Clinical trial NCT03679078: IDDSI Nutritional Drink for Dysphagia Study
Official title: An Evaluation of the Tolerance, Compliance, Acceptability and Safety of a New Oral Nutritional Supplement in Dysphagic Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Dysphagia
Malnutrition
Lead sponsor: Nutricia UK Ltd
Sponsor class: INDUSTRY
First posted: 2018-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will evaluate the gastrointestinal (GI) tolerance, compliance , acceptability and safety of a ready-to-use oral nutritional supplement drink for patients with dysphagia.

Detailed description: Dysphagia is a complex condition common in a number of diagnoses including stroke, Parkinson's disease, head and neck cancer, dementia, learning disabilities and gastric/oesophageal motility disorders.

A modified textured diet and/or fluid is considered as an effective intervention in management of dysphagia. The International Dysphagia Diet Standardisation Initiative (IDDSI) have developed a new framework around the terms and descriptors used in the management of individuals with dysphagia. Malnutrition is very common in patients with dysphagia and the use of pre-thickened oral nutritional supplements (ONS) has been found as an effective way to manage this. However, due to impairment in the swallow process, dysphagic patients require pre-thickened oral nutritional supplement to ensure safe consumption of these nutritional supplements.

40 participants, requiring a new pre-thickened oral nutritional supplement in line with the new IDDSI framework recruited from hospitals, outpatients clinics, care homes, community hospitals, community dietetic/speech and language therapy services or stroke rehabilitation units will receive the ready-to-use oral nutritional supplement for a 4 week intervention period. This study aims to primarily evaluate gastro-intestinal tolerance, with secondary outcomes including compliance, acceptability, nutrient intake, anthropometry and safety.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Age ≥ 18 years
* Patients with a requirement for ≥ 250kcal/day from a milkshake style ONS for ≥ 4 weeks or current users of ONS
* Patients identified to require mildly thick (IDDSI level 2) fluids.
* Patients competent to provide written informed consent and able to answer questions
* Patients able to take study ONS orally

Exclusion Criteria:

* Patients that lack capacity to provide informed consent
* Patients that are unable to take study ONS orally
* Participants with chronic renal disease requiring dialysis
* Participants with liver failure
* Participants that are pregnant or lactating
* Participation in other studies that may interfere with this study
* Participants receiving 100% total nutritional requirements from tube feeding or parenteral nutrition
* Patients with galactosaemia or lactose intolerance
* Patients receiving palliative or end of life care

Primary outcomes:
measure: Gastrointestinal Tolerance
timeFrame: Day 1, Day 2, Day 3, Day 10, Day 17, Day 24 and Day 31
Secondary outcomes:
measure: Compliance
timeFrame: Once during baseline period (Day 1) and then daily through intervention period (Days 4-31)
measure: Acceptability: Brief tick-box questionnaire
timeFrame: Day 1, Day 17, Day 31
measure: Anthropometry
timeFrame: Day 1 and Day 31
measure: Nutrient intake
timeFrame: Day 1, Day 17 and Day 31
measure: Safety (Adverse events reporting)
timeFrame: 31 days.
Other outcomes:
Locations:
city: Caerleon
country: United Kingdom
facility: Aneurin Bevan University Health Board
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Dudley
country: United Kingdom
facility: Dudley Group NHS Trust
city: Llwynypia
country: United Kingdom
facility: Cwm Taf University Health Board
city: London
country: United Kingdom
facility: Croydon Health NHS Trust
city: London
country: United Kingdom
facility: Lewisham and Greenwich NHS Foundation Trust
city: Swindon
country: United Kingdom
facility: Great Western Hospitals NHS Foundation Trust
city: Weston-super-Mare
country: United Kingdom
facility: Weston Area Health Trust
Study officials:
affiliation: Nutricia Ltd UK
name: Rebecca Stratton, Dr
role: STUDY_DIRECTOR
References: