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

Nestlé

Status

Completed

Conditions

Dietary Exposure

Treatments

Dietary Supplement: Compleat

Study type

Interventional

Funder types

Industry

Identifiers

NCT06102122

Compleat 001

Details and patient eligibility

About

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.

Full 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

Enrollment

18 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.