months) major surgical procedure;
Other illness
- 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
Other
- 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;
Who the study is looking for
- 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
Age in the registry: 70 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliera Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.