Exploratory Randomised, Controlled Trial To Evaluate The Impact Of Four Nutritionally Complete, Plant-Protein Dominant, Enteral Tube Feeds On Long Term Outcomes In Community-Based Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in gastrointestinal tolerance
研究概览
简要总结
This study aims to determine whether a reformulated plant-protein dominant protein blend in four existing enteral tube feeds is as effective as animal-protein dominant formulations in patients who are tube fed at home. This is an exploratory randomised, controlled, trial with a 3-day baseline period. Adult home tube feeding patients will be randomised to receive either a plant-protein dominant formulation or a control product (an animal-protein dominant formulation) for a 3-month intervention period followed by a 6-month and 12-month follow-up. The outcomes include gastrointestinal tolerance, compliance, acceptability, anthropometry, nutrient intake, and physical function
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 500ml (≥500kcal) per day 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
Animal-Protein Dominant Control
During the 3-day baseline period, each patient will receive their usual enteral tube feeding prescription as determined by their dietitian. Following the 3-day baseline period, all patients will enter the 90-day intervention period, where they will receive one (or a combination) of the animal-protein dominant feed (control) daily.
干预措施: Animal-protein dominant enteral feed (Dietary Supplement)
Plant-Protein Dominant Intervention
During the 3-day baseline period, each patient will receive their usual enteral tube feeding prescription as determined by their dietitian. Following the 3-day baseline period, all patients will enter the 90-day intervention period, where they will receive one (or a combination) of the plant-protein dominant feeds.
干预措施: Plant-protein dominant enteral feed (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 intervention (Day 93) and end of follow up (12 months)
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).
Acceptability
时间窗: Baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months)
Acceptability (e.g., liking, ease of use, preference) will be assessed by a questionnaire. Questions will be rated on a 7-point Likert scale (1 strongly disagree - 7 strongly agree)
Compliance
时间窗: Baseline to end of intervention (93 days) and end of follow-up (12 months)
Compliance with the study product prescription (%) will be assessed daily by recording how much of the study product was prescribed compared to the amount administered.
Nutritional intake
时间窗: Baseline to end of intervention (Day 93) and end of follow-up (12 months)
A 24-h dietary recall will be conducted to record all food, drink and nutritional feeds taken in the 24 hours prior for analysis of daily nutritional intake i.e., total energy intake (kcal/day) and macro- and micronutrients (g/day or mg/day).
Body weight
时间窗: Baseline to end of intervention (Day 93) and end of follow-up (12 months)
Body weight (kg) will be measured using standard methods to the nearest 0.1kg using a weighing scale without heavy clothing. Height and weight measures will be used to calculate body mass index (BMI) as kg/m\^2.
Height
时间窗: Baseline to end of intervention (Day 93) and end of follow-up (12 months)
Height will be measured at baseline only using standard measures to the nearest 0.1cm, without shoes or socks. Height and weight measures will be used to calculate body mass index (BMI) as kg/m\^2.
Calf circumference
时间窗: Baseline to end of intervention (Day 93) and end of follow-up (12 months)
Calf circumference will be measured using standard measures to the nearest 0.1cm
30-s Chair Stand Test
时间窗: Baseline to end of intervention (Day93) and end of follow-up (12 months)
Number of times patients can stand up and sit down from a chair within 30 seconds.
Handgrip strength
时间窗: Baseline to end of intervention (Day93) and end of follow-up (12 months)
A novel dynamometer will be used to assess muscle strength (kg) via a maximal grip strength test
Hand Grip Fatiguability
时间窗: Baseline to end of intervention (Day93) and end of follow-up (12 months)
Muscle fatigability (in seconds) will be measured using a fatigue resistance test on a novel hand grip dynamometer
Capacity to Perceived Vitality (CPV) ratio
时间窗: Baseline to end of intervention (Day93) and end of follow-up (12 months)
Vitality capacity, measured as Capacity to Perceived Vitality (CPV) ratio will be calculated using fatiguability, measured with a novel hand grip dynamometer combined, combined with the score from a validated questionnaire
Sarc-CalF tool
时间窗: Baseline to end of intervention (Day93) and end of follow-up (12 months)
Sarcopenia screening tool consisting of a 5 question questionnaire combined with calf circumference measurement. A score ≥ 11 points is suggestive of sarcopenia.
次要结局
未报告次要终点