Acceptability and Tolerance Study of a High Energy Tube Feed with Food Derived Ingredients

Acceptability (including Gastrointestinal Tolerance and Compliance) of a High Energy, Adult Enteral Formula with Food-derived Ingredients.

Enterally fed adults and children who are assessed by the dietitian as requiring an adult high-energy, fibre-containing enteral formula will be recruited. Data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.

Study Overview

• Status: Completed
• Conditions: Tolerance
• Intervention / Treatment: Dietary supplement: Compleat 1.5 HP

Detailed Description

To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a high energy, adult enteral formula with food-derived ingredients.This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 14-day period with the new tube feed.

Participants or their caregivers will be provided with 14-day supply of the new tube feed and will be asked to complete a daily diary and short questionnaire to record information allowing assessment of the following:

• Gastrointestinal tolerance
• Compliance with prescribed feed volume

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Worcester, United Kingdom
    • Martha Van Der Linde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients requiring an enteral tube feed (taking > 60% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition

  • Children 15 years and over
  • Adults and children requiring an adult high-energy and fibre-containing formula, as assessed by the dietitian.
  • Patients well-established and stable on enteral feeding.
  • Willingly given, written, informed consent from patient or consultee
  • Willingly given, written assent (if appropriate).

Exclusion Criteria:

• Inability to comply with the study protocol, in the opinion of the investigator

  • Children under 15 years of age
  • Patients receiving mechanical ventilation, sedation or inotropic support
  • Patients on total parenteral nutrition
  • Known food allergies to any ingredients (see ingredients list) or galactosaemia
  • Patients with significant renal or hepatic impairment
  • Patients with planned changes to medication or treatments during the study period which may alter gastrointestinal function (e.g. chemotherapy). Changes in medications or nutritional products during the study intervention must be documented.
  • Participation in another interventional study within 2 weeks of this study.
  • Patients with a clinical indication for a low fibre or fibre free diet as advised by the healthcare team.
  • Patients with known or suspected ileus or mechanical bowel obstruction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients well established on tube feeds will act as their own control; These patients will switch from current to new tube feed to assess acceptability and tolerance	Dietary supplement: Compleat 1.5 HP; Patients well established and stable on an enteral tube feed. This group will act as their own controls and switched to the new tube feed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily patient diaries	Daily monitor of gastrointestinal tolerance using questionnaire on increase, decrease or no change	14 days
Daily formula intake	mL per day	14 days

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Martha Van Der Linde, Community Paediatric Dietitian Worcestershire North Nutrition and Dietetic Hastings Way, Worcester. UK; Principal Investigator: Amy Carter, The Walton Centre NHS Foundation Trust, Liverpool UK; Principal Investigator: Sam Ogundere, Lewisham and Greenwich NHS Trust London UK; Principal Investigator: Adrian Gilson, Newham General Hospital London UK

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Actual): August 21, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Compleat002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: will upload the data as it becomes available
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No