ESj-powder complete T&A study V3
Research type
Research Study
Full title
Evaluation of Tolerance & Acceptability of EnergieShake Junior Powder Complete
IRAS ID
283223
Contact name
Chris Smith
Contact email
Sponsor organisation
Garvey-Consulting
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
It is important to establish acceptance (compliance, palatability/taste) and tolerance of ORAL NUTRITIONAL SUPPLEMENTS (ONS) designed for children before they are made available on prescription. The Advisory Committee of Borderline Substances (ACBS) proposed that all products that are to be made available on prescription in the UK should first demonstrate “acceptability” and “tolerance” in the target population “for whom it is intended” (ACBS 2019: EC Directive 2001 / 20 / EC) – for “/formulations that are broadly similar in composition to existing products already on the market” (ACBS 2019). The ACBS is the organisation responsible for advising on the prescription of borderline substances for use in the UK, including ONS. The test product is considered broadly similar to existing product on the market in the UK.
The purpose of this study is to demonstrate that the test product (EnergieShake® Jr Powder Complete)- designed for children is accepted by children (i.e. they take the amount prescribed by their doctor or dietitian [compliance] and it is accepted [considered palatable]), and is tolerated by children (i.e. does not cause additional gastrointestinal problems). The ACBS criteria for “acceptability” and “tolerance” studies specifies that they are performed in at least 15 children, be at least 1 week long (7 days) with specific information gathered on gastrointestinal tolerance, palatability & compliance. To establish acceptability and tolerance it is recommended to compare the child’s intake of the test product with intake of their current ONS (baseline data). This is collected for 2 days. The intervention phase when the child takes the test product is an additional 7 days. Data is completed in a daily diary. Only children who are currently taking ONS “broadly similar in formulation” (prescribed by a dietitian/doctor) are considered eligible to join this study. Once the data collection is completed it will be written up as a report, and be submitted to the ACBS for review.REC name
South East Scotland REC 01
REC reference
20/SS/0053
Date of REC Opinion
4 Jun 2020
REC opinion
Further Information Favourable Opinion