Atrial Fibrillation (AF)AMBROSIANCT07076329
Microbiota-Inflammation-Brain Axis in Heart Failure: New Functional Food for the Prevention of undeRnutrition in Older
A study testing Ambrosia bar in people with Atrial Fibrillation (AF) and Heart Failure, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Heart Failure
- What is being tested?
- Ambrosia bar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 7 Feb 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Careggi
Florence
Stefano Fumagalli, 0552751821, stefano.fumagalli@unifi.it
About this study
Official title: Microbiota-Inflammation-Brain Axis in Heart Failure: New Food, biomarkerS and Artificial Intelligence Approach 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:
Read more
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
- Being tested
- Ambrosia bar
- Keywords
- gut microbiota, elderly, probiotics, functional food, frailty, inflammation, heart failure, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation, Heart Failure, Frailty, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambrosia barDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Ambrosia bar |
| Control group | No intervention | Participants in the control group will receive standard nutritional counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of treatment at 6 months.
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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..
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start7 Feb 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florence, Northumbria University, Synbiotec Srl, University College Dublin, Fundació d'investigació Sanitària de les Illes Balears
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076329
- Sponsor's protocol ID
- 19882_spe
- Acronym
- AMBROSIA
- Status last verified
- Jul 2025
- First submitted
- 17 Jun 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota-Inflammation-Brain Axis in Heart Failure: New Food, biomarkerS and Artificial Intelligence Approach for the Prevention of undeRnutrition in Older
- ClinicalTrials.gov ID
- NCT07076329
- Acronym / sponsor ID
- AMBROSIA / 19882_spe
- Conditions
- Atrial Fibrillation (AF), Heart Failure
- Keywords
- gut microbiota, elderly, probiotics, functional food, frailty, inflammation, heart failure, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Collaborators
- University of Florence, Northumbria University, Synbiotec Srl, University College Dublin, Fundació d'investigació Sanitària de les Illes Balears
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambrosia group | Experimental | Dietary Supplement: Ambrosia barParticipants 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. |
| Control group | No intervention | –Participants in the control group will receive standard nutritional counseling. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambrosia barThe 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. | Dietary supplement | Ambrosia group |
Primary outcome
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).
11 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambrosia bar in people with Atrial Fibrillation (AF) and Heart Failure, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Skeletal Muscle Mass at 6 months (time frame: From enrollment to the end of treatment at 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.