Microbiota-Inflammation-Brain Axis in Heart Failure: New Functional Food for the Preventio
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?
| Condition(s) | Atrial Fibrillation (AF), Heart Failure |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 ass |
| Who can participate | 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 infect |
| Ages | 70 Years |
| Sex | All |
| Lead sponsor | Azienda Ospedaliero-Universitaria Careggi |
| Locations | Florence, Italy |
| Start date | 2022-02-07 |
| NCT ID | NCT07076329 |
| Official listing | https://clinicaltrials.gov/study/NCT07076329 |