NCT01477723终止3 期
Evaluation of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 14
- 主要终点
- Leg Lean Mass
研究概览
简要总结
Study objectives are to verify the loss of lean mass during a hospital stay in a group of older patients; to evaluate the effects of consuming a high-calorie complete and balanced oral nutritional supplement; to collect post-discharge information.
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
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 55 years of age.
- •Admitted to hospital with a disease of respiratory system including acute respiratory diseases (e.g., pneumonia, acute bronchitis) or exacerbation of existing respiratory diseases.
- •Anticipated length of hospital stay of at least 3 days.
- •Ability to climb a flight of 10 stairs or walk a city block without the help of another person prior to hospitalization.
- •Able to consume foods and beverages orally.
排除标准
- •Unstable heart failure which requires ICU admission.
- •Severe respiratory disease requiring long-term, continuous oxygen therapy.
- •Impaired renal function.
- •Impaired liver function.
- •Hospitalized for two or more days in past 4 weeks.
- •Requires intubation or tube feeding.
- •Expected to be transferred to an advanced care unit.
- •Body mass index of ≥ 40 kg/m
- •Active tuberculosis.
- •Ascites or severe edema.
- •Acute Hepatitis or HIV.
- •Disorder of gastrointestinal tract.
- •Dementia;brain metastases, eating disorder, significant neurological, psychiatric disorder, other psychological condition.
- •Medication/dietary supplements/substances that could modulate metabolism or weight.
- •Partial or full artificial lower limb.
- •Allergy or intolerance to any of the ingredients in the study products.
- •Procedure using iodine-based contrast media within 7 days prior to hospitalization; or, anticipated to need procedure using iodine-based contrast media within 3 days after hospital admission.
研究组 & 干预措施
No Product
No Intervention
Experimental Oral Nutrition Supplement
Experimental
Experimental ONS orally Two 8 fl oz servings/day
干预措施: Experimental Oral Nutritional Supplement (Other)
结局指标
主要结局
Leg Lean Mass
时间窗: baseline to day 30
次要结局
- Body Weight(baseline to day 30)
- Body Mass Index(baseline to day 30)
- Activities of daily living(baseline to day 30)
研究者
研究点 (14)
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