Clinical trial NCT06102122: Acceptability and Tolerance Study of Adult Tube Feed with Food with Food Derived Ingredients.
Official title: To Evaluate the Acceptability (including Gastrointestinal Tolerance and Compliance) of an Adult Tube-feed Formula with Ingredients Derived from Food.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Exposure
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2023-10-26
Enrollment: 18
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Primary outcomes:
measure: Daily record via participant diary
timeFrame: 7 days
measure: Formula intake diary
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Tanita Flood
Study officials:
affiliation: Royal Hospital for Neuro-disability
name: Tanita Flood
role: PRINCIPAL_INVESTIGATOR
affiliation: Community Paediatric Dietitian Worcestershire, Hastings UK
name: Martha Van der Linde
role: PRINCIPAL_INVESTIGATOR
affiliation: Barts and London Hospital Trust London UK
name: Minal Patel
role: PRINCIPAL_INVESTIGATOR
affiliation: Newham General Hospital London UK
name: Adrian Gilson
role: PRINCIPAL_INVESTIGATOR
References: