IDDSI Nutritional Drink for Dysphagia Study

Sponsor
Nutricia UK Ltd (Industry)
Overall Status
Suspended
CT.gov ID
NCT03679078
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: IDDSI nutritional supplement drink
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
An Evaluation of the Tolerance, Compliance, Acceptability and Safety of a New Oral Nutritional Supplement in Dysphagic Patients
Actual Study Start Date :
Aug 28, 2018
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: IDDSI nutritional supplement drink

Single arm designed, 28day on IDDSI nutritional supplement drink

Dietary Supplement: IDDSI nutritional supplement drink
ready-to-use nutritional supplement drink to be taken daily for 28 days

Outcome Measures

Primary Outcome Measures

  1. Gastrointestinal Tolerance [Day 1, Day 2, Day 3, Day 10, Day 17, Day 24 and Day 31]

    Gastro-intestinal tolerance will be assessed daily throughout a 3 day baseline period before starting the study ONS and at the end of each week (day 10, day 17, day 24, day 31) using a standardised GI tolerance questionnaire including questions on number of bowel movements per day, other gastrointestinal symptoms such as flatulence, bloating, burping and abdominal discomfort. Patient-reported gastrointestinal symptoms with scale range for each symptom as s scale range minimum = none, maximum = severe. Change of symptom from baseline scale minimum = no change, maximum = worse.

Secondary Outcome Measures

  1. Compliance [Once during baseline period (Day 1) and then daily through intervention period (Days 4-31)]

    Daily questionnaire on amount of nutritional drink prescribed and amounts actually consumed. Amount of daily ONS actually consumed scale minimum = 0%, maximum = 100%

  2. Acceptability: Brief tick-box questionnaire [Day 1, Day 17, Day 31]

    Brief tick-box questionnaire on overall liking and acceptability of product, including texture and feel of nutritional drink, flavor and ease of use. Scale minimum = dislike very much, maximum = like very much Scale minimum = very inconvenient, maximum = very convenient Scale minimum = very difficult, maximum = very easy

  3. Anthropometry [Day 1 and Day 31]

    Measurements of height and weight with Body Mass Index (BMI) calculated at baseline and end of study.

  4. Nutrient intake [Day 1, Day 17 and Day 31]

    Three dietary recalls relating to the the past 24 hours of Day 1, Day 17 and Day 31 to capture all food and fluids consumed. This will subsequently be analysed in dietary software.

  5. Safety (Adverse events reporting) [31 days.]

    Reporting of any adverse events that occur throughout study.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aneurin Bevan University Health Board Caerleon United Kingdom NP16 3XQ
2 Cambridge University Hospitals NHS Foundation Trust Cambridge United Kingdom
3 Dudley Group NHS Trust Dudley United Kingdom
4 Cwm Taf University Health Board Llwynypia United Kingdom
5 Croydon Health NHS Trust London United Kingdom
6 Lewisham and Greenwich NHS Foundation Trust London United Kingdom
7 Great Western Hospitals NHS Foundation Trust Swindon United Kingdom
8 Weston Area Health Trust Weston-super-Mare United Kingdom

Sponsors and Collaborators

  • Nutricia UK Ltd

Investigators

  • Study Director: Rebecca Stratton, Dr, Nutricia Ltd UK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nutricia UK Ltd
ClinicalTrials.gov Identifier:
NCT03679078
Other Study ID Numbers:
  • IDDSIL2
First Posted:
Sep 20, 2018
Last Update Posted:
Apr 20, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2022