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

NCT07076329 | Recruiting

• 1 other identifier: 19882_spe
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation (AF); Heart Failure

Keywords

gut microbiota; elderly; probiotics; functional food; frailty; inflammation; heart failure; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Skeletal Muscle Mass 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).

  From enrollment to the end of treatment at 6 months.

Secondary Outcomes (11)

• Changes to anthropometry

  From enrollment to the end of treatment at 6 months.

• Changes to body composition

  From enrollment to the end of treatment at 6 months.

• Impacts on Quality of Life associated with Bowel Function:

  From enrollment to the end of treatment at 6 months.

• Change in Geriatric Depression Scale (GDS-15) score

  From enrollment to the end of treatment at 6 months.

• Change in Mini-Mental State Examination (MMSE) score

  From enrollment to the end of treatment at 6 months.

Study Arms (2)

Ambrosia group

EXPERIMENTAL

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.

Dietary Supplement: Ambrosia bar

Control group

NO INTERVENTION

Participants in the control group will receive standard nutritional counseling.

Interventions

Ambrosia bar DIETARY_SUPPLEMENT

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.

Ambrosia group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead
• University of Florence: collaborator
• Northumbria University: collaborator
• Synbiotec Srl: collaborator
• University College Dublin: collaborator
• Fundació d'investigació Sanitària de les Illes Balears: collaborator

Study Sites (1)

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure; Frailty; Inflammation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 22, 2025
• Study Start: February 7, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)