Status:

COMPLETED

Acceptability and Tolerance Study of a Plant-based Tube Feed

Lead Sponsor:

Société des Produits Nestlé (SPN)

Conditions:

Nutrition Disorders

Eligibility:

All Genders

16-80 years

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.

Detailed 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 require...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 5 2024

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 3 2024

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT06209593

Start Date

January 5 2024

End Date

September 3 2024

Last Update

September 23 2024

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Nu

London, United Kingdom