ESj-powder complete T&A study

  • Research type

    Research Study

  • Full title

    Evaluation of Tolerance & Acceptability of EnergieShake Junior Powder Complete

  • IRAS ID

    281206

  • Contact name

    Chris Smith

  • Contact email

    chris.smith53@nhs.net

  • Sponsor organisation

    Garvey-Consulting

  • Duration of Study in the UK

    0 years, 4 months, 5 days

  • Research summary

    It is believed that the acceptance and tolerance of ORAL NUTRITIONAL SUPPLEMENTS (ONS) achieves better compliance, which can help children gain weight and grow. The purpose of this study is to test whether EnergieShake® Jr Powder Complete (a new powdered ONS designed for children) is accepted by children (i.e. they take the amount recommended by their doctor or dietitian and like the taste), and is tolerated by children (i.e. does not cause them gastrointestinal problems). It will be compared with the child's current ONS intake in terms of acceptance and tolerance which is recorded at baseline. The total study period is 9 days. 2 days for the baseline data collection, and 7 days of intervention when the child will consume the new (test) product. Following completion of the study it will be written up as a report, to be submitted to the Advisory Committee of Borderline Substances (ACBS). This is the organisation responsible for advising on the prescribing of borderline substances for use in the NHS.

  • REC name

    East Midlands - Leicester Central Research Ethics Committee

  • REC reference

    20/EM/0095

  • Date of REC Opinion

    9 Apr 2020

  • REC opinion

    Unfavourable Opinion