NCT04945083已完成不适用
Gastrointestinal Tolerance and Acceptability of a High Protein, High Calorie Pudding in Adult Patients With/or at Risk for Malnutrition
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
- 3
- 主要终点
- Gastro-Intestinal Tolerance
研究概览
简要总结
This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study to evaluate the tolerance of a nutritional pudding.
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 an ICF approved by an IEC, and provided applicable privacy authorization prior to any participation
- •Subject is considered by a dietitian or clinician as malnourished or at risk for malnutrition based on current use of an oral nutritional supplement (ONS), recently identified as malnourished or at risk of malnutrition based on validated malnutrition screening tool or has had weight loss within last two months as a result of a hospitalization or chronic illness
- •Subject currently has normal GI function
- •Subject requires ONS and is willing to comply with the study protocol
排除标准
- •Subject has severe dementia or delirium, 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 had a history of diabetes as evidenced by taking antihyperglycemic medications or by self-reported dietary modification
- •Subject is currently taking or has taken antibiotics within 1 week prior to enrollment
- •Subject has undergone major GI surgery less than 3 months prior to enrollment in the study
- •Subject has current active malignant disease or was treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma, prior to enrollment
- •Subject has an immunodeficiency disorder
- •Subject has had a myocardial infarction within the last 3 months prior to enrollment
- •Subject is known to be allergic or intolerant to any ingredient found in the study product
- •Subject has an aversion to any of the flavours 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 gastrointestinal disease-causing symptoms including (but not limited to) uncontrollable severe diarrhea, nausea, or vomiting
- •Subject is currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect gastrointestinal motility
- •Participation in another study that has not been approved as a concomitant study
- •Subject has a clinical condition that is contraindicated with this product as determined by the clinician in accordance with standard of care
- •Subject is pregnant
研究组 & 干预措施
Experimental Nutritional Pudding
Experimental
2 servings per day
干预措施: Experimental Nutritional Pudding (Other)
结局指标
主要结局
Gastro-Intestinal Tolerance
时间窗: Study Day 1 to Study Day 8
Subject completed Bristol Stool Type questionnaire; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools
次要结局
- Nutritional Supplement Palatability(Study Day 1 to Study Day 8)
- Nutritional Supplement Compliance(Study Day 1 to Study Day 28)
研究者
研究点 (3)
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