NCT02404987Unknown不适用
A Prospective, Observational Study, of a High Calorie and Protein Oral Nutritional Supplement, in an Older Malnourished Spanish Population
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Body Weight
研究概览
简要总结
Post-marketing observational study of a nutritional care plan, including a higher calorie, higher protein oral nutritional supplement (ONS), prescribed to Spanish patients, both free living and residing and nursing homes, who have been identified as malnourished. The objective is to assess the impact of the ONS on body weight, activities of daily living and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any participation in the study.
- •Considered malnourished, or is at risk for malnutrition based on NRS 2002 score ≥
- •≥65 years of age.
- •Conforms to the requirements set forth on the study product label.
- •Under the care of a health care professional for malnutrition and has recently (within the last 7 days prior to participating in this study) been prescribed 2 servings/d of the study ONS, orally, by their health care professional.
- •Free living or residing in a nursing home.
- •Estimated, or measured, glomerular filtration rate >60ml/min/1.73m2 (Modification of Diet in Renal Disease (MDRD) Study equation) within 60 days of beginning their nutritional care plan.
- •Body mass index (BMI) is <30 kg/m
- •Study physician determines the subject is fit to participate.
排除标准
- 未提供
结局指标
主要结局
Body Weight
时间窗: Change from baseline to 12 weeks
次要结局
- Body Mass Index (BMI)(Change from baseline to 12 weeks)
- Katz Activities of Daily Living(Change from baseline to 12 weeks)
- Quality of Life(Change from baseline to 12 weeks)
研究者
研究点 (1)
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