Tolerance and Acceptability Evaluation of AYMES SWIFT
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Acceptability and palatability of an oral nutriitonal supplement.
研究概览
简要总结
To evaluate the tolerance (gastrointestinal) and acceptability of a new Oral Nutrition Supplement in patients with or at risk of disease related malnutrition.
详细描述
To evaluate tolerance and acceptability of a new Oral Nutrition Supplement in patients with or at risk of malnutrition, who require supplementary nutrition support. Outcomes of GI effects, compliance and palatability will be recorded.
To obtain data to support an ACBS submission (to allow for prescription in the community at NHS expense).
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
- •Male or female
- •≥ 18 years of age
- •Identified as being malnourished/at risk of malnutrition-by-malnutrition screening tools [i.e., MUST score ≥1, and/or using or requiring ONS at least once daily as part of nutritional management plan]
- •Expected to receive at least one bottle of ONS per day
- •Written or electronic informed consent from patient, or verbally given consent countersigned by a witness for those physically unable to sign
排除标准
- •Participants receiving parenteral nutrition or ≥70% total energy requirements from enteral tube feeding
- •Participants with major hepatic dysfunction (i.e., decompensated liver disease)
- •Participants with major renal dysfunction [i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD)]
- •Participants with active/chronic gastrointestinal disease or impaired gastrointestinal function
- •Participants with significant dysphagia/high aspiration risk
- •Participation in other clinical intervention studies within 1 month of this study
- •Participants lacking mental capacity to consent
- •Allergy to any study product ingredients (appendix 2)
- •Investigator concern regarding ability or willingness of patient to comply with the study requirements.
研究组 & 干预措施
AYMES SWIFT
Patients with or at risk of disease related malnutrition (DRM), who have been clinically identified as requiring nutritional supplementation will be prescribed the study product for a period of 7 days.
干预措施: AYMES SWIFT oral nutritional supplement (Dietary Supplement)
AYMES SWIFT
Patients with or at risk of disease related malnutrition (DRM), who have been clinically identified as requiring nutritional supplementation will be prescribed the study product for a period of 7 days.
干预措施: AYMES SWIFT FIBRE (Dietary Supplement)
AYMES SWIFT
Patients with or at risk of disease related malnutrition (DRM), who have been clinically identified as requiring nutritional supplementation will be prescribed the study product for a period of 7 days.
干预措施: AYMES SWIFT PLANT (Dietary Supplement)
结局指标
主要结局
Acceptability and palatability of an oral nutriitonal supplement.
时间窗: 7 days
To assess the acceptability of the oral nutritional supplement in patients requiring oral nutritional supplementation. On day 7 of the intervention period an acceptability and preference questionnaire will be completed by the patient in order to seek their opinion on the taste, smell, texture and overall liking of the new oral nutrition supplement. Questions will be rated on a 7 point Likert scale (Strongly Agree, Somewhat agree, Neutral, Somewhat Disagree, Disagree, Disagree Strongly) and will relate to taste, smell, texure and overall liking.
Gastro-intestinal Tolerance
时间窗: 7 days
To assess the GI tolerance of the oral nutritional supplement in patients with or at risk of disease related malnutrition. Monitoring includes recording the number of any GI complaints and consistency of bowel movements via a diary for the first 7 days. A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea) will be recorded on day 1 (based on the 2 preceding days) and for the first 7 days during the intervention. Information about bowel movements will also be collected using the Bristol Stool Chart© at the same time points.
Compliance
时间窗: 7 days
To assess the compliance of patients taking the Study product as prescribed. This is measured by daily completion of a compliance diary, comparing consumed amount versus prescribed amount.
次要结局
未报告次要终点