Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: An Evaluation of the Tolerance, Compliance and Acceptability of a Ready to Use, Liquid, High Energy, High Protein, Peptide-based Feed for Adults in Need of Nutrition Support - a Pilot Study
Brief Summary:
Oral nutritional supplements and enteral tube feeds are commonly used to meet the nutritional requirements of patients with disease-related malnutrition, or who require medical nutrition support for other reasons. Some patients may not tolerate standard formulations containing whole proteins (typically due to maldigestion/malabsorption) leading to gastrointestinal symptoms (i.e. vomiting and diarrhoea). Without appropriate management, this may lead to reduced nutritional intake, increased nutritional losses and risk of malnutrition in patients who may already have elevated nutritional requirements due to their clinical conditions.
Poor tolerance to standard feed formulations can be managed with extensively hydrolysed (peptide-based) enteral feeds, where the protein source is provided in smaller proteins. Patients with elevated nutritional requirements, poor tolerance, maldigestion and/or malabsorption often require a higher energy, higher protein feed to meet their nutritional requirements in a smaller volume of feed.
The study feed is a high energy (1.5kcal/ml), high protein (7.5g protein/100ml) peptide-based feed, available as a 500ml enteral tube feed, and a 200ml Vanilla-flavour oral nutritional supplement. The study will investigate the gastrointestinal tolerance, compliance and acceptability of the high energy, high protein peptide-based feed in 60 adult patients requiring a peptide-based feed, in several NHS sites across England. Patients will be asked to take the study feed for 28 days. Data will be recorded using questionnaires with no invasive measures.
The primary outcome is gastrointestinal tolerance with secondary outcomes of compliance, acceptability, nutrient intake and anthropometry.