High Energy High Protein Peptide Feed Study
Malnutrition, Malabsorption
About this trial
This is an interventional supportive care trial for Malnutrition focused on measuring Enteral feeding, Oral nutritional supplements, Peptide-based feed, Hydrolysed feed, Semi-elemental feed
Eligibility Criteria
Inclusion Criteria:
- Male or female
- Age 18 years and over
- Requiring a peptide-based feed to meet nutritional requirements
- Expected to receive at least 300kcal if taken orally or at least 500kcal if taken by tube
Exclusion Criteria:
- Patients receiving total 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 in intensive care
- Patients with galactosaemia or severe lactose intolerance
- Participation in other clinical studies within 2 weeks prior to entry of this study
- Investigator concern around willingness/ability of patient to comply with protocol requirements
Sites / Locations
- Cumbria Partnership NHS Foundation TrustRecruiting
- Derby Teaching Hospitals NHS Foundation TrustRecruiting
- Gloucestershire Hospitals NHS Foundation TrustRecruiting
- Royal Surrey County Hospital NHS Foundation TrustRecruiting
- University Hospitals Birmingham NHS Foundation TrustRecruiting
- Frimley Health NHS Foundation TrustRecruiting
- Guys and St Thomas NHS Foundation TrustRecruiting
- Lewisham and Greenwich NHS Foundation TrustRecruiting
- Sheffield Teaching Hospitals NHS Foundation TrustRecruiting
- Great Western Hospitals NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Experimental
High energy high protein peptide feed
This is a one-arm study. Each patient recruited onto the study will receive the high energy, high protein peptide-based feed for a period of up to 4 weeks (28 days). The feed will be available as an enteral tube feed in a 500ml bottle, and as a Vanilla flavoured oral nutritional supplement in a 200ml plastic bottle. The appropriate feed presentation (tube feed or oral nutritional supplement) 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) .