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NCT Number: NCT07076329

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

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

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Frailty Heart Diseases Heart Failure Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Location status: Recruiting

Location contact

Stefano Fumagalli

CONTACT

[email protected]

0552751821

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change from Baseline in the Skeletal Muscle Mass at 6 months

    Time frame: 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 outcomes

  1. Changes to anthropometry

    Time frame: From enrollment to the end of treatment at 6 months.

    Weight (kg) and height (m) will be measured and used to calculate Body Mass Index (BMI, kg/m²). Each parameter will be analyzed separately.

  2. Changes to body composition

    Time frame: From enrollment to the end of treatment at 6 months.

    Change in body composition assessed by Bioelectrical Impedance Analysis (BIA): Fat Mass (FM, kg), Fat Free Mass (FFM, kg), and Body Cell Mass (BCM, kg). In addition, FFM will be combined with height (m) to calculate Fat-Free Mass Index (FFMI, kg/m²). Each parameter will be reported and analyzed separately.

  3. Impacts on Quality of Life associated with Bowel Function:

    Time frame: From enrollment to the end of treatment at 6 months.

    Changes in quality of life assessed by Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a validated 36-item questionnaire measuring gastrointestinal-specific quality of life. Scores range from 0 to 144. Higher scores indicate better quality of life..

  4. Change in Geriatric Depression Scale (GDS-15) score

    Time frame: From enrollment to the end of treatment at 6 months.

    The GDS-15 is a self-report screening tool for depression in older adults. Scores range from 0 to 15; higher scores indicate more severe depressive symptoms.

  5. Change in Mini-Mental State Examination (MMSE) score

    Time frame: From enrollment to the end of treatment at 6 months.

    The MMSE is a cognitive screening tool scored from 0 to 30. Higher scores indicate better cognitive function.

  6. Change in handgrip strength

    Time frame: From enrollment to the end of treatment at 6 months.

    Measured using a hand dynamometer. Results expressed in kilograms (kg). Higher values indicate better muscle strength.

  7. Change in Clinical Frailty Scale (CFS)

    Time frame: From enrollment to the end of treatment at 6 months.

    Assessed using the Clinical Frailty Scale, a 9-point scale (1 = very fit; 9 = terminally ill). Higher scores indicate worse frailty.

  8. Impacts on the composition of the fecal microbiota

    Time frame: From enrollment to the end of treatment at 6 months.

    Evaluation of changes in the gut microbiota profile through 16s RNA targeted sequencing.

  9. Changes to nutritional and inflammatory biomarkers in blood samples

    Time frame: From enrollment to the end of treatment at 6 months.

    Changes in circulating inflammatory markers, mainly plasma cytokine profiles, and blood markers of undernutrition, using the immunoassays based on Luminex xMAP (multi-analyte profiling) technology which enable simultaneous detection and quantification of multiple secreted proteins.

  10. Changes to blood lipid profile

    Time frame: From enrollment to the end of treatment at 6 months.

    Modifications in the blood lipid profile, using gas chromatography techniques.

  11. Modifications in metabolomic profiles in plasma, saliva, and stool samples.

    Time frame: From enrollment to the end of treatment at 6 months.

    Metabolite profiles of plasma, urine and faecal water in all samples will be generated through reverse phase (plasma) and hydrophilic interaction (urine, faecal water) chromatography, in order to define potential markers of undernutrition and responsiveness to nutritional intervention.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Collaborators

  • Fundació d'investigació Sanitària de les Illes Balears
  • Northumbria University
  • Synbiotec Srl
  • University College Dublin
  • University of Florence

Registry information

Official study title

Microbiota-Inflammation-Brain Axis in Heart Failure: New Food, biomarkerS and Artificial Intelligence Approach for the Prevention of undeRnutrition in Older

Acronym: AMBROSIA

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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