NCT02938234已完成不适用
Prospective Tolerance and Compliance Study With a High Caloric, High Protein Oral Nutritional Supplement in Nursing Home Residents - ad Libitum Intake
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)
研究概览
简要总结
The aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and use of a high caloric, high protein oral nutritional supplement (ONS) in elderly people
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sex: male/female
- •Age: 65 years or older
- •Body-mass index (BMI): ≥ 16.0 kg/m² and ≤ 30.0 kg/m²
- •Subjects with an indication for ONS of approx. 400 kcal per day for at least 7 days
- •Written informed consent
排除标准
- •Existing gastrointestinal diseases or pathological findings, which do not allow enteral nutrition
- •Subjects with galactosaemia or similar metabolic disorders
- •Subjects with severely impaired gastrointestinal function or complete failure
- •Subjects with insulin-requiring diabetes
- •Subjects with acute diarrhoea (defined as ≥ 3 loose or watery stools per day)
- •Subjects reporting frequent occurrence of migraine attacks
- •Subjects with acute or (current) chronic diseases, which might lead to impaired gustatory sense (e.g. sinusitis, anosmia)
- •Existing mouth abnormalities, which cause impaired gustatory sense
- •Subjects who report impaired gustatory sense (e.g. due to intake of concomitant medication)
- •Subjects passing through chemotherapy (last cycle < 2 months ago)
- •Known allergic reactions or intolerance to any ingredient used or to constituents of the ONS
- •Subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical study by the investigator
- •Consumption of any additional ONS, enteral nutrition via tube or parenteral nutrition
- •Subjects with need of a special diet contradicting the intake of the ONS
- •History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- •Subjects with dysphagia or with high aspiration risk
- •Enrolment in another clinical study
- •Administration of any investigational medicinal product during the last month prior to individual enrolment of the subject
- •Subjects who are not able to self-report GI-problems and compliance
- •Subjects who report a general dislike of the ONS flavour
- •Subjects for whom a hospitalisation for rehabilitation or surgery during the study is planned
- •Subjects suspected or known not to follow instructions
- •Subjects unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical study
结局指标
主要结局
Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)
时间窗: At end of study (study day 8)
The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain
Gastro-intestinal (GI) tolerance assessed by subject (presence of GI symptoms assessed by subject's questionnaire)
时间窗: At study days 1-8
The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain
次要结局
- Use of ONS assessed by consumption time(At study days 1-7)
- Compliance assessed by percentage of subjects who reached ≥ 75% of prescribed dose of ONS(At study days 1-7)
- Palatability of ONS (assessed by subject's questionnaire by using a 5-point hedonic-scale)(At study day 1 and at study day 7)
- Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in mL)(At study days 1-7)
- Use of ONS assessed by servings(At study days 1-7)
- Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in %)(At study days 1-7)
- Use of ONS assessed by presentation(At study days 1-7)
- Reasons for non-compliance and non-use of ONS on a specific day or for early termination (provided by subject by open question)(At study days 1-7)
研究者
研究点 (2)
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