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

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation (AF); Heart Failure

• Registration Number: NCT07076329
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-07
• Study First Submitted: 2025-06-17
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in the Skeletal Muscle Mass at 6 months	From enrollment to the end of treatment at 6 months.	A change in skeletal muscle mass from baseline versus the control group as assessed by Bioelectrical Impedence Analysis, change in physical performance as evaluated with SHORT PHYSICAL PERFORMANCE BATTERY test, a measure of frailty).

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Nutritional and Clinical parameters at 6 months	From enrollment to the end of treatment at 6 months.	Other changes to body composition and anthropometry; Impacts on quality of life , disability and functionality; Impacts on the composition of the fecal microbiota.; Changes to inflammatory marker status in blood samples; Changes to blood lipid profile; Changes to blood markers of undernutrition (particularly albuminemia); Metabolomics screening of plasma, saliva and fecal samples to define potential markers of undernutrition and responsiveness to nutritional intervention.

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria Careggi; 🇮🇹 Firenze, Italy