Microbiota-Inflammation-Brain Axis in Heart Failure: New Food, biomarkerS and Artificial Intelligence Approach for the Prevention of undeRnutrition in Older
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline in the Skeletal Muscle Mass at 6 months
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ambrosia group
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.
干预措施: Ambrosia bar (Dietary Supplement)
Control group
Participants in the control group will receive standard nutritional counseling.
结局指标
主要结局
Change from Baseline in the Skeletal Muscle Mass at 6 months
时间窗: 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).
次要结局
- Change in Geriatric Depression Scale (GDS-15) score(From enrollment to the end of treatment at 6 months.)
- Changes to blood lipid profile(From enrollment to the end of treatment at 6 months.)
- Change in Mini-Mental State Examination (MMSE) score(From enrollment to the end of treatment at 6 months.)
- Change in handgrip strength(From enrollment to the end of treatment at 6 months.)
- Changes to anthropometry(From enrollment to the end of treatment at 6 months.)
- Changes to body composition(From enrollment to the end of treatment at 6 months.)
- Impacts on Quality of Life associated with Bowel Function:(From enrollment to the end of treatment at 6 months.)
- Change in Geriatric Depression Scale (GDS-15) score(From enrollment to the end of treatment at 6 months.)
- Change in Clinical Frailty Scale (CFS)(From enrollment to the end of treatment at 6 months.)
- Changes to nutritional and inflammatory biomarkers in blood samples(From enrollment to the end of treatment at 6 months.)
- Changes to anthropometry(From enrollment to the end of treatment at 6 months.)
- Changes to body composition(From enrollment to the end of treatment at 6 months.)
- Impacts on Quality of Life associated with Bowel Function:(From enrollment to the end of treatment at 6 months.)
- Change in Mini-Mental State Examination (MMSE) score(From enrollment to the end of treatment at 6 months.)
- Change in handgrip strength(From enrollment to the end of treatment at 6 months.)
- Change in Clinical Frailty Scale (CFS)(From enrollment to the end of treatment at 6 months.)
- Impacts on the composition of the fecal microbiota(From enrollment to the end of treatment at 6 months.)
- Changes to nutritional and inflammatory biomarkers in blood samples(From enrollment to the end of treatment at 6 months.)
- Modifications in metabolomic profiles in plasma, saliva, and stool samples.(From enrollment to the end of treatment at 6 months.)