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Recruiting NCT07076329

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

No phase Interventional Atrial Fibrillation (AF) Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ambrosia bar.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF), Heart Failure. Basic parameters: from 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Dietary supplement 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 exc

Primary outcome measures

  • Change from Baseline in the Skeletal Muscle Mass at 6 months [Time frame: From enrollment to the end of treatment at 6 months.]
Secondary outcome measures (11)
  • Changes to anthropometry [Time frame: From enrollment to the end of treatment at 6 months.]
  • Changes to body composition [Time frame: From enrollment to the end of treatment at 6 months.]
  • Impacts on Quality of Life associated with Bowel Function: [Time frame: From enrollment to the end of treatment at 6 months.]
  • Change in Geriatric Depression Scale (GDS-15) score [Time frame: From enrollment to the end of treatment at 6 months.]
  • Change in Mini-Mental State Examination (MMSE) score [Time frame: From enrollment to the end of treatment at 6 months.]
  • Change in handgrip strength [Time frame: From enrollment to the end of treatment at 6 months.]
  • Change in Clinical Frailty Scale (CFS) [Time frame: From enrollment to the end of treatment at 6 months.]
  • Impacts on the composition of the fecal microbiota [Time frame: From enrollment to the end of treatment at 6 months.]
  • Changes to nutritional and inflammatory biomarkers in blood samples [Time frame: From enrollment to the end of treatment at 6 months.]
  • Changes to blood lipid profile [Time frame: From enrollment to the end of treatment at 6 months.]
  • Modifications in metabolomic profiles in plasma, saliva, and stool samples. [Time frame: From enrollment to the end of treatment at 6 months.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Italy · 1 center
  • Azienda Ospedaliera Universitaria Careggi — Florence

Identifiers

NCT: NCT07076329 · 19882_spe

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗