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INGEST: dIscontinuing or continuiNG thickEned fluidS Trial

The clinical and cost effectiveness of discontinuing thickened fluids compared to continuing thickened fluids in adults with slowly progressing oropharyngeal dysphagia.

Background

Dysphagia is the medical term for difficulty swallowing. It can occur at any stage of the swallowing process, from the mouth down to the stomach. Dysphagia can be mild, causing, for example, a feeling that food is "sticking" in the throat, or severe, potentially leading to choking or an inability to swallow at all. There are two main types of dysphagia. Oropharyngeal dysphagia affects the mouth and throat, occurring when a person has difficulty moving the food or fluid to the back of the mouth and starting the swallowing process. It may result from neurological issues, such as a stroke, Parkinson's disease, or multiple sclerosis, affecting the muscles and nerves involved in swallowing. Oesophageal dysphagia occurs when there is a problem in the oesophagus, often due to a physical blockage (like a stricture or tumour) or motility disorder, where the muscles of the oesophagus do not contract properly. This study is concerned only with oropharyngeal dysphagia (hereafter referred to as dysphagia). Thickened fluids are a commonly used intervention for people with dysphagia as their properties mean they transit the swallow mechanism more slowly compared to thin fluids. This allows more time for the airway protection mechanisms to avoid fluids entering the airway and potentially reaching the lungs. 
However, the evidence supporting the use of thickened fluids in reducing aspiration-related respiratory infections is limited and inconclusive, particularly when considering long-term health outcomes such as dehydration. Patient preference and quality of life are additional factors that call into question the routine use of thickened fluids. Several studies have demonstrated that individuals with dysphagia often find thickened fluids unpalatable, which negatively affects their emotional well-being and social engagement. The lack of clear information relating to the benefits and risks of thickened liquids negatively impacts the ability of healthcare practitioners, patients and their advocates to make an informed decision about whether or not to commence, continue or discontinue the intervention.

Aims and objectives

The aim of this study is to determine the clinical and cost effectiveness of discontinuing thickened fluids compared to continuing thickened fluids in adults with slowly progressing oropharyngeal dysphagia.
Objectives:

  • Explore whether discontinuing thickened fluids improves quality of life;
  • Undertake a 7-month internal pilot to confirm the feasibility of recruitment;
  • Estimate the difference between groups for a range of secondary outcomes;
  • Conduct a cost-utility analysis;
  • Undertake a nested qualitative study to inform trial processes, acceptability and fidelity of the intervention and optimisation of discontinuation.

Methods

Multicentre, randomised controlled trial with internal pilot, economic evaluation and nested qualitative study. Data will be collected at baseline, 6 weeks and 3, 6 and 12 months. The primary outcome is the Swallowing Quality of Life (SWAL-QOL) questionnaire at 6 weeks. Secondary outcomes include SWAL-QOL total and domain scores, any pneumonia incidence, hydration, nutritional status, body weight, mental health, health-related quality of life, resource use, mealtime performance and adherence, patient/carer acceptability and fidelity to discontinuation protocol, carer burden, adverse events, side effects and mortality.

  • Target population: Adults aged 18 years and over with slowly progressing dysphagia caused by any health condition, receiving thickened fluids for at least a month and expected to continue, receiving any consistency of fluid, under the care of a SLT and who are living in the community.
  • Control: Continuation of the use of thickened fluids as prescribed.
  • Intervention: Discontinuation of the use of commercial thickener added to fluids will be implemented through two linked discontinuation protocols, one targeting SLTs and formal carers and a second targeting patients and family members.
  • Sample size: 366 participants will be randomised 1:1. Estimated recruitment period: 21 months
  • Duration per participant: 12 months

Study Status

The study is currently in set up. We are due to start recruitment in November 2026.

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Funding

Funders(s): NIHR Health Technology Assessment (NIHR170347)
Start Date: February 2026
End Date: January 2030

Members

YTU Team

External Team

  • Dr Lindsey Collins, Associate Professor in the Centre for Applied Dementia Studies and Co Chief Investigator
  • Dr Jae Hargen, PPI Lead, University of Bradford
  • Daniel Kelleher, Demetia Care Trainer, University of Bradford
  • Clare Mason, Assistant Professor – Demetia Care Trainer & Patient and Public Involvement Lead, University of Bradford
  • Dr Chinasa Odo, Research Fellow, University of Bradford
  • Andrew Key, Centre Co-ordinator, University of Bradford
  • Dr Mark Jayes, Research Fellow in Communication Disability, Manchester Metropolitan University
  • Amit Kulkarni, Head of Research and Outcomes, Royal College of Speech and Language Therapists
  • Associate Professor Roganie Govender, University College London Hospitals NHS Foundation Trust
  • Professor Rebecca Lawton, Professor – Psychology of Healthcare, University of Leeds
  • Professor David Smithard, Consultant in Acute Frailty, Lewisham and Greenwich NHS Trust
  • Mrs Tracy Lazenby-Paterson, Speech and Language Therapy Team Lead, Intellectual (Learning) Disabilities Service, NHS Scotland

Contact Us

Email: ytu-ingest-trial@york.ac.uk