High Energy, High Protein Tube Feed Study
Research type
Research Study
Full title
Evaluating the tolerance, compliance and acceptability of a nutritionally complete, high energy, high protein, enteral feed in adults – a pilot study
IRAS ID
222172
Contact name
Rebecca Stratton
Contact email
Sponsor organisation
Nutricia Ltd
Duration of Study in the UK
2 years, 8 months, 29 days
Research summary
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. Enteral feeding is intended to support those patients who are unable to eat sufficient quantities of food or oral supplements to meet their nutritional requirements or for whom oral intake is contraindicated, e.g. unsafe swallow.
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. Conditions such as cancer or acquired brain injuries can increase protein and energy requirements. For many of these patients, receiving large volumes of enteral feeds to meet these high requirements may be poorly tolerated. Additionally recent evidence has demonstrated that all adults over 65, both with and without chronic disease, require a higher protein intake then previously recommended to maintain muscle mass and function.
A high energy, high protein feed has therefore been developed, which provides 1.5kcal/ml and 7.5g protein/100ml. The aim of this study is to investigate the nutritional intakes, tolerance, compliance and acceptability of this feed in adult patients who require nutritional support via tube feeding.50 eligible patients will receive the high energy, high protein feed, in a quantity advised by their Dietitian and dependent on requirements, for 4 weeks. The primary outcome is nutritional intake. 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. Data will be recorded using questionnaires. Provision of blood samples will be optional and on a voluntary basis. All other measures are non-invasive.
Nutricia will fund the research. The feed is a Food for Special Medical Purposes and MHRA exempt
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0075
Date of REC Opinion
24 Feb 2017
REC opinion
Further Information Favourable Opinion