MalnutritionNCT05620082
The RELISH Study: Compliance and Palatability of Oral Nutritional Supplements in Hospitalised Older Adults
A study testing Standard liquid-based oral nutritional supplement and Fortified porridge in people with Malnutrition, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The RELISH study will investigate a new oral nutritional supplement (fortified porridge) for older adults in hospital who are undernourished (i.e., have malnutrition). Malnutrition is a lack of nutritional intake that can lead to poor recovery from illness, increasing hospital length of stay, and elevating healthcare… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Standard liquid-based oral nutritional supplement and Fortified porridge
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Apr 2024to 4 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Older adults ≥65 years
- Patients on University Hospital Southampton (UHS) acute medical wards
- Medium-high risk of malnutrition (MUST score 1-4)
- Able to provide written consent
Who cannot join
- Patients that have used ONS in previous month
- Receiving enteral or parental nutrition
- Patients with a MUST score >4 (severely malnourished)
- Patients with a BMI ≤15
- Patients with chronic liver disease, renal failure, dysphagia
- Patients who have had major surgery within the preceding month
Show all 10Show fewer
- Patients with a terminal illness
- Patients receiving end of life care
- Patients unable to eat by mouth (Nil By Mouth [NBM])
- Patients who require alternative ONS as advised by dietetic support
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southanmpton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
About this study
Official title: The RELISH Study: A Prospective Observational Study to Assess Compliance and Palatability of foRtifiEd Porridge Compared to Standard LIquid-baSed Oral Nutritional Supplementation in Hospitalised Older Adults With Malnutrition
The RELISH study will investigate a new oral nutritional supplement (fortified porridge) for older adults in hospital who are undernourished (i.e., have malnutrition). Malnutrition is a lack of nutritional intake that can lead to poor recovery from illness, increasing hospital length of stay, and elevating healthcare costs. 22% of hospitalised older adults are estimated to have malnutrition. Oral nutritional supplementation (ONS) is key in the management of malnutrition. ONS are energy and nutrient dense products designed to increase dietary intake when diet alone is insufficient to meet daily nutritional requirements. However, for the ONS to be effective they need to be palatable (i.e., taste good), so that patients consume them (i.e., have good compliance) to reap the benefits of extra calories and protein. Normally, hospital patients are offered liquid based ONS (sip feeds). However, previous research has pinpointed that 56% of older adults on geriatric wards did not like sip feeds. Hence, exploration of compliance to different ONS formats is an important research direction to maximise malnourished older adult's nutritional intake. Therefore, the current study aimed to investigate the compliance and palatability of novel fortified porridge compared to traditional sip-feeds in malnourished older adults in hospital.
Read the detailed description
22% of hospitalised older adults are estimated to be in a state of malnutrition. Malnutrition, also known as undernutrition, is a lack of nutritional intake leading to decreased fat free mass and diminished physiological functioning. Malnutrition impairs patient recovery, increasing hospital length of stay and escalating healthcare costs. Therefore, the identification and management of malnutrition is a vital patient-centred outcome to enhance older adult's health and quality of life and to enable cost-effective treatment and care.
A key method to support individualised nutritional care of hospital in-patients is the use of oral nutritional supplementation (ONS). ONS are energy and nutrient dense products designed to increase dietary intake when diet alone is insufficient to meet daily nutritional requirements. Overall, research suggests favourable impacts of ONS on nutritional status and healthcare costs, while the impact on functional outcomes and mortality are more controversial. A burgeoning evidence base attests to the importance of considering acceptability and compliance of ONS on adequate intake and thus effectiveness of ONS in practice.
Patient compliance to ONS considers the relationship between the amount of ONS prescribed and the amount of ONS ingested and is important to maximise clinical and cost-effectiveness. Palatability refers to the hedonic (i.e., pleasantness) evaluation of sensory factors, such as taste and smell, leading to alterations in food or fluid consumption. Supplemental preference may be affected by a multitude of factors such as taste, colour, smell, after taste and texture. Typically, hospital patients are offered liquid based ONS (sip feeds). However, previous research has pinpointed that 56% of older adults on geriatric wards did not like sip feeds. Hence, exploration of compliance to different ONS formats is an important research direction to maximise malnourished older adult's nutritional intake.
Malnourished hospitalised older adults should be offered an improved range and provision of ONS to suit patient preferences and maximise intake. For instance, an attractive alternative strategy is the use of energy and protein-dense meals (via fortification) or snacks (supplementation), including fortified bread, protein-enriched main meals and between meal snacks, such as biscuits, yoghurt and ice cream. Yet this is an understudied area, with limited data investigating compliance to alternative ONS products compared to ready-made drinks in hospital, such as powdered ONS and snacks, or their clinical effectiveness. Therefore, the current study aimed to investigate the compliance and palatability of novel fortified porridge compared to traditional sip-feeds in malnourished hospitalised older adults.
Research questions include:
- What are the compliance rates (% intake) of fortified porridge compared to standard liquid based ONS in malnourished hospitalised older adults?
- What are the palatability ratings (e.g., taste) of fortified porridge compared to standard liquid based ONS in malnourished hospitalised older adults?
- What is the acceptability of fortified porridge compared to standard liquid based ONS in malnourished hospitalised older adults, including facilitators and barriers to their use on medical wards?
A mixed methods randomised controlled crossover design will be conducted to determine compliance and palatability of fortified porridge in malnourished hospitalised older adults compared to a liquid-based control ONS. The acceptability of products will be assessed through qualitative interviews to explore patients and healthcare professionals' experiences and views of using the nutritional supplements. Participants will be prescribed ONS twice per day for 4 days, in addition to normal meals, in a crossover design. The products will be offered in-between breakfast and lunch, and after dinner to reduce the detrimental long period of calorie absence experienced overnight.
- Conditions
- Malnutrition
- Being tested
- Standard liquid-based oral nutritional supplement, Fortified porridge
- Keywords
- Malnutrition, Oral nutritional supplementation, Compliance, Palatability, Older adult
- Medical subject headings
- Malnutrition, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard liquid-based oral nutritional supplementDietary supplement
An anonymous ready-made drink supplement: 125g, 306kcal, 18.3g protein.
Fortified porridgeDietary supplement
Vital Daily High Protein Oats (Adams Vital Nutrition Ltd.): 157g, 230kcal, 15g protein.
| Study group | Role | What they receive |
|---|---|---|
| New fortified porridge, then drink-based control | Experimental | Participants will first be given a new fortified porridge (Adams Vital Nutrition Ltd. High Protein Oats, 157g, 230kcal, 15g protein) twice per day for the first 2 days, in addition to normal meals in-between breakfast and lunch, and after dinner. Then given a drink-based control supplement (125g, 306kcal, 18g protein) for the next 2 days. Receives: Dietary Supplement: Standard liquid-based oral nutritional supplement; Dietary Supplement: Fortified porridge |
| Health care professionals | No intervention | Health care professionals working on the wards receiving the intervention, including nurses, dietetics team, and health care assistants were interviewed to explore acceptability of products. |
| Drink-based control, then new fortified porridge | Experimental | Participants will be given an anonymous drink-based control supplement twice per day for the first 2 days, in addition to normal meals, in-between breakfast and lunch, and after dinner. Then given a new fortified porridge supplement (157g, 230kcal, 15g protein) for the next 2 days. Receives: Dietary Supplement: Standard liquid-based oral nutritional supplement; Dietary Supplement: Fortified porridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of the Mean Oral Nutritional Supplement Consumed Per Day (%)
Compliance to oral nutritional supplementation. Leftovers will be weighed (g) using weighing scales (Seca Model 875 digital weighing scale).
Measured: Measured daily during the 4 day testing period
Energy (kcal) Consumed
The average amount of daily energy consumed for each nutritional supplement (kcal)
Measured: Measured daily during the 4 day testing period
Protein Intake (g)
The average daily amount of protein consumed from nutritional supplements (g)
Measured: Measured daily during the 4 day testing period
Palatability of Oral Nutritional Supplement
Palatability ratings, including appearance, smell, taste, sweetness, texture, thickness, aftertaste, mouth feel, and overall likability were assessed with a 7-point hedonic Likert scale (7 = definitely like, 6 = moderately like, 5 = mildly like, 4 = neither like nor dislike, 3 = mildly dislike, 2 = moderately dislike, 1 = definitely dislike).
Measured: Measured at baseline
Secondary outcomes (1)
Total Caloric Intake (kcal)
Total energy intake will be assessed through completion of patient food charts, including estimated proportion of meals consumed. Food charts are a part of patients' standard care and will be completed by the nursing team.
Measured: Completed daily during the 4 day testing period and 2 days before testing (baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start22 Apr 2024
- Primary completion23 Dec 2024
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samantha J Meredith, PhD, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620082
- Sponsor's protocol ID
- RHM MED1921
- Status last verified
- May 2024
- First submitted
- 1 Nov 2022
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RELISH Study: A Prospective Observational Study to Assess Compliance and Palatability of foRtifiEd Porridge Compared to Standard LIquid-baSed Oral Nutritional Supplementation in Hospitalised Older Adults With Malnutrition
- ClinicalTrials.gov ID
- NCT05620082
- Acronym / sponsor ID
- RHM MED1921
- Conditions
- Malnutrition
- Keywords
- Malnutrition, Oral nutritional supplementation, Compliance, Palatability, Older adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Posted 12 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The RELISH study will investigate a new oral nutritional supplement (fortified porridge) for older adults in hospital who are undernourished (i.e., have malnutrition). Malnutrition is a lack of nutritional intake that can lead to poor recovery from illness, increasing hospital length of stay, and elevating healthcare costs. 22% of hospitalised older adults are estimated to have malnutrition. Oral nutritional supplementation (ONS) is key in the management of malnutrition. ONS are energy and nutrient dense products designed to increase dietary intake when diet alone is insufficient to meet daily nutritional requirements. However, for the ONS to be effective they need to be palatable (i.e., taste good), so that patients consume them (i.e., have good compliance) to reap the benefits of extra calories and protein. Normally, hospital patients are offered liquid based ONS (sip feeds). However, previous research has pinpointed that 56% of older adults on geriatric wards did not like sip feeds. Hence, exploration of compliance to different ONS formats is an important research direction to maximise malnourished older adult's nutritional intake. Therefore, the current study aimed to investigate the compliance and palatability of novel fortified porridge compared to traditional sip-feeds in malnourished older adults in hospital.
Detailed description
22% of hospitalised older adults are estimated to be in a state of malnutrition. Malnutrition, also known as undernutrition, is a lack of nutritional intake leading to decreased fat free mass and diminished physiological functioning. Malnutrition impairs patient recovery, increasing hospital length of stay and escalating healthcare costs. Therefore, the identification and management of malnutrition is a vital patient-centred outcome to enhance older adult's health and quality of life and to enable cost-effective treatment and care.
A key method to support individualised nutritional care of hospital in-patients is the use of oral nutritional supplementation (ONS). ONS are energy and nutrient dense products designed to increase dietary intake when diet alone is insufficient to meet daily nutritional requirements. Overall, research suggests favourable impacts of ONS on nutritional status and healthcare costs, while the impact on functional outcomes and mortality are more controversial. A burgeoning evidence base attests to the importance of considering acceptability and compliance of ONS on adequate intake and thus effectiveness of ONS in practice.
Patient compliance to ONS considers the relationship between the amount of ONS prescribed and the amount of ONS ingested and is important to maximise clinical and cost-effectiveness. Palatability refers to the hedonic (i.e., pleasantness) evaluation of sensory factors, such as taste and smell, leading to alterations in food or fluid consumption. Supplemental preference may be affected by a multitude of factors such as taste, colour, smell, after taste and texture. Typically, hospital patients are offered liquid based ONS (sip feeds). However, previous research has pinpointed that 56% of older adults on geriatric wards did not like sip feeds. Hence, exploration of compliance to different ONS formats is an important research direction to maximise malnourished older adult's nutritional intake.
Malnourished hospitalised older adults should be offered an improved range and provision of ONS to suit patient preferences and maximise intake. For instance, an attractive alternative strategy is the use of energy and protein-dense meals (via fortification) or snacks (supplementation), including fortified bread, protein-enriched main meals and between meal snacks, such as biscuits, yoghurt and ice cream. Yet this is an understudied area, with limited data investigating compliance to alternative ONS products compared to ready-made drinks in hospital, such as powdered ONS and snacks, or their clinical effectiveness. Therefore, the current study aimed to investigate the compliance and palatability of novel fortified porridge compared to traditional sip-feeds in malnourished hospitalised older adults.
Research questions include:
- What are the compliance rates (% intake) of fortified porridge compared to standard liquid based ONS in malnourished hospitalised older adults?
- What are the palatability ratings (e.g., taste) of fortified porridge compared to standard liquid based ONS in malnourished hospitalised older adults?
- What is the acceptability of fortified porridge compared to standard liquid based ONS in malnourished hospitalised older adults, including facilitators and barriers to their use on medical wards?
A mixed methods randomised controlled crossover design will be conducted to determine compliance and palatability of fortified porridge in malnourished hospitalised older adults compared to a liquid-based control ONS. The acceptability of products will be assessed through qualitative interviews to explore patients and healthcare professionals' experiences and views of using the nutritional supplements. Participants will be prescribed ONS twice per day for 4 days, in addition to normal meals, in a crossover design. The products will be offered in-between breakfast and lunch, and after dinner to reduce the detrimental long period of calorie absence experienced overnight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| New fortified porridge, then drink-based control | Experimental | Dietary Supplement: Standard liquid-based oral nutritional supplement, Dietary Supplement: Fortified porridgeParticipants will first be given a new fortified porridge (Adams Vital Nutrition Ltd. High Protein Oats, 157g, 230kcal, 15g protein) twice per day for the first 2 days, in addition to normal meals in-between breakfast and lunch, and after dinner. Then given a drink-based control supplement (125g, 306kcal, 18g protein) for the next 2 days. |
| Health care professionals | No intervention | –Health care professionals working on the wards receiving the intervention, including nurses, dietetics team, and health care assistants were interviewed to explore acceptability of products. |
| Drink-based control, then new fortified porridge | Experimental | Dietary Supplement: Standard liquid-based oral nutritional supplement, Dietary Supplement: Fortified porridgeParticipants will be given an anonymous drink-based control supplement twice per day for the first 2 days, in addition to normal meals, in-between breakfast and lunch, and after dinner. Then given a new fortified porridge supplement (157g, 230kcal, 15g protein) for the next 2 days. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Older adults ≥65 years
- Patients on University Hospital Southampton (UHS) acute medical wards
- Medium-high risk of malnutrition (MUST score 1-4)
- Able to provide written consent
Key exclusion criteria (10 listed)
- Patients that have used ONS in previous month
- Receiving enteral or parental nutrition
- Patients with a MUST score >4 (severely malnourished)
- Patients with a BMI ≤15
- Patients with chronic liver disease, renal failure, dysphagia
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 |
|---|---|---|
| Standard liquid-based oral nutritional supplementAn anonymous ready-made drink supplement: 125g, 306kcal, 18.3g protein. | Dietary supplement | Drink-based control, then new fortified porridge, New fortified porridge, then drink-based control |
| Fortified porridgeVital Daily High Protein Oats (Adams Vital Nutrition Ltd.): 157g, 230kcal, 15g protein. | Dietary supplement | Drink-based control, then new fortified porridge, New fortified porridge, then drink-based control |
Primary outcome
Percentage of the Mean Oral Nutritional Supplement Consumed Per Day (%)
Time frame: Measured daily during the 4 day testing period
Compliance to oral nutritional supplementation. Leftovers will be weighed (g) using weighing scales (Seca Model 875 digital weighing scale).
Energy (kcal) Consumed
Time frame: Measured daily during the 4 day testing period
The average amount of daily energy consumed for each nutritional supplement (kcal)
Protein Intake (g)
Time frame: Measured daily during the 4 day testing period
The average daily amount of protein consumed from nutritional supplements (g)
Palatability of Oral Nutritional Supplement
Time frame: Measured at baseline
Palatability ratings, including appearance, smell, taste, sweetness, texture, thickness, aftertaste, mouth feel, and overall likability were assessed with a 7-point hedonic Likert scale (7 = definitely like, 6 = moderately like, 5 = mildly like, 4 = neither like nor dislike, 3 = mildly dislike, 2 = moderately dislike, 1 = definitely dislike).
1 secondary outcome
Total Caloric Intake (kcal)
Time frame: Completed daily during the 4 day testing period and 2 days before testing (baseline).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Samantha J Meredith, PhD principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard liquid-based oral nutritional supplement and Fortified porridge in people with Malnutrition, run by University Hospital Southampton NHS Foundation Trust at 1 site 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 4 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: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of the Mean Oral Nutritional Supplement Consumed Per Day (%) (time frame: Measured daily during the 4 day testing period). The study lists 4 primary outcomes in all. 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 12 Jun 2025.