Plant-protein dominant feed study
Research type
Research Study
Full title
Exploratory randomised, controlled trial to evaluate the impact of four nutritionally complete, plant-protein dominant, enteral tube feeds on long term outcomes in community-based adults
IRAS ID
354515
Contact name
Sophie Bell
Contact email
Sponsor organisation
Nutricia Ltd
Clinicaltrials.gov Identifier
67127, CPMS ID
Duration of Study in the UK
1 years, 11 months, 16 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 which 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. It is estimated that there are over 40,000 adults receiving home enteral tube feeding in their own homes or care homes in the UK.
In recent years, there has been a strong trend towards plant-based diets in the UK, with people increasingly choosing a plant-based diet, or an increased proportion of plant-based proteins for personal, health, environmental/sustainability, cultural or religious reasons. To meet these needs, four currently available enteral tube feeds have been reformulated to contain a plant-protein dominant protein blend, with 78% plant-derived protein. However, there remains a lack of research investigating the long-term use of enteral tube feeds containing a plant-protein dominant protein blend.
This study aims to determine whether a plant-protein dominant enteral tube feed is as effective as animal-protein dominant formulations in patients who are tube fed at home. This is an exploratory, randomised controlled trial with a 3-day baseline period. Adult home tube feeding patients will be randomised to receive either a plant-protein dominant formulation or a control product (an animal-protein dominant formulation) for a 3 month intervention period, with an optional further 9 month follow up period for those who wish to continue taking the feed (12 months total). The outcomes that will be explored include gastrointestinal tolerance, compliance, acceptability, effect on body weight and functional outcomes.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
25/LO/0263
Date of REC Opinion
15 May 2025
REC opinion
Further Information Favourable Opinion