IDDSI Nutritional Drink for Dysphagia Study

Nutricia

Status

Suspended

Conditions

Dysphagia

Malnutrition

Treatments

Dietary Supplement: IDDSI nutritional supplement drink

Study type

Interventional

Funder types

Industry

Identifiers

NCT03679078

IDDSIL2

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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