Evaluating the Tolerance, Compliance and Acceptability of a Nutritionally Complete, High Energy, High Protein, Enteral Feed in Adults - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 14
- 主要终点
- Change in nutrient intakes (energy, protein, fluid and micronutrients)
研究概览
简要总结
Enteral tube feeds are commonly used to meet the entire or partial nutritional requirements of patients with disease-related malnutrition and other conditions who need nutrition support. A large proportion of tube fed patients have increased protein and/or energy requirements due to a higher body mass or increased metabolic stress as a result of disease, surgery or trauma. A high energy, high protein feed has been developed to help meet the needs of such patients. The aim of this study is to investigate the tolerance, compliance and acceptability of this high energy high protein tube feed in adult patients who require nutritional support via tube feeding. 50 eligible patients requiring tube feeding will receive the high energy, high protein feed, according to nutritional requirements for 4 weeks. The primary outcome is nutritional intake, and secondary outcomes include gastrointestinal (GI) tolerance, compliance, acceptability and functional measures. Additional exploratory outcomes of quality of life and micronutrient levels will also be investigated.
详细描述
Introduction
The present study will investigate the effect of a high energy, high protein tube feed in patients requiring enteral feeding in the community. The primary objective is to evaluate the effect of daily intake of the high energy, high protein tube feed, in addition to appropriate nutritional management, on total nutrient intakes for 4 weeks. The secondary objectives are to evaluate the effect of daily intake of the feed on gastrointestinal tolerance, compliance, acceptability and functional measures. Additional exploratory measures will be quality of life and micronutrient levels. Enteral tube feeding patients will be recruited by the dietitians responsible for their care, from a variety of dietetic services across the United Kingdom. Potential participants that require a high energy, high protein tube feed will already be known to the Investigating Dietitian or dietetic team at the investigating sites or will be referred to the dietetic service during the duration of the study.
Intervention
Following a 3 day baseline period, each patient will receive the high energy, high protein tube feed for a period of 4 weeks (28 days). The appropriate feed and prescription will be determined on an individual basis by the Dietitian responsible for the patient's nutritional management, based on the patient's clinical requirement and preference and the Dietitian's clinical judgement.
The study feed is classed as a 'Dietary Food for Special Medical Purposes' (EC Directive 1999/21/EC, 1999).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
High Energy High Protein Tube Feed
As study is a single arm design, all patients will be in the intervention group. The will act as their own control by means of a 3 day baseline period. All patients in the study will receive the same intervention, the high energy high protein tube feed, in quantities specified by their dietitian based on their nutritional requirements.
干预措施: High Energy High Protein Tube Feed (Dietary Supplement)
结局指标
主要结局
Change in nutrient intakes (energy, protein, fluid and micronutrients)
时间窗: Measurements will be taken at Baseline (DAY 1) and End of Study (DAY 31).
Nutrient intakes, including the intake of all nutrition provided (including the study feed, other enteral tube feeding, foods, drinks and oral nutritional supplements) will be recorded using 24hr diet recalls. Nutritics® (https://www.nutritics.com/p/references), a dietary analysis program, will be used to calculate energy, protein, micronutrient and fluid intakes.
次要结局
- Gastro-intestinal tolerance(Gastro-intestinal tolerance will be recorded at baseline (DAY 1, 2 and 3) and on days 4, 5, and 6 of the study (the first 3 days the patient is taking the study feed) and once at the end of each week the patient is taking the feed.)
- Compliance with feed prescription measured via daily feed intake recoding(Every day throughout study completion, 31 days in total.)
- EQ-5D Quality of life(Measurements will be taken at Baseline (DAY 1) and End of Study (DAY 31).)
- Acceptability(End of study (DAY 31))
- Muscle Function (hand grip strength)(Measurements will be taken at Baseline (DAY 1) and End of Study (DAY 31).)
- Micronutrient status(Measurements will be taken at Baseline (DAY 1) and End of Study (DAY 31).)