NCT04756856终止不适用
Impact of a Muscle-targeted Nutritional Therapy in the Recovery of Post-discharge COVID19 Patients Suffering From Sarcopenia
Fondazione IRCCS Policlinico San Matteo di Pavia2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2021年4月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Physical performance - chair-stand
研究概览
简要总结
To assess the impact of a muscle-targeted nutritional therapy consisting of nutritional counseling and high-quality whey protein-based oral nutritional supplements enriched with leucine and vitamin D, on the recovery of post-COVID-19 patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sarcopenia (revised European Working Group on Sarcopenia in Older People criteria)
- •Recent discharge from hospital for COVID-19
- •Informed consent
排除标准
- •Any malignant disease during the last five years
- •Known kidney failure (previous glomerular filtration rate <30 ml/min);
- •Known liver failure (Child B or C)
- •Psychiatric disease
- •Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
- •Indications related to the study product:
- •More than 10 µg (400 IU) of daily Vitamin D intake from medical sources. More than 500 mg of daily calcium intake from medical sources. Adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study.
- •Known allergy to milk, milk products or other components of the proposed interventions
- •Indication to or ongoing artificial nutrition support
- •Inclusion in other nutrition intervention trials
- •Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
结局指标
主要结局
Physical performance - chair-stand
时间窗: 12 weeks
Change in chair-stand test
次要结局
- Total body muscle mass(24 weeks)
- Appendicular muscle mass(24 weeks)
- Fatigue(24 weeks)
- Body weight(24 weeks)
- Functional status - muscle strength(24 weeks)
- Self-perceived quality of life(24 weeks)
- Serum levels of 25-hydroxy-vitamin D(24 weeks)
- Physical performance - chair-stand(24 weeks)
- Energy intake(24 weeks)
研究者
Emanuele Cereda
Principal investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
研究点 (2)
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