Tolerance and Acceptability Evaluation of AYMES AMSTERDAM V1

• Research type

  Research Study

• Full title

  Tolerance and Acceptability Evaluation of AYMES AMSTERDAM

• IRAS ID

  251373

• Contact name

  Angie Jefferson

• Duration of Study in the UK

  0 years, 0 months, 29 days

• Research summary

  The purpose of this study is to investigate the tolerance (bowel movements / gastro-intestinal (GI) side effects) and compliance and acceptability (sensory qualities/volume) of AYMES AMSTERDAM (a high energy oral nutritional supplement (ONS)) in patients requiring supplementary oral nutritional support. It is of relevance to patients, health care professionals (HCP) and the general public as it provides data which can be submitted to the Advisory Committee on Borderline Substances (ACBS). The ACBS is the governing body that makes the decision whether or not an ONS can be prescribed in the community at the expense of the NHS.\n\nParticipants will be adults over the age of 18 years, assessed to have or to be at risk of malnutrition (as determined by the Malnutrition Universal Screening Tool (MUST,)) requiring nutritional supplementation for at least 7 days. Patients suitable will be those residing in community settings.\n\nThe investigator will recruit participants by approaching care homes to identify potential participants. With consent taken, participants relevant medical and dietary history will be reviewed. Participants’ height and weight is measured and body mass index (BMI) calculated on day 1. Baseline GI tolerance and bowel movement data and dietary intake are recorded for 3 days. \n\nParticipants will then commence on AYMES AMSTERDAM ONS on day 4 for 7 days (intervention period.) Tolerance and bowel movement data (as above) will be recorded, along with compliance (how much of ONS was prescribed/taken). One 3 day food diary is kept during this period (days 8 - 10) and bodyweight is measured on day 10. \n\nAcceptability and preference questionnaire is completed by participants at the end of the study.

• REC name

  London - Surrey Research Ethics Committee

• REC reference

  19/LO/0526

• Date of REC Opinion

  25 Mar 2019

• REC opinion

  Favourable Opinion