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

Dietary Exposure Clinical Trial

Official title:

To Evaluate the Acceptability (Including Gastrointestinal Tolerance and Compliance) of an Adult Tube-feed Formula With Ingredients Derived From Food.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06102122
• Other study ID #: Compleat 001
• Status: Completed
• Phase: N/A
• Start date: August 22, 2023
• Est. completion date: December 22, 2023

Study information

• Verified date: April 2024
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 22, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Exposure

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Tanita Flood	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	Daily record via participant diary	Daily Gastrointestinal diary as questionnaire, increase, decrease or no change	7 days
Primary	Formula intake diary	mL per day	28 days