RecruitingNot ApplicableNCT07076329

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

Sponsor

Azienda Ospedaliero-Universitaria Careggi

Enrollment

60 participants

Start Date

Feb 7, 2022

Study Type

INTERVENTIONAL

Conditions

Heart Failure Atrial Fibrillation (AF)

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 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

Eligibility

Min Age: 70 Years

Inclusion Criteria5

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 Criteria14

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

Interventions

DIETARY_SUPPLEMENTAmbrosia bar

The experimental intervention involves the "AMBROSIA" bar alongside healthy dietary counseling. The "AMBROSIA" bar is a novel chocolate bar designed for older Heart Failure (HF) and Atrial Fibrillation (AF) patients to prevent undernutrition. Its distinguishing features are: * Unique Composition: It contains a unique and specific blend of probiotic strains and a cocktail of micro/macronutrients. * Patented Probiotic Efficacy: The SYNBIO® blend is patented (RM2004A000166, EP1743042) for its exceptional intestinal mucosal adhesion, ensuring effective colonization and persistence. * Optimal Delivery Matrix: The chocolate bar serves as a palatable and effective vehicle for probiotic delivery, confirmed to maintain probiotic viability. * Targeted Nutritional Strategy: The bar aims to modulate gut microbiota and address undernutrition, inflammation, and cachexia in the target.