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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard liquid-based oral nutritional supplement | Dietary Supplement | An anonymous ready-made drink supplement: 125g, 306kcal, 18.3g protein. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 daily during the 4 day testing period |
| Energy (kcal) Consumed | The average amount of daily energy consumed for each nutritional supplement (kcal) | Measured daily during the 4 day testing period |
| Protein Intake (g) | The average daily amount of protein consumed from nutritional supplements (g) | 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 at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Completed daily during the 4 day testing period and 2 days before testing (baseline). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samantha J Meredith, PhD | University of Southampton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Southanmpton NHS Foundation Trust | Southampton | Hampshire | SO16 6YD | United Kingdom |
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114 patients were aproached after screening, 29 consented and 27 were randomised. We aimed to recruit 50 participants to the trial. Recruitment proved very challenging and after extending the study recruitment period, improving our recruitment strategies, and reviewing eligibility criteria, we recruited 27 patients to the trial and 5 staff. This number was deemed appropriate to answer our main research questions.
469 patients were screened for eligibility between April 22, 2024 and December 13, 2024 on medicine for older people wards and orthogeriatric wards in Southampton General Hospital, UK.
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| ID | Title | Description |
|---|---|---|
| FG000 | Porridge Supplement, Then Drink-based Control | Participants first received a new porridge supplement twice per day for 2 days, and then the drink-based control supplement twice per day for 2 days. |
| FG001 | Drink-based Control Supplement, Then Porridge Supplement | Participants first consumed a drink-based control supplement twice per day for 2 days, and then the new porridge supplement twice per day for 2 days. |
| FG002 | Health Professionals | Health professionals including nurses, dieticians, dietetic assistants, and health care assistants were interviewed to explore product acceptability |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | New Porridge Supplement, Then Drink-Based Control | Participants were given a new porridge supplement twice per day for 2 days, in addition to normal meals, in-between breakfast and lunch, and after dinner. Then a drink-based control supplement was given twice per day for 2 days. Standard liquid-based oral nutritional supplement: An anonymous ready-made drink supplement: 125g, 306kcal, 18.3g protein. Fortified porridge: Vital Daily High Protein Oats (Adams Vital Nutrition Ltd.): 157g, 230kcal, 15g protein. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Participants with missing data were excluded from analysis. Health professionals completed interviews only. | Posted | Median | Inter-Quartile Range | percentage of supplement consumed | Measured daily during the 4 day testing period |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | New Porridge Supplement | Participants were given a new porridge supplement twice per day for 2 days, in addition to normal meals, in-between breakfast and lunch, and after dinner (Adams Vital Nutrition Ltd. High Protein Oats, 157g, 230kcal, 15g protein). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Samantha J Meredith | University of Southampton | 0238120 | 4656 | s.j.meredith@soton.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2024 | May 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
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| Fortified porridge | Dietary Supplement | Vital Daily High Protein Oats (Adams Vital Nutrition Ltd.): 157g, 230kcal, 15g protein. |
|
| Feeling too unwell |
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| BG001 | Health Care Professionals | Health care professionals working on the wards receiving the intervention, including nurses, dietetics team, and health care assistants. |
| BG002 | Drink-based Control Supplement, Then New Porridge Supplement | Participants were given a drink-based control supplement twice per day for 2 days, in addition to normal meals, in-between breakfast and lunch, and after dinner. Then a a new porridge supplement was given twice per day for 2 days. Standard liquid-based oral nutritional supplement: An anonymous ready-made drink supplement: 125g, 306kcal, 18.3g protein. Fortified porridge: Vital Daily High Protein Oats (Adams Vital Nutrition Ltd.): 157g, 230kcal, 15g protein. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Marital status | This baseline characteristic was not measured for health professionals participating in interviews | Count of Participants | Participants |
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| Care provision | This baseline characteristic was not measured for health professionals participating in interviews | This baseline characteristic was not measured for health professionals participating in interviews | Count of Participants | Participants |
|
| Frailty classification | The Program of Research to Integrate Services for the Maintenance of Autonomy (PRISMA-7) screening tool was used to characterise participants' frailty status. The questionnaire contains seven items with a positive score of three or more indicating frailty. | This baseline characteristic was not measured for health professionals participating in interviews | Count of Participants | Participants |
|
| Risk of sarcopenia | The Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls (SARC-F) questionnaire was used as a measure to assess for sarcopenia. It comprises five components: strength, assistance in walking, rise from a chair, climbing stairs and falls. The scores range from 0 to 10, with a score of equal to or greater than four being predictive of sarcopenia and poor outcome. | This baseline characteristic was not measured for health professionals participating in interviews | Count of Participants | Participants |
|
| Appetite | Appetite was measured using the Simplified Nutritional Appetite Questionnaire (SNAQ), which has been validated to predict weight loss in community dwelling older adults and used to predict poor health outcomes in hospitalised older people. SNAQ is a four-item tool assessing appetite, satiety, taste of food and number of meals per day. SNAQ has a maximum score of 20, with a score of ≤14 indicating poor appetite. | This baseline characteristic was not measured for health professionals participating in interviews | Count of Participants | Participants |
|
| Body Mass Index | This baseline characteristic was not measured for health professionals participating in interviews | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | Health Professionals | Health professionals including nurses, dieticians, dietetic assistants, and health care assistants were interviewed to explore product acceptability |
|
|
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| Primary | Energy (kcal) Consumed | The average amount of daily energy consumed for each nutritional supplement (kcal) | Participants with missing data were excluded from analysis. Health professionals completed interviews only. | Posted | Median | Inter-Quartile Range | kcal | Measured daily during the 4 day testing period |
|
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| Primary | Protein Intake (g) | The average daily amount of protein consumed from nutritional supplements (g) | Participants with missing data were excluded from analysis. Health professionals completed interviews only. | Posted | Median | Inter-Quartile Range | grams (g) | Measured daily during the 4 day testing period |
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| Primary | 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). | Participants with missing data were excluded from analysis. Health professionals completed interviews only. | Posted | Median | Inter-Quartile Range | units on a scale | Measured at baseline |
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| Secondary | 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. | Participants with missing data were excluded from analysis. Health professionals completed interviews only. | Posted | Median | Inter-Quartile Range | kcal | Completed daily during the 4 day testing period and 2 days before testing (baseline). |
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| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Health Care Professionals | Health care professionals working on the wards receiving the intervention, including nurses, dietetics team, and health care assistants. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Drink-Based Control Supplement | Participants were given a drink-based supplement twice per day for 2 days, in addition to normal meals, in-between breakfast and lunch, and after dinner (125g, 306kcal, 18g protein). | 0 | 27 | 0 | 27 | 0 | 27 |
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| D015438 | Health Behavior |
| D001519 | Behavior |
| Male |
|
| Title | Measurements |
|---|---|
|
| Married |
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| Widowed |
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| Formal provision |
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| Informal provision |
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| Not Frail |
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| No sarcopenia |
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| Good appetite, low risk malnutrition |
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| Taste |
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| Sweetness |
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| Texture |
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| Thickness |
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| Aftertaste |
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| Feeling in mouth |
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| Future choice |
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| 0.10 |
| Superiority |
| Comparing Taste of supplements | Wilcoxon (Mann-Whitney) | 0.08 | Superiority |
| Comparing Sweetness of supplements | Wilcoxon (Mann-Whitney) | 0.70 | Superiority |
| Comparing Texture of supplements | Wilcoxon (Mann-Whitney) | 0.02 | Superiority |
| Comparing Thickness of supplements | Wilcoxon (Mann-Whitney) | 0.45 | Superiority |
| Comparing Aftertaste of supplements | Wilcoxon (Mann-Whitney) | 0.25 | Superiority |
| Comparing 'Feeling in mouth' of supplements | Wilcoxon (Mann-Whitney) | 0.45 | Superiority |
| Comparing 'Future choice' of supplements | Wilcoxon (Mann-Whitney) | 0.06 | Superiority |