Acceptability and Tolerance Study of Compleat® 1.5 HP
Research type
Research Study
Full title
Acceptability (including gastrointestinal tolerance and compliance) of a high energy adult enteral formula with food-derived ingredients.
IRAS ID
324749
Contact name
Martha Van Der Linde
Contact email
Sponsor organisation
Nestle Health Science
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 21 days
Research summary
This is acceptability study to evaluate the gastrointestinal tolerance and compliance over a 14-day period with Compleat® 1.5 HP. Compleat is a food for special medical purposes. The feed includes food derived ingredients. It is used for the dietary management of short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, disease related malnutrition. Participants will be over 15 years old and will be asked to be on the study formula for 14 days. 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. For the ACBS we need data for 7 days, but we have extended the study to 14 days as in dietetic practice for some patients a switch to new tube feed formula may happen over 1-3 days e.g. 25% of nutritional requirements at day 1, then 50% nutritional requirements at day 2, with full nutritional requirements at day 3.There is currently very little research in the use of blended diets in the adult population. However, this trend is also growing in popularity. The Patients must be well established and stable on a standard 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®. They or their parent/caregiver complete a daily gastrointestinal tolerance diary for 14 days and formula intake for 14 days on usage, tolerance, acceptability, and compliance.
A brief questionnaire will be completed at the end of the study on Day 14 by the healthcare professional to assess any perceived changes to tolerance, compliance, and patient satisfaction.
Once participants have completed the 14-day study product supply will stop and participants will return to their existing feeding regimen.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
23/YH/0036
Date of REC Opinion
20 Mar 2023
REC opinion
Further Information Favourable Opinion