Acceptability and Tolerance Study of a Plant-based Tube Feed

NCT06209593 | Completed DMC

• 1 other identifier: PB 001
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition Disorders

Outcome Measures

Primary Outcomes (1)

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

  Diarrhoea, constipation, reflux, vomiting, wind, boating

  7 days

Study Arms (1)

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.

Dietary Supplement: Compleat plant protein tube feed

Interventions

Compleat plant protein tube feed DIETARY_SUPPLEMENT

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

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

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients established on a tube feed

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Nu

London, United Kingdom

Location

MeSH Terms

Conditions

Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• James Evans

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 17, 2024
• Study Start: January 5, 2024
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)