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

NCT07076329 · tracked via the Priya Life Science Italy tracker

Sponsor

Azienda Ospedaliero-Universitaria Careggi

Phase

Not applicable

Started

2022-02-07

Last updated

2025-07-31

Condition(s) studied

Atrial Fibrillation (AF)Heart Failure

Investigational drug(s) / intervention(s)

Ambrosia bar

Ambrosia 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.

Study 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

Sex

ALL

Min age

70 Years

Max age

—

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

Primary outcome measure(s)

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).

Trial sites (1)

Facility	City	Region	Status
Azienda Ospedaliera Universitaria Careggi	Florence	Italy	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07076329 on ClinicalTrials.gov ↗ ← All trials in Italy