IDDSI Nutritional Drink for Dysphagia Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-28

Study Completion Date

2025-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dysphagia Malnutrition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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IDDSI nutritional supplement drink

Single arm designed, 28day on IDDSI nutritional supplement drink

Group Type EXPERIMENTAL

IDDSI nutritional supplement drink

Intervention Type DIETARY_SUPPLEMENT

ready-to-use nutritional supplement drink to be taken daily for 28 days

Interventions

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IDDSI nutritional supplement drink

ready-to-use nutritional supplement drink to be taken daily for 28 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No