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Prevention study for Atrial Fibrillation (AF)
Official title Microbiota-Inflammation-Brain Axis in Heart Failure: New Functional Food for the Prevention of undeRnutrition in Older
ClinicalTrials.gov ID: NCT07076329
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older
You may be able to join if
- 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
You likely can't join if
- 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;
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Florence, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Florence, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.