An interventional study of Ambrosia bar in Atrial Fibrillation (AF) and Heart Failure, sponsored by Azienda Ospedaliero-Universitaria Careggi. Recruiting at 1 site in Italy. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Azienda Ospedaliero-Universitaria Careggi · Not applicable, Interventional, and Prevention
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:
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 60 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Azienda Ospedaliero-Universitaria Careggi is the lead sponsor of 77 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants in the control group will receive standard nutritional counseling.
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.
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).
Time frame: From enrollment to the end of treatment at 6 months.
Changes to anthropometry
Weight (kg) and height (m) will be measured and used to calculate Body Mass Index (BMI, kg/m²). Each parameter will be analyzed separately.
Time frame: From enrollment to the end of treatment at 6 months.
Changes to body composition
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.
Time frame: From enrollment to the end of treatment at 6 months.
Impacts on Quality of Life associated with Bowel Function:
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..
Time frame: From enrollment to the end of treatment at 6 months.
Change in Geriatric Depression Scale (GDS-15) score
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.
Time frame: From enrollment to the end of treatment at 6 months.
Change in Mini-Mental State Examination (MMSE) score
The MMSE is a cognitive screening tool scored from 0 to 30. Higher scores indicate better cognitive function.
Time frame: From enrollment to the end of treatment at 6 months.
Change in handgrip strength
Measured using a hand dynamometer. Results expressed in kilograms (kg). Higher values indicate better muscle strength.
Time frame: From enrollment to the end of treatment at 6 months.
Change in Clinical Frailty Scale (CFS)
Assessed using the Clinical Frailty Scale, a 9-point scale (1 = very fit; 9 = terminally ill). Higher scores indicate worse frailty.
Time frame: From enrollment to the end of treatment at 6 months.
Impacts on the composition of the fecal microbiota
Evaluation of changes in the gut microbiota profile through 16s RNA targeted sequencing.
Time frame: From enrollment to the end of treatment at 6 months.
Changes to nutritional and inflammatory biomarkers in blood samples
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.
Time frame: From enrollment to the end of treatment at 6 months.
Changes to blood lipid profile
Modifications in the blood lipid profile, using gas chromatography techniques.
Time frame: From enrollment to the end of treatment at 6 months.
Modifications in metabolomic profiles in plasma, saliva, and stool samples.
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.
Time frame: From enrollment to the end of treatment at 6 months.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Feb 2022 (actual). Primary completion is estimated for Sep 2025, 43 months after the start.
Of 796 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 43 months is close to that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Azienda Ospedaliero-Universitaria Careggi