Nutrition Disorders
Conditions
Brief summary
This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 7-day period with a plant based tube feed.
Detailed description
Enterally fed adults who are assessed by the Health Care Professional/dietitian as requiring an adult plant- based high-energy, enteral formula will be recruited. Data from 15 participants are required in order to submit an application to the UK Advisory Committee on Borderline Substances (ACBS) for product registration
Interventions
DIETARY_SUPPLEMENTCompleat plant protein tube feed
Patients on a tube feed will act as their own control and switch to new tube feed.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients 16 years and over and adults requiring a plant- based enteral tube feed (taking 50% or more of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition * Patients well-established and stable on current polymeric enteral tube feed. * Willingly given, written, informed consent from patient
Exclusion criteria
* Inability to comply with the study protocol, in the opinion of the investigator * Under 16 years of age * Patients on total parenteral nutrition * Known food allergies to any ingredients including patients who have an allergy to milk protein e.g IgE and non- mediated as product contains traces of milk and allergy to peanuts due to the pea protein * Patients with significant renal or hepatic impairment * Participation in another interventional study within 2 weeks of this study. * Patients with known or suspected ileus or mechanical bowel obstruction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline assessment and daily recording during intervention up to day 7 measuring Gastrointestinal tolerance | 7 days | Diarrhoea, constipation, reflux, vomiting, wind, boating |
Countries
United Kingdom
Outcome results
None listed