Nutritional Support With Mediterranean Diet and Hyper Caloric, Hyperproteic Oral Supplements in Heart Failure Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Left ventricular ejection fraction
研究概览
简要总结
Heart failure (HF) is a chronic disease with an increasing incidence; it represents the final stage of multiple cardiac diseases and significantly affects the QoL of the patients. Its prevalence is about 26 million people in the world, especially in elderly. Sarcopenia has been directly associated with the presence of increased comorbidity in patients with HF. In this study the investigators aim to compare the clinical evolution of patients with HF after receiving nutritional support with Mediterranean diet alone or in combination with a hypercaloric, hyperproteic oral nutritional Supplement
详细描述
All participants will receive general counseling, education about MedDiet and vitamin D supplementation in order to reach levels of sufficiency (25OH vitamin D>30 ng/dL) for avoiding confounding results. Participants (n=50) will be randomly allocated to MedDiet or MedDiet plus hypercaloric, hyperproteic standard oral nutritional supplement (ONS), 2 ONS per da). Participants will be evaluated at baseline, 12 and 24 weeks after nutritional support
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients with a previous admission due to HF in the previous 12 months
- •Moderate or severe LVEF
- •Both sexs
- •Age >18 years old.
排除标准
- •MDRD <15 ml/min
- •End-stage liver disease.
结局指标
主要结局
Left ventricular ejection fraction
时间窗: 6 months
Changes in left ventricular ejection fraction
Muscle mass
时间窗: 6 months
Changes in percent of muscle mass
次要结局
- Albumin(6 months)
- Preallbumin(6 months)
- pro-BNP(6 months)
- Transferrin(6 months)
- CRP(6 months)
- Phase angle(6 months)
- Fat mass(6 months)