NCT02683720Unknown不适用
Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- lean body mass
研究概览
简要总结
ProMO aims to investigate the effectiveness of a newly developed ONS in increasing body weight, muscle mass and function in malnourished elderly compared to standard care.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at risk of malnutrition/ malnourished
排除标准
- •• Mental status that is incompatible with the proper conduct of the study
- •Illness of such severity that life expectancy is considered to be less than 12 months
- •Use of diabetes medication (e.g. insulin, methformin)
- •Use of an oral nutritional supplement in the previous three months
- •Participating in any regular exercise training program (≥2h/w)
- •Renal insufficiency (eGFR <30 mL/min/1.73 m2)
- •Unstable organ failure or organ failure necessitating a special diet
- •Chronic corticosteroids use
- •Recent (previous 2 months) use of antibiotics
- •Recent (previous 3 months) change in habitual medication use (e.g statins and thyroxin)
- •Recent blood donation (<1 month prior to Day 01 of the study)
- •Not willing or afraid to give blood during the study
- •Allergic or sensitive for milk proteins
- •Reported vegan or macrobiotic life-style
- •Drug and/or alcohol abuse (current consumption of more than 21 alcoholic drinks per week)
- •Individual unable to give informed consent
- •Current participation in other research from the Division of Human Nutrition
- •Not having a general practitioner
- •Personnel of Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives
结局指标
主要结局
lean body mass
时间窗: 12 weeks
次要结局
- body weight(12 weeks)
研究者
Lisette de Groot
MSc PhD Prof
Wageningen University
研究点 (1)
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