NCT04702087Unknown不适用
Randomized, Placebo-controlled Clinical Study to Evaluate the Effect of 2 Months of Nutritional Support Based on Omega 3, Leucine, Probiotic Lactobacillus Paracasei PS23 (OLEP Study) on Muscle Mass in Sarcopenic Subjects
Azienda di Servizi alla Persona di Pavia2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2021年1月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Changes on muscle mass
研究概览
简要总结
The purpose of the study is to evaluate the effect of supplementation with a nutritional blend based on Omega 3 fatty acids, the probiotic leucine Lactobacillus paracasei PS23 (OLEP), on muscle mass recovery in sarcopenic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sarcopenic patients (diagnosis made according to the criteria Revised European Consensus on Definition and Diagnosis)
- •Body Mass Index between 20 and 30 Kg/m2
排除标准
- •severe renal failure (glomerular filtration rate < 30 mL/min)
- •moderate to severe liver failure (Child-Pugh class B or C)
- •endocrine diseases associated with calcium metabolism disorders (except osteoporosis)
- •known psychiatric disorders
- •cancer (over the past 5 years)
- •hypersensitivity to any component of the investigational nutritional supplement and
- •taking to protein/amino acid supplements (up to 3 months before starting the study)
- •patients unable to take oral therapy
- •receiving or with indication for artificial nutrition
- •who had been included in another clinical nutrition trial
结局指标
主要结局
Changes on muscle mass
时间窗: Baseline / 30 days / 60 days
Evaluation of fat free mass (g)
次要结局
- Changes on body composition(Baseline / 30 days / 60 days)
- Changes on muscle strength(Baseline / 30 days / 60 days)
- Changes on mood(Baseline / 60 days)
- Changes on plasma free essential amino acids(Baseline / 60 days)
- Changes on safety parameters(Baseline / 60 days)
- Changes on Quality of life(Baseline / 60 days)
- Changes on physical performancy(Baseline / 60 days)
- Changes on blood pressure(Baseline / 60 days)
- Changes on functional status(Baseline / 60 days)
研究者
研究点 (2)
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