NCT01902212已完成不适用
Evaluation of an Oral Nutrition Supplement
适应症
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 capture gastrointestinal tolerance (GI) information on a nutrient dense oral nutritional supplement (ONS) in healthy elderly subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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:
- •Male or female ≥ 60 and ≤ 90 years of age.
- •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
- •Antibiotic use within 1 week prior to enrollment
- •Undergone major surgery less than 3 months prior to enrollment.
- •Current active malignant disease or was treated within the last 6 months for cancer.
- •Immunodeficiency disorder.
- •Myocardial infarction within the last 3 months.
- •Chronic obstructive pulmonary disease (COPD).
- •Allergy to any of the ingredients in the study product.
- •Obstruction of the gastrointestinal tract or other major gastrointestinal disease.
- •Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder.
- •Unintentional weight loss or weight gain ≥ 5% in last 4 weeks.
- •Taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect GI motility.
结局指标
主要结局
Gastro-Intestinal Tolerance
时间窗: Study Day (SD) 1-8
Subject questionnaire
次要结局
- ONS Consumption(SD 1-8)
- Weight(Screening and SD 8)
研究者
研究点 (2)
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