Microbiota-Inflammation-Brain Axis in Heart Failure: New Functional Food for the Prevention of un… (NCT07076329) | Clinical Trial Compass
RecruitingNot Applicable
Microbiota-Inflammation-Brain Axis in Heart Failure: New Functional Food for the Prevention of undeRnutrition in Older
Italy60 participantsStarted 2022-02-07
Plain-language 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
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in the Skeletal Muscle Mass at 6 months
Timeframe: From enrollment to the end of treatment at 6 months.