NCT01781624已完成不适用
Evaluation of an Oral Nutritional Supplement With a New Protein Blend
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Gastro-Intestinal Tolerance
研究概览
简要总结
The objective of this study is to evaluate gastrointestinal tolerance of an oral nutritional supplement containing a new protein blend in healthy elderly subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be eligible for the study if they meet all of the following inclusion criteria:
- •Age ≥ 60 and ≤ 90 years
- •Body Mass Index (BMI) > 20 but < 35
排除标准
- •Subjects will be excluded from the study if they meet any of the following criteria:
- •History of diabetes
- •Currently taking or has taken antibiotic within 1 week prior to enrollment
- •Major surgery less than 3 months prior to enrollment in the study
- •Current active malignant disease or was treated within the last 6 months for cancer
- •Immunodeficiency disorder
- •Myocardial infarction within the last 3 months prior to enrollment
- •Chronic obstructive pulmonary disease (COPD)
- •Allergy to any of the ingredients in the study product
- •Aversion to flavor of product being tested
- •Obstruction of the gastrointestinal tract precluding ingestion or absorption of the study product, inflammatory bowel disease, ulcer, gastric reflux disease, short bowel syndrome, or other major gastrointestinal disease
- •Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder
- •Pursuing or has unintentional weight loss or weight gain ≥ 5% in last 4 weeks
- •Medications/dietary supplements/substances that could profoundly modulate metabolism or affect GI motility
研究组 & 干预措施
Study Oral Nutritional Supplement
Experimental
2 containers a day of a high calorie, complete, balanced, ready-to-drink oral nutritional supplement with a new protein blend.
干预措施: Study Oral Nutritional Supplement (Other)
结局指标
主要结局
Gastro-Intestinal Tolerance
时间窗: Study Day 1-7
Self-reported questionnaire
次要结局
- Weight(Study Day 1 and 8)
- Study Product Compliance(Study Day 1-7)
研究者
研究点 (2)
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