Tolerance and Acceptability Evaluation of AYMES Protein Shot
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Acceptability and Palatability of Oral Nutrition 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, taken either orally or via a feeding tube
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, either taken orally or with a feeding tube. Outcomes of GI effects, compliance, product preference, convenience etc. 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
- •Adult patients (≥18 years) who are able to communicate clearly.
- •Diagnosis of renal disease or confirmed requirement for protein supplementation by a suitably qualified health care professional (e.g. dietitian)
- •Participants with or at risk of malnutrition as determined by the SGA nutritional screening tool, MUST and/or by professional clinical judgement.
- •Participants expected to require an ONS for at least 28 days from baseline, to take flavour variants orally and neutral via feeding tube.
- •Informed consent obtained.
排除标准
- •Participation in any other studies involving investigational or marketed products concomitantly or within seven days prior to entry into the study
- •Patients with medical or dietary contraindication to any ingredients (see appendix 2 of protocol for full list.)
- •No feeding tube for any patient taking the neutral variant.
- •Patients with significant hepatic impairment.
- •Patients with dysphagia requiring IDDSI level 1 (or higher) fluids.
- •Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
- •Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
- •Any participant unable to give consent i.e., those with dementia.
- •Participants under 18 years of age.
- •Individuals who do not have sufficient proficiency with English language
- •Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.
研究组 & 干预措施
Shot style protein supplement
Patients with or at risk of DRM, who have been clinical identified as requiring additional protein will be prescribed the study product for a period of 7-28days. Study product can be taken either orally or via a feeding tube.
干预措施: Shot Style protein supplement (Dietary Supplement)
结局指标
主要结局
Acceptability and Palatability of Oral Nutrition Supplement
时间窗: 28 days
To assess the acceptability of the shot-style protein supplement in patients requiring oral nutritional supplementation. On day 7 and 28 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. A 5 point hedonic scale will be used.
Gastro-Intestinal (GI) Tolerance
时间窗: 7 days
To assess the GI tolerance of the shot-style protein supplement in patients with or at risk of disease related malnutrition, requiring additional protein, either fed orally or with a feeding tube. Monitoring includes recording the number of any GI complaints and consistency of bowel movements via a diary for the first 7 days
Compliance
时间窗: 28 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
- Safety of consumption of Study Product(7 days)