MalnutritionNCT05257980
Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial
A study testing Dietary supplement (ONS) in people with Malnutrition, run by Nutricia UK Ltd at 19 sites in United Kingdom.
Trial summary
The aim of this study is to evaluate compliance, acceptability, gastrointestinal tolerance, nutrient intake, appetite, nutritional status, and safety of four new ready to drink ONS. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Dietary supplement (ONS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 19 sitesUnited Kingdom
- Study dates
- 27 Sep 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female
- ≥16 years of age
- Identified as being malnourished/at risk of malnutrition by malnutrition screening tools [i.e., MUST score ≥1, and/or using or requiring ONS at least once daily as part of nutritional management plan]
- Expected to receive at least one bottle of ONS per day
- Written or electronic informed consent from patient, or verbally given consent countersigned by a witness for those physically unable to sign
Who cannot join
- Patients receiving parenteral nutrition or ≥70% total energy requirements from enteral tube feeding
- Patients with major hepatic dysfunction (i.e., decompensated liver disease)
- Patients with major renal dysfunction [i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD)]
- Cancer patients likely to anticipate significant gastrointestinal disturbances/taste changes as a result of Systemic Anti-Cancer Therapy (SACT)
- Patients with active/chronic gastrointestinal disease or impaired gastrointestinal function
- Patients with significant dysphagia/high aspiration risk
Show all 10Show fewer
- Participation in other clinical intervention studies within 1 month of this study
- Adults lacking mental capacity to consent
- Allergy to any study product ingredients
- Investigator concern regarding ability or willingness of patient to comply with the study requirements.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United Kingdom19 sites
Ashford and St Peter's Hospitals NHS Foundation Trust
Ashford
West Walk Surgery
Bristol
Rowden Surgery
Chippenham
Sirona Care & Health
Clevedon
Mountainhall Treatment Centre
Dumfries
Royal Surrey NHS Foundation Trust
Guildford
Preston Hill Surgery
Harrow
Honiton Surgery
Honiton
James Alexander Family Practice
Hull
NHS Highland
Inverness
Airedale NHS Foundation Trust
Keighley
Kings Cross Hospital
London
Northumbria Healthcare NHS Foundation Trust
Newcastle
Norfolk Community Health and Care NHS Trust
Norwich
Nottingham University Hospitals NHS Trust
Nottingham
Glan Clwyd Hospital
Rhyl
Trowbridge Health Centre
Trowbridge
Cowplain Family Practice
Waterlooville
Yeovil District Hospital
Yeovil
About this study
Official title: Evaluation of Four New Ready to Drink Oral Nutritional Supplements for the Management of Disease-related Malnutrition in Adults.
The aim of this study is to evaluate compliance, acceptability, gastrointestinal tolerance, nutrient intake, appetite, nutritional status, and safety of four new ready to drink ONS. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period. During the intervention period, patients will receive one of the four ONS for 28 days alongside their routine diet.
Read the detailed description
Disease-related malnutrition (DRM) is a highly prevalent condition which leads to significant adverse health and economic burden. For the management of patients with DRM, oral nutritional supplements (ONS) are recommended and often prescribed (typically 1-3/day). ONS are energy- and nutrient-dense feeds that provide macro and micro-nutrients, designed to increase nutritional intake when diet alone is insufficient to meet daily nutritional requirements. The use of ONS has been shown to be effective for managing DRM by improving patient outcomes, including alleviating disease symptoms, aiding recovery from illness, regaining strength and improving quality of life, and reducing mortality. Additionally, the use of ONS has been reported to be cost effective in the healthcare setting due to reduced complications, fewer hospitalisations, and a reduced length of hospital stay.
An important outcome to enable ONS to be clinically and physiologically effective is compliance (i.e., how much the patient consumes relative to what is prescribed). Whilst good compliance to ONS in both hospital and community patients has been reported (78%), compliance in some patient groups has been reported to be as low as 35%. Poor compliance has been reported due to inability to consume the required volume, poor palatability, and taste fatigue. Furthermore, with increasing trends in plant-based food consumption and veganism, the lack of plant-based ONS may reduce compliance in vegan patients or those wishing to reduce animal-derived consumption for cultural or religious reasons. Consequently, there is a clear need for the development of different types of ONS which better cater both for patients with reported low compliance, but also patients with potentially higher compliance when presented with increased variety and choice.
The aim of this study is to evaluate compliance, acceptability, gastrointestinal tolerance, nutrient intake, appetite, nutritional status, and safety of four new ready to drink ONS. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period. During the intervention period, patients will receive one of the four ONS for 28 days alongside their routine diet.
- Conditions
- Malnutrition
- Being tested
- Dietary supplement (ONS)
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement (ONS)Dietary supplement
At baseline, the investigating dietitian/nurse will record several measures, including clinical history and symptoms over the previous 24 hours. In addition, patients who are already receiving an ONS will continue their prescribed ONS for 1 day in which their gastrointestinal tolerance, ONS compliance and acceptability will be recorded. All patients will then receive standardised dietary advice in addition to one of the four trial ONS products daily for 28 days. The type of ONS will be agreed with the patient and the investigating dietitian/nurse, and the ONS prescription will be determined on an individual basis by the investigating dietitian/nurse responsible for the patient's nutritional management (1-3 ONS per day; aligned with guidelines set out within the Malnutrition Pathway). The type of ONS prescribed will be the same throughout the 28 days and will be taken orally.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement (ONS) | Experimental | All patients will receive standardised dietary advice in addition to the ONS prescribed daily for 28 days. The ONS prescription will be determined on an individual basis by the investigating dietitian/nurse responsible for the patient's nutritional management (1-3 ONS per day; aligned with guidelines set out within the Malnutrition Pathway). The ONS prescribed will be the same throughout the 28 days and will be taken orally. Receives: Dietary Supplement: Dietary supplement (ONS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with ONS prescription
Compliance with ONS prescription (% of bottle and how many bottles consumed) will be assessed daily by recording how much of the product was prescribed, compared to the amount consumed by the patient. The amount prescribed by the investigating dietitian/nurse will be recorded at the start of the study and any changes to this prescription will also be noted. For patients already receiving an ONS prior to enrolling onto the study, compliance will be assessed for 1 day at baseline. For all patients, compliance with the intervention ONS prescription will be assessed daily throughout the study and will be recorded by the patient/carer. For analysis, the mean daily % and the mean daily number of bottles consumed over the 28 days will be used.
Measured: Baseline (Day 1) - End of the study (Day 29)
Secondary outcomes (10)
Nutrient Intake
At baseline (Day 1), and after 1 week (Day 8), and end of the intervention period (Day 29), the investigating dietitian/nurse will conduct a 24-hour dietary recall with the patient to record all food, drink and nutritional feeds provided in the 24 hours prior. This information will be entered into a dietary analysis software (Nutritics, Dublin, Ireland) for assessment of nutritional intake (i.e., total energy and macro- and micronutrients).
Measured: Baseline (Day 1) - End of the study (Day 29)
Acceptability
For patients already receiving an ONS prior to enrolling onto the study, acceptability of their currently prescribed ONS will be assessed for 1 day at baseline (Day 1). In all patients, acceptability of the prescribed intervention ONS will be assessed after 1 week (Day 8) and end of the intervention period (Day 29) using a questionnaire completed by the patient/carer. Questions will be rated on a 7-point Likert scale (Strongly Agree, Agree, Somewhat Agree, Neutral, Somewhat Disagree, Disagree, Strongly Disagree) and will relate to use, taste, aftertaste, thickness, and smell.
Measured: Baseline (Day 1) - End of the study (Day 29)
Gastrointestinal Tolerance
A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea) will be recorded at baseline (day 1) and at the end of each week (Days 8, 15, 22 and 29). Information about bowel movements will also be collected using the Bristol Stool Chart© at the same time points. The investigating dietitian/nurse will record usual GI symptoms at the baseline visit (Day 1; as reflective of the previous week) and if they are satisfied with the tolerance of the intervention feed at the end of the study (Day 29). The investigating dietitian/nurse will also assess any gastrointestinal tolerance goals for each patient.
Measured: Baseline (Day 1) - End of the study (Day 29)
Anthropometry
Historical weight will be recorded at baseline (Day 1), and current anthropometrics will be recorded upon screening, at baseline (Day 1) and at the end of the intervention period (Day 29) by the investigating dietitian/nurse. Body weight (kg) will be measured using standard methods to the nearest 0.1kg using a weighing scale without heavy clothing. Height will be measured at baseline only using standard measures to the nearest 0.1cm, without shoes or socks. Standardised methods to estimate height from segmental length (ulna length, knee height) will be used if standing height measurement is not possible. Height and weight measures will be used to calculate body mass index (BMI).
Measured: Baseline (Day 1) - End of the study (Day 29)
Nutritional Status
The risk of DRM will be assessed during screening (as inclusion criteria), and at baseline (Day 1), and at the end of the intervention period (Day 29) using MUST (Appendix 1). MUST is a five-step screening tool to identify adults who are at risk of DRM.
Measured: Baseline (Day 1) - End of the study (Day 29)
Dietetic Goal
A dietetic goal (e.g., weight increase/maintenance) will be set by the investigating dietitian/nurse at baseline (Day 1) for each patient. At the end of the intervention period (Day 29), the investigating dietitian/nurse will assess and note if the dietetic goal was met.
Measured: Baseline (Day 1) - End of the study (Day 29)
Appetite
Subjective appetite profile will be measured by the patient prior to breakfast on Day 2 (prior to beginning the intervention), and after 1 week (Day 8) and at the end of the intervention period (Day 29) by means of visual analogue scales (VAS) from 0 (not at all) to 10 (extremely).
Measured: Baseline (Day 1) - End of the study (Day 29)
Appetite (SNAQ)
Subjective appetite profile will be measured by the patient prior to breakfast on Day 2 (prior to beginning the intervention), and after 1 week (Day 8) and at the end of the intervention period (Day 29) by means of the Simplified Nutritional Appetite Questionnaire (SNAQ)
Measured: Baseline (Day 1) - End of the study (Day 29)
Medical and Dietetic History
Medical history, including diagnoses and prescribed medications as well as relevant dietetic history (previous feeding regimens) will be recorded at baseline (Day 1) and any changes during the intervention will be noted by the investigating dietitian/nurse throughout the study.
Measured: Baseline (Day 1) - End of the study (Day 29)
Adverse Events
Any adverse events will be recorded by the investigating dietitian/nurse.
Measured: Baseline (Day 1) - End of the study (Day 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start27 Sep 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Stratton, PhD, Study chair, Nutricia Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257980
- Sponsor's protocol ID
- ONS2021
- Status last verified
- Apr 2026
- First submitted
- 29 Sep 2021
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Evaluation of Four New Ready to Drink Oral Nutritional Supplements for the Management of Disease-related Malnutrition in Adults.
- ClinicalTrials.gov ID
- NCT05257980
- Acronym / sponsor ID
- ONS2021
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nutricia UK LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Feb 2022 (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.
The aim of this study is to evaluate compliance, acceptability, gastrointestinal tolerance, nutrient intake, appetite, nutritional status, and safety of four new ready to drink ONS. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period. During the intervention period, patients will receive one of the four ONS for 28 days alongside their routine diet.
Detailed description
Disease-related malnutrition (DRM) is a highly prevalent condition which leads to significant adverse health and economic burden. For the management of patients with DRM, oral nutritional supplements (ONS) are recommended and often prescribed (typically 1-3/day). ONS are energy- and nutrient-dense feeds that provide macro and micro-nutrients, designed to increase nutritional intake when diet alone is insufficient to meet daily nutritional requirements. The use of ONS has been shown to be effective for managing DRM by improving patient outcomes, including alleviating disease symptoms, aiding recovery from illness, regaining strength and improving quality of life, and reducing mortality. Additionally, the use of ONS has been reported to be cost effective in the healthcare setting due to reduced complications, fewer hospitalisations, and a reduced length of hospital stay.
An important outcome to enable ONS to be clinically and physiologically effective is compliance (i.e., how much the patient consumes relative to what is prescribed). Whilst good compliance to ONS in both hospital and community patients has been reported (78%), compliance in some patient groups has been reported to be as low as 35%. Poor compliance has been reported due to inability to consume the required volume, poor palatability, and taste fatigue. Furthermore, with increasing trends in plant-based food consumption and veganism, the lack of plant-based ONS may reduce compliance in vegan patients or those wishing to reduce animal-derived consumption for cultural or religious reasons. Consequently, there is a clear need for the development of different types of ONS which better cater both for patients with reported low compliance, but also patients with potentially higher compliance when presented with increased variety and choice.
The aim of this study is to evaluate compliance, acceptability, gastrointestinal tolerance, nutrient intake, appetite, nutritional status, and safety of four new ready to drink ONS. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period. During the intervention period, patients will receive one of the four ONS for 28 days alongside their routine diet.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement (ONS) | Experimental | Dietary Supplement: Dietary supplement (ONS)All patients will receive standardised dietary advice in addition to the ONS prescribed daily for 28 days. The ONS prescription will be determined on an individual basis by the investigating dietitian/nurse responsible for the patient's nutritional management (1-3 ONS per day; aligned with guidelines set out within the Malnutrition Pathway). The ONS prescribed will be the same throughout the 28 days and will be taken orally. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female
- ≥16 years of age
- Identified as being malnourished/at risk of malnutrition by malnutrition screening tools [i.e., MUST score ≥1, and/or using or requiring ONS at least once daily as part of nutritional management plan]
- Expected to receive at least one bottle of ONS per day
- Written or electronic informed consent from patient, or verbally given consent countersigned by a witness for those physically unable to sign
Key exclusion criteria (10 listed)
- Patients receiving parenteral nutrition or ≥70% total energy requirements from enteral tube feeding
- Patients with major hepatic dysfunction (i.e., decompensated liver disease)
- Patients with major renal dysfunction [i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD)]
- Cancer patients likely to anticipate significant gastrointestinal disturbances/taste changes as a result of Systemic Anti-Cancer Therapy (SACT)
- Patients with active/chronic gastrointestinal disease or impaired gastrointestinal function
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 |
|---|---|---|
| Dietary supplement (ONS)At baseline, the investigating dietitian/nurse will record several measures, including clinical history and symptoms over the previous 24 hours. In addition, patients who are already receiving an ONS will continue their prescribed ONS for 1 day in which their gastrointestinal tolerance, ONS compliance and acceptability will be recorded. All patients will then receive standardised dietary advice in addition to one of the four trial ONS products daily for 28 days. The type of ONS will be agreed with the patient and the investigating dietitian/nurse, and the ONS prescription will be determined on an individual basis by the investigating dietitian/nurse responsible for the patient's nutritional management (1-3 ONS per day; aligned with guidelines set out within the Malnutrition Pathway). The type of ONS prescribed will be the same throughout the 28 days and will be taken orally. | Dietary supplement | Dietary supplement (ONS) |
Primary outcome
Compliance with ONS prescription
Time frame: Baseline (Day 1) - End of the study (Day 29)
Compliance with ONS prescription (% of bottle and how many bottles consumed) will be assessed daily by recording how much of the product was prescribed, compared to the amount consumed by the patient. The amount prescribed by the investigating dietitian/nurse will be recorded at the start of the study and any changes to this prescription will also be noted. For patients already receiving an ONS prior to enrolling onto the study, compliance will be assessed for 1 day at baseline. For all patients, compliance with the intervention ONS prescription will be assessed daily throughout the study and will be recorded by the patient/carer. For analysis, the mean daily % and the mean daily number of bottles consumed over the 28 days will be used.
10 secondary outcomes
Nutrient Intake
Time frame: Baseline (Day 1) - End of the study (Day 29)
Acceptability
Time frame: Baseline (Day 1) - End of the study (Day 29)
Gastrointestinal Tolerance
Time frame: Baseline (Day 1) - End of the study (Day 29)
Anthropometry
Time frame: Baseline (Day 1) - End of the study (Day 29)
Nutritional Status
Time frame: Baseline (Day 1) - End of the study (Day 29)
Dietetic Goal
Time frame: Baseline (Day 1) - End of the study (Day 29)
Appetite
Time frame: Baseline (Day 1) - End of the study (Day 29)
Appetite (SNAQ)
Time frame: Baseline (Day 1) - End of the study (Day 29)
Medical and Dietetic History
Time frame: Baseline (Day 1) - End of the study (Day 29)
Adverse Events
Time frame: Baseline (Day 1) - End of the study (Day 29)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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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, PhD study chair
Nutricia Ltd
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement (ONS) in people with Malnutrition, run by Nutricia UK Ltd at 19 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 5 inclusion and 10 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: under way, not looking for participants, 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 19 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?
This study is still under way. Results are not available in the source record yet.
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?
Compliance with ONS prescription (time frame: Baseline (Day 1) - End of the study (Day 29)). 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; AzTrials last refreshed its copy on 7 Nov 2026.