Malnutrition
Conditions
Keywords
Malnutrition, Oral nutritional supplementation, Compliance, Palatability, Older adult
Brief 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 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: 1. What are the compliance rates (% intake) of fortified porridge compared to standard liquid based ONS in malnourished hospitalised older adults? 2. What are the palatability ratings (e.g., taste) of fortified porridge compared to standard liquid based ONS in malnourished hospitalised older adults? 3. 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.
Interventions
DIETARY_SUPPLEMENTStandard liquid-based oral nutritional supplement
An anonymous ready-made drink supplement: 125g, 306kcal, 18.3g protein.
DIETARY_SUPPLEMENTFortified porridge
Vital Daily High Protein Oats (Adams Vital Nutrition Ltd.): 157g, 230kcal, 15g protein.
Sponsors
University Hospital Southampton NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of the Mean Oral Nutritional Supplement Consumed Per Day (%) | 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 | Measured daily during the 4 day testing period | The average amount of daily energy consumed for each nutritional supplement (kcal) |
| Protein Intake (g) | Measured daily during the 4 day testing period | The average daily amount of protein consumed from nutritional supplements (g) |
| Palatability of Oral Nutritional Supplement | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Caloric Intake (kcal) | Completed daily during the 4 day testing period and 2 days before testing (baseline). | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Health Care Professionals Health care professionals working on the wards receiving the intervention, including nurses, dietetics team, and health care assistants. | 5 |
| 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. | 11 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Discharged before study end | 1 | 4 | 0 |
| Overall Study | Feeling too unwell | 1 | 0 | 0 |
| Overall Study | Moved to a different ward | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | New Porridge Supplement, Then Drink-Based Control | Health Care Professionals | Drink-based Control Supplement, Then New Porridge Supplement | Total |
|---|---|---|---|---|
| Age, Continuous | 81.5 years STANDARD_DEVIATION 6.4 | 40.20 years STANDARD_DEVIATION 9.95 | 79.9 years STANDARD_DEVIATION 10.8 | 74.5 years STANDARD_DEVIATION 17.16 |
| Appetite Good appetite, low risk malnutrition | 8 Participants | 0 Participants | 5 Participants | 13 Participants |
| Appetite Poor appetite, high risk malnutrition | 8 Participants | 0 Participants | 6 Participants | 14 Participants |
| Body Mass Index | 24.18 kg/m^2 STANDARD_DEVIATION 5.05 | — | 24 kg/m^2 STANDARD_DEVIATION 4.8 | 24.1 kg/m^2 STANDARD_DEVIATION 5 |
| Care provision Formal provision | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Care provision Informal provision | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Care provision No care | 12 Participants | 0 Participants | 9 Participants | 21 Participants |
| Frailty classification Frail | 12 Participants | 0 Participants | 6 Participants | 18 Participants |
| Frailty classification Not Frail | 4 Participants | 0 Participants | 5 Participants | 9 Participants |
| Marital status Divorced | 3 Participants | 0 Participants | 2 Participants | 5 Participants |
| Marital status Married | 8 Participants | 0 Participants | 5 Participants | 13 Participants |
| Marital status Widowed | 5 Participants | 0 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Any other White background | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized White British | 15 Participants | 3 Participants | 11 Participants | 29 Participants |
| Risk of sarcopenia No sarcopenia | 3 Participants | 0 Participants | 4 Participants | 7 Participants |
| Risk of sarcopenia Sarcopenia | 13 Participants | 0 Participants | 7 Participants | 20 Participants |
| Sex: Female, Male Female | 10 Participants | 5 Participants | 7 Participants | 22 Participants |
| Sex: Female, Male Male | 6 Participants | 0 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 5 | 0 / 27 |
| other Total, other adverse events | 0 / 27 | 0 / 5 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 5 | 0 / 27 |
Outcome results
Primary
Energy (kcal) Consumed
The average amount of daily energy consumed for each nutritional supplement (kcal)
Time frame: Measured daily during the 4 day testing period
Population: Participants with missing data were excluded from analysis. Health professionals completed interviews only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Porridge Supplement | Energy (kcal) Consumed | 141.41 kcal |
| Drink-based Control Supplement | Energy (kcal) Consumed | 450.69 kcal |
p-value: 0.002Wilcoxon (Mann-Whitney)
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).
Time frame: Measured at baseline
Population: Participants with missing data were excluded from analysis. Health professionals completed interviews only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Porridge Supplement | Palatability of Oral Nutritional Supplement | Smell | 4 units on a scale |
| Porridge Supplement | Palatability of Oral Nutritional Supplement | Thickness | 5 units on a scale |
| Porridge Supplement | Palatability of Oral Nutritional Supplement | Sweetness | 4 units on a scale |
| Porridge Supplement | Palatability of Oral Nutritional Supplement | Aftertaste | 4 units on a scale |
| Porridge Supplement | Palatability of Oral Nutritional Supplement | Taste | 4 units on a scale |
| Porridge Supplement | Palatability of Oral Nutritional Supplement | Feeling in mouth | 4 units on a scale |
| Porridge Supplement | Palatability of Oral Nutritional Supplement | Texture | 4 units on a scale |
| Porridge Supplement | Palatability of Oral Nutritional Supplement | Future choice | 4 units on a scale |
| Porridge Supplement | Palatability of Oral Nutritional Supplement | Appearance | 5 units on a scale |
| Drink-based Control Supplement | Palatability of Oral Nutritional Supplement | Future choice | 6 units on a scale |
| Drink-based Control Supplement | Palatability of Oral Nutritional Supplement | Appearance | 6.5 units on a scale |
| Drink-based Control Supplement | Palatability of Oral Nutritional Supplement | Smell | 5.5 units on a scale |
| Drink-based Control Supplement | Palatability of Oral Nutritional Supplement | Taste | 6.5 units on a scale |
| Drink-based Control Supplement | Palatability of Oral Nutritional Supplement | Sweetness | 4.5 units on a scale |
| Drink-based Control Supplement | Palatability of Oral Nutritional Supplement | Texture | 6 units on a scale |
| Drink-based Control Supplement | Palatability of Oral Nutritional Supplement | Thickness | 6 units on a scale |
| Drink-based Control Supplement | Palatability of Oral Nutritional Supplement | Aftertaste | 4 units on a scale |
| Drink-based Control Supplement | Palatability of Oral Nutritional Supplement | Feeling in mouth | 4 units on a scale |
Comparison: Comparing Appearance of supplementsp-value: 0.1Wilcoxon (Mann-Whitney)
Comparison: Comparing Smell of supplements between groupsp-value: 0.1Wilcoxon (Mann-Whitney)
Comparison: Comparing Taste of supplementsp-value: 0.08Wilcoxon (Mann-Whitney)
Comparison: Comparing Sweetness of supplementsp-value: 0.7Wilcoxon (Mann-Whitney)
Comparison: Comparing Texture of supplementsp-value: 0.02Wilcoxon (Mann-Whitney)
Comparison: Comparing Thickness of supplementsp-value: 0.45Wilcoxon (Mann-Whitney)
Comparison: Comparing Aftertaste of supplementsp-value: 0.25Wilcoxon (Mann-Whitney)
Comparison: Comparing 'Feeling in mouth' of supplementsp-value: 0.45Wilcoxon (Mann-Whitney)
Comparison: Comparing 'Future choice' of supplementsp-value: 0.06Wilcoxon (Mann-Whitney)
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).
Time frame: Measured daily during the 4 day testing period
Population: Participants with missing data were excluded from analysis. Health professionals completed interviews only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Porridge Supplement | Percentage of the Mean Oral Nutritional Supplement Consumed Per Day (%) | 26.31 percentage of supplement consumed |
| Drink-based Control Supplement | Percentage of the Mean Oral Nutritional Supplement Consumed Per Day (%) | 66.8 percentage of supplement consumed |
p-value: 0.01Wilcoxon (Mann-Whitney)
Primary
Protein Intake (g)
The average daily amount of protein consumed from nutritional supplements (g)
Time frame: Measured daily during the 4 day testing period
Population: Participants with missing data were excluded from analysis. Health professionals completed interviews only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Porridge Supplement | Protein Intake (g) | 9.09 grams (g) |
| Drink-based Control Supplement | Protein Intake (g) | 26.51 grams (g) |
p-value: 0.003Wilcoxon (Mann-Whitney)
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.
Time frame: Completed daily during the 4 day testing period and 2 days before testing (baseline).
Population: Participants with missing data were excluded from analysis. Health professionals completed interviews only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Porridge Supplement | Total Caloric Intake (kcal) | 790 kcal |
| Drink-based Control Supplement | Total Caloric Intake (kcal) | 703.25 kcal |
| Baseline | Total Caloric Intake (kcal) | 534.25 kcal |
p-value: 0.004Related samples Friedman's Two-Way ANOVA