NCT01191125已完成3 期
Evaluation of an Oral Nutritional Supplement Containing AN777 in Malnourished and Frail Subjects
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 331
- 试验地点
- 23
- 主要终点
- Knee extensor strength
研究概览
简要总结
To evaluate the effect of an experimental oral nutritional supplement containing AN777 compared to another oral nutritional supplement in a malnourished, elderly population.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject (male or female) is > or equal to 65 and < or equal to 90 years of age
- •Subject is ambulatory
- •Subject has a Subjective Global Assessment of B or C
- •Subject has gait speed <0.8 m/s AND/OR low hand-grip strength
- •Subject has Class 1 or Class 2 sarcopenia
- •Subject agrees to refrain from starting a resistance exercise program
排除标准
- •Subject has type 1 or type 2 diabetes
- •Subject has inflammatory disease with elevated high sensitivity C-reactive protein
- •Subject has renal function impairment
- •Subject reports gastrointestinal disorder (severe chronic diarrhea, nausea, vomiting) that would preclude ingestion of the study product; an obstruction of the gastrointestinal tract, inflammatory bowel disease; short bowel syndrome or other major gastrointestinal disease
- •Subject reports of current active malignant disease or other significant medical diagnoses.
- •Subject reports a history of allergy to any of the ingredients in the study products
- •Subject reports currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or weight.
研究组 & 干预措施
oral nutritional formula
Active Comparator
干预措施: oral nutritional formula (Other)
medical food with AN777
Experimental
干预措施: medical food with AN777 (Other)
结局指标
主要结局
Knee extensor strength
时间窗: Six months
次要结局
- Leg muscle mass(Six months)
- Body Weight(Six months)
- Functional measures(Six months)
研究者
研究点 (23)
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