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Microbiota-Inflammation-Brain Axis in Heart Failure: New Functional Food for the Prevention of undeRnutrition in Older

RecruitingNAAges 70 Years - anyAllAzienda Ospedaliero-Universitaria Careggi
NCT07076329 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, s

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📋 Eligibility rules (as published)
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
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What it tests

  • Ambrosia bar
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Where

1 site
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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