NCT02698540已完成不适用
A Prospective, Observational Study, of a High Calorie, Higher Protein Peptide Based Oral Nutrition Supplement (ONS) With Medium Chain Triglycerides (MCTs) in a Malnourished Population With GI Tolerance Impairment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 23
- 主要终点
- Study Product Compliance
研究概览
简要总结
The purpose is to observe the compliance to a high-calorie, high protein peptide-based nutritional supplement after 3 months in a malnourished population with impaired gastrointestinal tolerance living in nursing homes and as outpatients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is considered malnourished, or is at risk for malnutrition based on MUST score ≥
- •Subject is ≥18 years old.
- •Subject has a condition that would benefit from a high calorie, higher protein ONS for GI tolerance impairment (e.g., diarrhea, nausea, vomiting, satiety or bloating).
- •Subject conforms to the requirements set forth on the study product label.
- •Subject is 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/day of the study ONS. Subject must have been naïve to ONS for GI tolerance impairment prior to being prescribed the study ONS.
排除标准
- •The study physician determines the subject is not fit to participate
- •Subject cannot provide informed consent to participate in the study.
- •Subject cannot safely consume the oral nutritional supplement.
- •Renal or liver failure (GFR< 60 ml/min or AST/ALTx3 normal) upper limit.
- •Type 1 or type 2 diabetes.
结局指标
主要结局
Study Product Compliance
时间窗: Baseline to Week 12
Subject reported diaries
次要结局
- Nutrition Status(Baseline to Week 12)
- Quality of Life(Baseline to Week 12)
- Body Weight(Baseline to Week 12)
- Gastrointestinal Tolerance(Baseline to Week 12)
- Body Mass Index(Baseline to Week 12)
研究者
研究点 (23)
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