Microbiota-Inflammation-Brain Axis in Heart Failure: New Functional Food for the Prevention of undeRnutrition in Older

Официальное название

Microbiota-Inflammation-Brain Axis in Heart Failure: New Food, biomarkerS and Artificial Intelligence Approach for the Prevention of undeRnutrition in Older

Обзор

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

Вмешательства

• Пищевая добавка Ambrosia bar
  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 exc

Первичные конечные точки

• Change from Baseline in the Skeletal Muscle Mass at 6 months [Срок оценки: From enrollment to the end of treatment at 6 months.]

Вторичные конечные точки (11)

• Changes to anthropometry [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Changes to body composition [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Impacts on Quality of Life associated with Bowel Function: [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Change in Geriatric Depression Scale (GDS-15) score [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Change in Mini-Mental State Examination (MMSE) score [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Change in handgrip strength [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Change in Clinical Frailty Scale (CFS) [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Impacts on the composition of the fecal microbiota [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Changes to nutritional and inflammatory biomarkers in blood samples [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Changes to blood lipid profile [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Modifications in metabolomic profiles in plasma, saliva, and stool samples. [Срок оценки: From enrollment to the end of treatment at 6 months.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Италия · 1 центр

• Azienda Ospedaliera Universitaria Careggi — Florence

Идентификаторы

NCT: NCT07076329 · 19882_spe

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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