2kcal Tube Feed Study
Research type
Research Study
Full title
Evaluation of a nutritionally complete, plant-based, high energy, high protein, enteral tube feed in adults
IRAS ID
309578
Contact name
Corbin Griffen
Contact email
Sponsor organisation
Nutricia UK Ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Central portfolio management system, 51114
Duration of Study in the UK
3 years, 4 months, 26 days
Research summary
Enteral tube feeds are commonly used to meet the entire or partial nutritional requirements of patients with disease-related malnutrition (DRM) and other conditions who need nutrition support. Enteral tube feeding is intended to support those patients with a functional or partially functional gastrointestinal tract who are unable to eat sufficient quantities of foods or oral nutritional supplements to meet their nutritional requirements, or for whom oral intake is contraindicated, e.g., unsafe to 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 chronic obstructive pulmonary disease (COPD), many cancers, heart failure, liver disease, and acquired brain injuries can all increase protein and energy requirements. To meet these higher requirements, many of these patients need to receive a large volume of enteral feed, which may be poorly tolerated and/or not feasible due to requiring long feeding periods. For such patients, enteral feeds containing more protein and energy in a smaller volume may improve tolerance and enable patients to better meet their nutritional requirements and reduce the time spent tube feeding.
In particular, adults aged ≥65 years, both with and without chronic disease, require a higher protein intake to maintain skeletal muscle mass and function. Whilst animal-derived protein sources are often recommended to maintain muscle function, in recent years, there has been a strong trend towards plant-based diets in the UK, with people increasingly choosing a plant-based diet for personal, health, environmental/sustainability, cultural or religious reasons. Although there has been a proliferation of plant-based food products available to consumers, patients and healthcare professionals have extremely limited choice if they require plant-based nutrition support. In order to meet these nutritional needs, a nutritionally complete, plant-based, high energy (2kcal/mL), high protein (10g protein/100mL) tube feed with and without inclusion of fibre (1.5g/100mL) has been developed. However, research is needed to investigate tolerance (primary outcome), compliance, acceptability and safety of these feeds.
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. Secondary aims are to determine the effects on compliance, acceptability, anthropometry, nutrient intake, and safety. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period. The study is being conducted for Advisory Committee on Borderline Substances (ACBS) and General Medical Services Scheme (GMS) reimbursement in the UK and Ireland, respectively, and is designed to meet their requirements for acceptability studies.
REC name
Wales REC 4
REC reference
22/WA/0038
Date of REC Opinion
14 Feb 2022
REC opinion
Further Information Favourable Opinion