Acceptability and Tolerance Study of Adult Tube Feed with Food with Food Derived Ingredients.

To Evaluate the Acceptability (including Gastrointestinal Tolerance and Compliance) of an Adult Tube-feed Formula with Ingredients Derived from Food.

Product acceptability data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service Executive (HSE) submission for Ireland for product registration.

Study Overview

• Status: Completed
• Conditions: Dietary Exposure
• Intervention / Treatment: Dietary supplement: Compleat

Detailed Description

To evaluate the acceptability (including gastrointestinal tolerance and compliance) of an adult tube-feed formula with ingredients derived from food for the dietary management of participants who require a tube feed. .

The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service

Executive (HSE) for Ireland. Participants will be provided with one month supply of 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 volumes

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Tanita Flood

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Require a tube feed (taking >75% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition
• Adults and children requiring an adult enteral formula as assessed by the dietitian.
• Patients well-established and stable on a standard formula or currently on Isosource® Junior Mix.
• Willingly given, written, informed consent from patient or consultee. For those who lack capacity to provide formal consent for themselves, this may be provided by a personal or consultee in accordance with the Mental Capacity Act.
• Willingly given, written assent (if appropriate) on behalf of patients under 18.

Exclusion Criteria:

• Inability to comply with the study protocol, in the opinion of the investigator
• Known food allergies to any ingredients (see ingredients list)
• Patients with significant renal or hepatic impairment - Change in current medication or use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file).
• Participation in another interventional study within 2 weeks of this study.

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; Patients will switch from current to new tube feed.	Dietary supplement: Compleat; Patients well established and stable on a standard enteral tube feed with food derived ingredients will act as their own controls and make a product switch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily record via participant diary	Daily Gastrointestinal diary as questionnaire, increase, decrease or no change	7 days
Formula intake diary	mL per day	28 days

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Adrian Gilson, Newham General Hospital London UK; Principal Investigator: Tanita Flood, Royal Hospital for Neuro-disability; Principal Investigator: Martha Van der Linde, Community Paediatric Dietitian Worcestershire, Hastings UK; Principal Investigator: Minal Patel, Barts and London Hospital Trust London UK

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2023
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 26, 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: Compleat 001

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 Time Frame: At the end of the study full abstract and publication to be made avaliable.
• 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