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Completed

NCT Number: NCT06209593

Acceptability and Tolerance Study of a Plant-based Tube Feed

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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Key information

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nu

London, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compleat plant protein tube feed

Dietary Supplement

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

Primary outcomes

  1. Baseline assessment and daily recording during intervention up to day 7 measuring Gastrointestinal tolerance

    Time frame: 7 days

    Diarrhoea, constipation, reflux, vomiting, wind, boating

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Acceptability (including Gastrointestinal Tolerance and Compliance) of a Plant Based High Energy Adult Enteral Formula

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 17, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.