Acceptability and Tolerance Study of a Plant-based Tube Feed

Nutrition Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06209593
• Other study ID #: PB 001
• Status: Recruiting
• Start date: January 5, 2024
• Est. completion date: June 3, 2024

Study information

• Verified date: May 2024
• Source: Société des Produits Nestlé (SPN)
• Contact: James Evans
• Phone: 0203 447 9289
• Email: j.evans28[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 3, 2024
• Est. primary completion date: June 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Nutrition Disorders

Intervention

Dietary Supplement:
• Compleat plant protein tube feed
Patients on a tube feed will act as their own control and switch to new tube feed.

Locations

Country	Name	City	State
United Kingdom	Nu	London

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline assessment and daily recording during intervention up to day 7 measuring Gastrointestinal tolerance	Diarrhoea, constipation, reflux, vomiting, wind, boating	7 days