IDDSI Level 2 ONS study - IDDSIL2
Research type
Research Study
Full title
An evaluation of the tolerance, compliance, acceptability and safety of a new oral nutritional supplement in dysphagic patients
IRAS ID
242428
Contact name
Rebecca Stratton
Contact email
Sponsor organisation
Nutricia Ltd
Duration of Study in the UK
2 years, 8 months, 31 days
Research summary
Some patients may not be able to swallow normal textures and consistencies of food and drinks - this is called “dysphagia”. Patients may need specific textures and thicknesses of foods and fluids to reduce the risk of them choking or getting food and drink into their lungs. Without appropriate management of swallowing problems and nutrition, this may lead to reduced nutritional intake and risk of malnutrition. Oral nutritional supplements (ONS) are commonly used to meet the nutritional requirements of patients with disease-related malnutrition and these are also available in different levels of thickness for patients with swallowing problems. A qualified healthcare professional will advise if a patient needs to have thickened drinks and how to do this. A new international framework has been developed which aims to explain all the different levels for drinks and food modification (levels 0-7) for patients with swallowing problems worldwide.\n\nNutricia is a medical nutrition company and has developed a ready-to-use pre-thickened oral nutritional supplement suitable for patients needing mildly thick (IDDSI level 2) fluids who are struggling to meet their nutritional needs. This is available as a 125ml bottle in Vanilla or Strawberry flavour.\n\nThe study will investigate the gastrointestinal tolerance, compliance, acceptability and safety of the mildly thick (IDDSI level 2) ready-to-use milkshake style oral nutritional supplement in 40 adult patients with dysphagia requiring oral nutritional support in several NHS sites across England and Wales.\n\nPatients will be asked to take the study supplement for 28 days, in a quantity advised by their Dietitian. Data will be recorded using questionnaires with no invasive measures. The primary outcome is gastrointestinal tolerance with secondary outcomes of compliance, acceptability, safety, nutrient intake and anthropometry.\n\nNutricia will fund the research. The oral nutritional supplement drink is a Food for Special Medical Purposes and MHRA exempt (please see attached MHRA exemption letter).\n
REC name
London - Bromley Research Ethics Committee
REC reference
18/LO/0465
Date of REC Opinion
26 Mar 2018
REC opinion
Unfavourable Opinion