Evaluation of a Nutritionally Complete, Plant-based, High Energy, High Protein, Enteral Tube Feed in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in gastrointestinal tolerance
研究概览
简要总结
The primary aim of this study is to investigate the effects of a plant-based, high energy, high protein tube feed with and without inclusion of fibre on gastrointestinal tolerance in adult patients who require nutritional support via enteral tube feeding over a 28-day period, followed by a 12-month follow-up. Secondary aims are to determine the effects on compliance, acceptability, anthropometry, nutrient intake, and physical function. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period and a 1-year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •≥16 years of age
- •Using or requiring an enteral tube feed in the community as part of nutritional management plan
- •Expected to receive at least 1000kcal/day (one bottle) from one of the study products
排除标准
- •Receiving parenteral nutrition
- •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))
- •Patients receiving inpatient care
- •Known pregnancy or lactation
- •Participation in other clinical intervention studies within 1 month of this study
- •Allergy to any study product ingredients
- •Investigator concern regarding ability or willingness of patient to comply with the study requirements.
研究组 & 干预措施
Intervention
Patients will receive a minimum of 1 bottle per day of either (or both of) 2kcal HP PlantBased and/or 2kcal HP PlantBased MultiFibre Tube Feeds for a minimum of 7 days and a maximum of 28 days. During the 12-month follow-up, patients will have access to the same trial prescription as per the 28-day intervention period.
干预措施: 2kcal HP PlantBased (Dietary Supplement)
结局指标
主要结局
Change in gastrointestinal tolerance
时间窗: Change from baseline (Day 1) to end of follow-up (12 months)
A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity
次要结局
- Acceptability(Baseline to end of intervention (7-28 days) and end of follow-up (12 months))
- Anthropometry(Baseline to end of intervention (7-28 days) and end of follow-up (12 months))
- Dietetic goal(Baseline to end of intervention (7-28 days) and end of follow-up (12 months))
- Safety (Adverse events)(Baseline to end of intervention (7-28 days) and end of follow-up (12 months))
- Handgrip strength(6-months to 12-months follow-up)
- Compliance(Baseline to end of intervention (7-28 days) and end of follow-up (12 months))
- Calf circumference(6-months to 12-months follow-up)
- 30-s Chair Stand Test(6-months to 12-months follow-up)
- Dietary intake(Baseline to end of intervention (7-28 days) and end of follow-up (12 months))