NCT07076329 Microbiota-Inflammation-Brain Axis in Heart Failure: New Functional Food for the Prevention of undeRnutrition in Older
| NCT ID | NCT07076329 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliero-Universitaria Careggi |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-02-07 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-02-07 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
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
Frequently Asked Questions
Who can join the NCT07076329 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07076329 currently recruiting?
Yes, NCT07076329 is actively recruiting participants. Visit ClinicalTrials.gov or contact Azienda Ospedaliero-Universitaria Careggi to inquire about joining.
Where is the NCT07076329 trial being conducted?
This trial is being conducted at Florence, Italy.
Who is sponsoring the NCT07076329 clinical trial?
NCT07076329 is sponsored by Azienda Ospedaliero-Universitaria Careggi. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.