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

Study Overview
=================
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.

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

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

Conditions
-----------------
Dietary Exposure

Intervention / Treatment
-----------------
* Dietary Supplement: Compleat


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients well established on tube feeds will act as their own control<br>Patients will switch from current to new tube feed. | Dietary Supplement: Compleat<br>* 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<br>|

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 |