Study to Assess the Acceptability of Fresubin® Plant-Based Drink

• Research type

  Research Study

• Full title

  Acceptability Study to Assess the Tolerance, Compliance and Palatability of Fresubin® Plant-Based Drink.

• IRAS ID

  337055

• Contact name

  Rachel Walker

• Contact email

  rachel.walker@fresenius-kabi.com

• Sponsor organisation

  Fresenius Kabi Ltd

• Duration of Study in the UK

  0 years, 3 months, 3 days

• Research summary

  The purpose of the study is to investigate the gastro-intestinal (GI) tolerance and acceptability (sensory qualities / volume consumed) of Fresubin® Plant-Based Drink (a high energy, high protein, oral nutritional supplement (ONS)) in patients requiring supplementary oral nutritional support.

  It is of relevance to patients, healthcare professionals (HCP) and the general public as it provides the required data needed to be submitted to the Advisory Committee on Borderline Substances (ACBS). The ACBS (UK Department of Health and Social Care - reimbursement) are the governing body that make the decision whether an ONS can be prescribed in the community in the UK.

  The process is detailed at: https://assets.publishing.service.gov.uk/government/uploads/syste
  m/uploads/attachment_data/file/792998/Appendix5.pdf

  The study will be carried out in patients ≥ 18 years of age that require nutritional supplementation who are able to consent. Following recruitment to the study, relevant medical/nutritional information will be recorded, along with baseline GI tolerance data. Patients height, weight and BMI will be measured at the start of the study.

  Patients will then change to / start Fresubin® Plant-Based Drink for a period of 30 days in the intervention period. GI tolerance will be recorded daily for the first 7 days and compliance data (how much of the supplement was taken) will be recorded throughout the duration of the intervention period (30 days). An acceptability and preference questionnaire will be completed at the end of the intervention.

  Fresenius Kabi Ltd. will fund this research. The ONS is a Food for Special Medical Purposes (FSMP) and is MHRA exempt.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  24/LO/0167

• Date of REC Opinion

  7 May 2024

• REC opinion

  Further Information Favourable Opinion