Acceptability and Tolerance Study of a Plant-based Tube Feed
Recruiting
- Conditions
- Nutrition Disorders
- Interventions
- Dietary Supplement: Compleat plant protein tube feed
- Registration Number
- NCT06209593
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients well established on tube feeds will act as their own control Compleat plant protein tube feed Each participant will receive the new trial feed a nutritionally complete standard enteral tube feed for a period of 7 days. The new trial feed is a food for special medical purposes for use under medical supervision. The Health Care Professional/ dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube.
- Primary Outcome Measures
Name Time Method Baseline assessment and daily recording during intervention up to day 7 measuring Gastrointestinal tolerance 7 days Diarrhoea, constipation, reflux, vomiting, wind, boating
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nu
🇬🇧London, United Kingdom