A Study to Evaluate the Gastrointestinal Tolerance and Acceptability of a High Energy, High Protein Low Volume Oral Nutritional Supplement in Adult Patients With or at Risk of Malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- Gastro-Intestinal Tolerance
研究概览
简要总结
The purpose of this study is to evaluate the GI tolerance, palatability and compliance to a high protein energy-dense oral nutrition supplement in adult patients with or at risk of malnutrition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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 has voluntarily signed and dated informed consent form approved by Independent Ethics Committee and provided applicable privacy authorization prior to any participation in the study.
- •Subject is considered malnourished or at risk for malnutrition
- •Subject has normal GI function
- •Subject requires oral nutritional supplementation ands is willing to comply with the study protocol
排除标准
- •Subject has severe dementia, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
- •Subject has a history of diabetes
- •Subject is currently taking antibiotics or has taken antibiotics within 1 week prior to enrollment
- •Subject has undergone major GI surgery less than 3 months prior to enrollment
- •Subject has active malignant disease or was treated within the last 6 months for cancer
- •Subject has immunodeficiency disorder
- •Subject has had a myocardial infarction within the last 3 months prior to enrollment
- •Subject is known to be allergic to intolerant to an ingredient found in the study product
- •Subject has an aversion to the flavor of product being tested
- •Subject has an obstruction of the GI tract precluding ingestion or absorption of the study product, inflammatory bowel disease, gastric esophageal reflux disease, short bowel syndrome, or other major gastro-intestinal disease-causing symptoms including but not limited to uncontrollable severe diarrhea, nausea, or vomiting
- •Subject is taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect gastrointestinal motility.
- •Participation in another study that has not yet been approved as a concomitant study by the Sponsor.
- •Subject has a clinical condition that is contraindicated with this product.
- •Subject is pregnant.
研究组 & 干预措施
High Protein, Energy Dense Nutritional Supplement
2 servings per day
干预措施: High Protein, Energy Dense Nutritional Supplement (Other)
结局指标
主要结局
Gastro-Intestinal Tolerance
时间窗: Day 1 to Day 7
Subject completed Bristol Stool Type questionnaire; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools.
Nutritional Supplement Intake
时间窗: Day 1 to Day 7
Subject completed daily intake questionnaire including amount of Bottle 1 and Bottle 2 consumed
Nutritional Supplement Palatability
时间窗: Day 7
Subject completed 6, Likert Scale questions; 4 scaled in the negative direction; 2 scaled from Far Too to Not at all Enough for additional flavors
Nutritional Supplement Palatability
时间窗: Day 1 to Day 7
Subject completed 6, Likert Scale questions; 4 scaled in the negative direction; 2 scaled from Far Too to Not at all Enough
次要结局
未报告次要终点