DysphagiaNCT03679078
IDDSI Nutritional Drink for Dysphagia Study
A study testing IDDSI nutritional supplement drink in people with Dysphagia and Malnutrition, run by Nutricia UK Ltd at 8 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Malnutrition
- What is being tested?
- IDDSI nutritional supplement drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 28 Aug 2018to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Aneurin Bevan University Health Board
Caerleon, NP16 3XQ
Cambridge University Hospitals NHS Foundation Trust
Cambridge
Dudley Group NHS Trust
Dudley
Cwm Taf University Health Board
Llwynypia
Croydon Health NHS Trust
London
Lewisham and Greenwich NHS Foundation Trust
London
Great Western Hospitals NHS Foundation Trust
Swindon
Weston Area Health Trust
Weston-super-Mare
About this study
Official title: An Evaluation of the Tolerance, Compliance, Acceptability and Safety of a New Oral Nutritional Supplement in Dysphagic Patients
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.
Read the 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.
- Conditions
- Dysphagia, Malnutrition
- Being tested
- IDDSI nutritional supplement drink
- Medical subject headings
- Deglutition Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDDSI nutritional supplement drinkDietary supplement
ready-to-use nutritional supplement drink to be taken daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| IDDSI nutritional supplement drink | Experimental | Single arm designed, 28day on IDDSI nutritional supplement drink Receives: Dietary Supplement: IDDSI nutritional supplement drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Tolerance
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.
Measured: Day 1, Day 2, Day 3, Day 10, Day 17, Day 24 and Day 31
Secondary outcomes (5)
Compliance
Daily questionnaire on amount of nutritional drink prescribed and amounts actually consumed. Amount of daily ONS actually consumed scale minimum = 0%, maximum = 100%
Measured: Once during baseline period (Day 1) and then daily through intervention period (Days 4-31)
Acceptability: Brief tick-box questionnaire
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
Measured: Day 1, Day 17, Day 31
Anthropometry
Measurements of height and weight with Body Mass Index (BMI) calculated at baseline and end of study.
Measured: Day 1 and Day 31
Nutrient intake
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.
Measured: Day 1, Day 17 and Day 31
Safety (Adverse events reporting)
Reporting of any adverse events that occur throughout study.
Measured: 31 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start28 Aug 2018
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Why it stopped: Project suspended whilst intervention is updated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Stratton, Dr, Study director, Nutricia Ltd UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679078
- Sponsor's protocol ID
- IDDSIL2
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 2018
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Tolerance, Compliance, Acceptability and Safety of a New Oral Nutritional Supplement in Dysphagic Patients
- ClinicalTrials.gov ID
- NCT03679078
- Acronym / sponsor ID
- IDDSIL2
- Conditions
- Dysphagia, Malnutrition
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Project suspended whilst intervention is updated
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nutricia UK LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IDDSI nutritional supplement drink | Experimental | Dietary Supplement: IDDSI nutritional supplement drinkSingle arm designed, 28day on IDDSI nutritional supplement drink |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDDSI nutritional supplement drinkready-to-use nutritional supplement drink to be taken daily for 28 days | Dietary supplement | IDDSI nutritional supplement drink |
Primary outcome
Gastrointestinal Tolerance
Time frame: 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.
5 secondary outcomes
Compliance
Time frame: Once during baseline period (Day 1) and then daily through intervention period (Days 4-31)
Acceptability: Brief tick-box questionnaire
Time frame: Day 1, Day 17, Day 31
Anthropometry
Time frame: Day 1 and Day 31
Nutrient intake
Time frame: Day 1, Day 17 and Day 31
Safety (Adverse events reporting)
Time frame: 31 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Stratton, Dr study director
Nutricia Ltd UK
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IDDSI nutritional supplement drink in people with Dysphagia and Malnutrition, run by Nutricia UK Ltd at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Tolerance (time frame: Day 1, Day 2, Day 3, Day 10, Day 17, Day 24 and Day 31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.