Acceptability and Tolerance Study of a Plant-based Tube Feed

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-05

Study Completion Date

2024-09-03

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Nutrition Disorders

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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

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.

Compleat plant protein tube feed

Intervention Type DIETARY_SUPPLEMENT

Patients on a tube feed will act as their own control and switch to new tube feed.

Interventions

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Compleat plant protein tube feed

Patients on a tube feed will act as their own control and switch to new tube feed.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No