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

NCT06102122 | Completed

• 1 other identifier: Compleat 001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dietary Exposure

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

OTHER

Patients will switch from current to new tube feed.

Dietary Supplement: Compleat

Interventions

Compleat DIETARY_SUPPLEMENT

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

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Tanita Flood

London, United Kingdom

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Adrian Gilson

  Newham General Hospital London UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: October 26, 2023
• Study Start: August 22, 2023
• Primary Completion: September 15, 2023
• Study Completion: December 22, 2023
• Last Updated: September 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)