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

Azienda Ospedaliero-Universitaria Careggi

Status: Enrolling

Conditions: Atrial Fibrillation (AF); Heart Failure

Treatments: Dietary Supplement: Ambrosia bar

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07076329

19882_spe

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Ambrosia group

Experimental group

Description:

Participants in the intervention group will receive the AMBROSIA Bar along with standard nutritional counselling. The AMBROSIA Bar is a functional chocolate-based food product designed specifically for older adults with heart failure and/or atrial fibrillation. It contains a tailored blend of ingredients, including: Probiotic strains (Lacticaseibacillus rhamnosus Istituto Microbiologico C. N. R.501® and Lacticaseibacillus paracasei Istituto Microbiologico C. N. R.502®, branded as SYNBIO®), Hydrolysed proteins, Inulin (a dietary fiber), Coenzyme Q10 Participants will consume one AMBROSIA Bar per day for 6 months. The formulation aims to support muscle health, improve nutrient absorption, modulate the gut microbiota, and reduce inflammation.

Treatment:

Dietary Supplement: Ambrosia bar

Control group

No Intervention group

Description:

Participants in the control group will receive standard nutritional counseling.