Prospective Tolerance and Compliance Study With a High Caloric, High Protein Oral Nutritional Supplement in Nursing Home Residents - ad Libitum Intake
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 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
研究组 & 干预措施
Single-arm study
High caloric, high protein ONS, single dose of 400 kcal/day for 7 consecutive days, oral administration
干预措施: High caloric, high protein ONS (Dietary Supplement)
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
Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)
时间窗: At screening examination (study days -3 to -1)
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
- Compliance assessed by percentage of subjects who reached ≥ 75% of prescribed dose of ONS(At study days 1-7)
- Use of ONS assessed by servings(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)
- Use of ONS assessed by consumption time(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)
- Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in %)(At study days 1-7)