Acceptability and Tolerance Study of 1.6 plant-based tube feed
Research type
Research Study
Full title
Acceptability (including gastrointestinal tolerance and compliance) of a plant based high energy adult enteral formula
IRAS ID
331506
Contact name
James Evans
Contact email
Sponsor organisation
Nestle Health Sciences
Duration of Study in the UK
0 years, 5 months, 28 days
Research summary
This is an acceptability study to evaluate the gastrointestinal tolerance and compliance of a non-dairy high energy, adult enteral feed, Compleat® plant protein 1.6, over a 7-day period for 15 participants.
The enteral formula is for the dietary management of patients with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, and disease related malnutrition.
With enteral feeding becoming a common practice for patients who are critically unwell or require tube feeding to provide good nutrition and hydration, the selection for vegans is very limited. A plant based vegan friendly tube feed is a need amongst our health care professionals (HCPs)
The intended population is adults who would prefer a vegan option. This feed contains pea protein a different type of plant based. Some patients may prefer to adopt a pea protein-based tube feed rather than a soy-based tube feed that is currently available.
The study is of relevance to patients and healthcare professionals as it will provide data to be submitted from a minimum of 15 participants to apply to the Advisory Committee on Borderline Substances (ACBS) in the UK. ACBS, we need data for 7 days
The Patients must be well established and stable on a current polymeric enteral tube feed.
Baseline questionnaire will be completed by a healthcare professional to capture current trends in gastrointestinal symptoms and medical history. 15 participants replace their usual feed with Compleat® plant protein 1.6. They or their caregiver complete a daily gastrointestinal tolerance diary for 7 days and formula intake for 7 days on usage, tolerance, acceptability, and compliance. A brief questionnaire will be completed at the end of the study on Day 7 by the healthcare professional to assess any changes to tolerance, compliance, and patient satisfaction. Once participants have completed the 7-day study product supply will stop and participants will return to their existing feeding regimen.REC name
South Central - Berkshire Research Ethics Committee
REC reference
23/SC/0288
Date of REC Opinion
14 Sep 2023
REC opinion
Further Information Favourable Opinion