Acceptability of a Ready to Use, Low Calorie, Low Volume, High Protein Liquid for Patients With Increased Protein Needs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in Acceptability
研究概览
简要总结
The aim of this prospective, single-arm intervention study is to evaluate the acceptability (compliance, gastrointestinal tolerance, and palatability) to a low calorie, low volume, ready to use, high protein liquid in patients with elevated protein needs.
详细描述
Increased protein needs are frequently observed in disease and can be difficult for patients to achieve where oral food intake is compromised.Where a standard ONS or enteral tube feed cannot meet the needs of patients, a modular feed can be added to the regimen, a low calorie, low volume, ready to use, high protein liquid may help meet protein needs while preventing caloric overfeeding.
40 patients will be recruited in an attempt to evaluate the acceptability (compliance, gastrointestinal tolerance, and palatability) to a low calorie, low volume, ready to use, high protein liquid in patients with elevated protein needs. After a 1-day baseline period to establish patients' acceptability, gastrointestinal tolerance, compliance and dietary intake with their currently prescribed nutritional regimen, each patient will receive the high protein liquid feed daily for 28 days.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older.
- •Patients under the care of a Dietitian requiring oral or enteral nutritional support, with -increased protein needs.
- •To receive a minimum of 1 x 40ml HPLM daily (orally or via enteral tube) while on the study.
- •Informed consent obtained from the patient
排除标准
- •Total parenteral nutrition (100% of requirements).
- •Patients with major hepatic dysfunction (i.e. decompensated liver disease).
- •Patients with major renal dysfunction (i.e. requiring filtration or Stage 4/5 chronic kidney disease (CKD)).
- •Participation in other studies within 1 month prior to entry of this study.
- •Patient with severe lactose intolerance.
- •Pregnant or lactating.
- •Patient lacks capacity to consent for themselves.
研究组 & 干预措施
High protein liquid
A ready to use, low calorie, low volume, ready to use, high protein liquid modular (HPLM) feed for adults.
干预措施: High protein liquid (Other)
结局指标
主要结局
Change in Acceptability
时间窗: 2 days (days 1 and 29)
Acceptability of the patients existing feeding regimen (including any protein module use) will be assessed on day 1, baseline period. Acceptability with the study product will be assessed at the end of the intervention period using a standardised questionnaire completed by the patient.
次要结局
- Compliance(29 days)
- Change in Gastrointestinal tolerance(4 days (day 1, 8, 15 and 29))
- Change in Nutrient Intake (24-hour dietary recall)(2 days (day 1 and 29))
- Change in Physical Function (30-s Chair Stand Test)(2 days (day 1 and 29))
- Change in MUST Screening(2 days (day 1 and 29))
- Change in Height(2 days (day 1 and 29))
- Change in Weight(2 days (day 1 and 29))
- Dietetic Goal(1 day (day 29))
- Adverse events(29 days (assessed daily))
- Patient history(1 day (day 1))