Actively Recruiting
Microbiota-Inflammation-Brain Axis in Heart Failure: New Functional Food for the Prevention of undeRnutrition in Older
Led by Azienda Ospedaliero-Universitaria Careggi · Updated on 2025-07-31
60
Participants Needed
1
Research Sites
190 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliero-Universitaria Careggi
Lead Sponsor
U
University of Florence
Collaborating Sponsor
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Microbiota-Inflammation-Brain Axis in Heart Failure: New Functional Food for the Prevention of undeRnutrition in Older
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here