Status:
COMPLETED
Acceptability and Tolerance Study of Adult Tube Feed with Food with Food Derived Ingredients.
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Dietary Exposure
Eligibility:
All Genders
16+ years
Phase:
NA
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) submissi...
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 requ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06102122
Start Date
August 22 2023
End Date
December 22 2023
Last Update
September 23 2024
Active Locations (1)
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1
Tanita Flood
London, United Kingdom