Trial Outcomes & Findings for The RELISH Study: Compliance and Palatability of Oral Nutritional Supplements in Hospitalised Older Adults (NCT NCT05620082)
NCT ID: NCT05620082
Last Updated: 2025-06-12
Results Overview
Compliance to oral nutritional supplementation. Leftovers will be weighed (g) using weighing scales (Seca Model 875 digital weighing scale).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
Measured daily during the 4 day testing period
Results posted on
2025-06-12
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
Health Professionals
Health professionals including nurses, dieticians, dietetic assistants, and health care assistants were interviewed to explore product acceptability
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
11
|
5
|
|
Overall Study
COMPLETED
|
13
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
Health Professionals
Health professionals including nurses, dieticians, dietetic assistants, and health care assistants were interviewed to explore product acceptability
|
|---|---|---|---|
|
Overall Study
Discharged before study end
|
1
|
4
|
0
|
|
Overall Study
Moved to a different ward
|
1
|
0
|
0
|
|
Overall Study
Feeling too unwell
|
1
|
0
|
0
|
Baseline Characteristics
This baseline characteristic was not measured for health professionals participating in interviews
Baseline characteristics by cohort
| Measure |
New Porridge Supplement, Then Drink-Based Control
n=16 Participants
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.
|
Health Care Professionals
n=5 Participants
Health care professionals working on the wards receiving the intervention, including nurses, dietetics team, and health care assistants.
|
Drink-based Control Supplement, Then New Porridge Supplement
n=11 Participants
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.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
81.5 years
STANDARD_DEVIATION 6.4 • n=16 Participants
|
40.20 years
STANDARD_DEVIATION 9.95 • n=5 Participants
|
79.9 years
STANDARD_DEVIATION 10.8 • n=11 Participants
|
74.5 years
STANDARD_DEVIATION 17.16 • n=32 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=16 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=11 Participants
|
22 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=16 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=11 Participants
|
10 Participants
n=32 Participants
|
|
Race/Ethnicity, Customized
White British
|
15 Participants
n=16 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=11 Participants
|
29 Participants
n=32 Participants
|
|
Race/Ethnicity, Customized
Any other White background
|
1 Participants
n=16 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
3 Participants
n=32 Participants
|
|
Marital status
Divorced
|
3 Participants
n=16 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
0 Participants
This baseline characteristic was not measured for health professionals participating in interviews
|
2 Participants
n=11 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
5 Participants
n=27 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
|
Marital status
Married
|
8 Participants
n=16 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
0 Participants
This baseline characteristic was not measured for health professionals participating in interviews
|
5 Participants
n=11 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
13 Participants
n=27 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
|
Marital status
Widowed
|
5 Participants
n=16 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
0 Participants
This baseline characteristic was not measured for health professionals participating in interviews
|
4 Participants
n=11 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
9 Participants
n=27 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
|
Care provision
No care
|
12 Participants
n=16 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
0 Participants
This baseline characteristic was not measured for health professionals participating in interviews
|
9 Participants
n=11 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
21 Participants
n=27 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
|
Care provision
Formal provision
|
2 Participants
n=16 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
0 Participants
This baseline characteristic was not measured for health professionals participating in interviews
|
1 Participants
n=11 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
3 Participants
n=27 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
|
Care provision
Informal provision
|
2 Participants
n=16 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
0 Participants
This baseline characteristic was not measured for health professionals participating in interviews
|
1 Participants
n=11 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
3 Participants
n=27 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
|
Frailty classification
Frail
|
12 Participants
n=16 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
0 Participants
This baseline characteristic was not measured for health professionals participating in interviews
|
6 Participants
n=11 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
18 Participants
n=27 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
|
Frailty classification
Not Frail
|
4 Participants
n=16 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
0 Participants
This baseline characteristic was not measured for health professionals participating in interviews
|
5 Participants
n=11 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
9 Participants
n=27 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
|
Risk of sarcopenia
Sarcopenia
|
13 Participants
n=16 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
0 Participants
This baseline characteristic was not measured for health professionals participating in interviews
|
7 Participants
n=11 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
20 Participants
n=27 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
|
Risk of sarcopenia
No sarcopenia
|
3 Participants
n=16 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
0 Participants
This baseline characteristic was not measured for health professionals participating in interviews
|
4 Participants
n=11 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
7 Participants
n=27 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
|
Appetite
Poor appetite, high risk malnutrition
|
8 Participants
n=16 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
0 Participants
This baseline characteristic was not measured for health professionals participating in interviews
|
6 Participants
n=11 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
14 Participants
n=27 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
|
Appetite
Good appetite, low risk malnutrition
|
8 Participants
n=16 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
0 Participants
This baseline characteristic was not measured for health professionals participating in interviews
|
5 Participants
n=11 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
13 Participants
n=27 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
|
Body Mass Index
|
24.18 kg/m^2
STANDARD_DEVIATION 5.05 • n=16 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
—
|
24 kg/m^2
STANDARD_DEVIATION 4.8 • n=11 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
24.1 kg/m^2
STANDARD_DEVIATION 5 • n=27 Participants • This baseline characteristic was not measured for health professionals participating in interviews
|
PRIMARY outcome
Timeframe: Measured daily during the 4 day testing periodPopulation: Participants with missing data were excluded from analysis. Health professionals completed interviews only.
Compliance to oral nutritional supplementation. Leftovers will be weighed (g) using weighing scales (Seca Model 875 digital weighing scale).
Outcome measures
| Measure |
Porridge Supplement
n=18 Participants
Participants consumed a new porridge supplement twice per day for 2 days.
|
Drink-based Control Supplement
n=18 Participants
Participants consumed standard drink-based supplement twice per day for 2 days
|
Health Professionals
Health professionals including nurses, dieticians, dietetic assistants, and health care assistants were interviewed to explore product acceptability
|
Baseline
The baseline consisted of two days of food diaries analysed before nutritional supplements began
|
|---|---|---|---|---|
|
Percentage of the Mean Oral Nutritional Supplement Consumed Per Day (%)
|
26.31 percentage of supplement consumed
Interval 10.23 to 48.02
|
66.8 percentage of supplement consumed
Interval 26.29 to 75.37
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured daily during the 4 day testing periodPopulation: Participants with missing data were excluded from analysis. Health professionals completed interviews only.
The average amount of daily energy consumed for each nutritional supplement (kcal)
Outcome measures
| Measure |
Porridge Supplement
n=18 Participants
Participants consumed a new porridge supplement twice per day for 2 days.
|
Drink-based Control Supplement
n=18 Participants
Participants consumed standard drink-based supplement twice per day for 2 days
|
Health Professionals
Health professionals including nurses, dieticians, dietetic assistants, and health care assistants were interviewed to explore product acceptability
|
Baseline
The baseline consisted of two days of food diaries analysed before nutritional supplements began
|
|---|---|---|---|---|
|
Energy (kcal) Consumed
|
141.41 kcal
Interval 63.13 to 249.32
|
450.69 kcal
Interval 198.69 to 492.33
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured daily during the 4 day testing periodPopulation: Participants with missing data were excluded from analysis. Health professionals completed interviews only.
The average daily amount of protein consumed from nutritional supplements (g)
Outcome measures
| Measure |
Porridge Supplement
n=18 Participants
Participants consumed a new porridge supplement twice per day for 2 days.
|
Drink-based Control Supplement
n=18 Participants
Participants consumed standard drink-based supplement twice per day for 2 days
|
Health Professionals
Health professionals including nurses, dieticians, dietetic assistants, and health care assistants were interviewed to explore product acceptability
|
Baseline
The baseline consisted of two days of food diaries analysed before nutritional supplements began
|
|---|---|---|---|---|
|
Protein Intake (g)
|
9.09 grams (g)
Interval 4.06 to 16.02
|
26.51 grams (g)
Interval 11.69 to 28.96
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at baselinePopulation: Participants with missing data were excluded from analysis. Health professionals completed interviews only.
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).
Outcome measures
| Measure |
Porridge Supplement
n=24 Participants
Participants consumed a new porridge supplement twice per day for 2 days.
|
Drink-based Control Supplement
n=24 Participants
Participants consumed standard drink-based supplement twice per day for 2 days
|
Health Professionals
Health professionals including nurses, dieticians, dietetic assistants, and health care assistants were interviewed to explore product acceptability
|
Baseline
The baseline consisted of two days of food diaries analysed before nutritional supplements began
|
|---|---|---|---|---|
|
Palatability of Oral Nutritional Supplement
Appearance
|
5 units on a scale
Interval 4.0 to 6.0
|
6.5 units on a scale
Interval 4.0 to 7.0
|
—
|
—
|
|
Palatability of Oral Nutritional Supplement
Smell
|
4 units on a scale
Interval 4.0 to 5.25
|
5.5 units on a scale
Interval 4.0 to 7.0
|
—
|
—
|
|
Palatability of Oral Nutritional Supplement
Taste
|
4 units on a scale
Interval 2.0 to 6.25
|
6.5 units on a scale
Interval 4.25 to 7.0
|
—
|
—
|
|
Palatability of Oral Nutritional Supplement
Sweetness
|
4 units on a scale
Interval 3.0 to 7.0
|
4.5 units on a scale
Interval 2.25 to 7.0
|
—
|
—
|
|
Palatability of Oral Nutritional Supplement
Texture
|
4 units on a scale
Interval 2.0 to 6.0
|
6 units on a scale
Interval 4.0 to 7.0
|
—
|
—
|
|
Palatability of Oral Nutritional Supplement
Thickness
|
5 units on a scale
Interval 2.75 to 7.0
|
6 units on a scale
Interval 4.0 to 7.0
|
—
|
—
|
|
Palatability of Oral Nutritional Supplement
Aftertaste
|
4 units on a scale
Interval 2.75 to 5.0
|
4 units on a scale
Interval 2.25 to 7.0
|
—
|
—
|
|
Palatability of Oral Nutritional Supplement
Feeling in mouth
|
4 units on a scale
Interval 1.5 to 5.0
|
4 units on a scale
Interval 3.0 to 7.0
|
—
|
—
|
|
Palatability of Oral Nutritional Supplement
Future choice
|
4 units on a scale
Interval 1.75 to 6.0
|
6 units on a scale
Interval 4.0 to 7.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Porridge Supplement
n=20 Participants
Participants consumed a new porridge supplement twice per day for 2 days.
|
Drink-based Control Supplement
n=20 Participants
Participants consumed standard drink-based supplement twice per day for 2 days
|
Health Professionals
Health professionals including nurses, dieticians, dietetic assistants, and health care assistants were interviewed to explore product acceptability
|
Baseline
n=20 Participants
The baseline consisted of two days of food diaries analysed before nutritional supplements began
|
|---|---|---|---|---|
|
Total Caloric Intake (kcal)
|
790 kcal
Interval 593.0 to 979.5
|
703.25 kcal
Interval 580.31 to 931.25
|
—
|
534.25 kcal
Interval 410.13 to 804.75
|
Adverse Events
New Porridge Supplement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Care Professionals
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Drink-Based Control Supplement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place