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| Name | Class |
|---|---|
| University of Florence | OTHER |
| Northumbria University | OTHER |
| Synbiotec Srl | INDUSTRY |
| University College Dublin |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control group | No Intervention | Participants in the control group will receive standard nutritional counseling. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 6 months. |
| Changes to body composition |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Universitaria Careggi | Recruiting | Florence | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Apr 19, 2021 | Jul 1, 2025 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006333 | Heart Failure |
| D000073496 | Frailty |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| OTHER |
| Fundació d'investigació Sanitària de les Illes Balears | OTHER_GOV |
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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.
| 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.. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From enrollment to the end of treatment at 6 months. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |