Acceptability and Tolerance Study of a Plant-based Tube Feed

Nestlé

Status: Completed

Conditions: Nutrition Disorders

Treatments: Dietary Supplement: Compleat plant protein tube feed

Study type: Observational

Funder types: Industry

Identifiers

NCT06209593

PB 001

Details and patient eligibility

About

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.

Full 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

Enrollment: 15 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

Patients well established on tube feeds will act as their own control

Description:

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.

Treatment:

Dietary Supplement: Compleat plant protein tube feed