Feasibility of a novel nutritional supplement for surgical patients
| ISRCTN | ISRCTN83283595 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83283595 |
| IRAS number | 280595 |
| Secondary identifying numbers | IRAS 280595 |
- Submission date
- 16/05/2023
- Registration date
- 17/05/2023
- Last edited
- 13/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
The feasibility study is designed to identify whether older surgical patients undergoing surgical intervention for abdominal complaints can take a small volume nutritional supplement consisting of essential amino acids with carbohydrate, and whether this supplementation can be sustained over a period of 4 weeks alongside their usual meals without any detrimental impact on appetite.
Who can participate?
Patients over the age of 60 years who are undergoing abdominal surgery either pre-operatively or postoperatively including postoperative elective and emergency patients.
What does the study involve?
The study involves tasting a nutritional supplement and then taking the supplement over a four week period, twice daily. For the preoperative patients we will also assess the impact of the supplement on appetite by measuring appetite using a visual scale whilst eating a breakfast meal.
What are the possible benefits and risks of participating?
This study will help us learn about if these supplements can be tolerated for a period of time and any impacts on a patient you recover from your surgery. This is a safe study, but some parts may feel more difficult to do such as being asked to recall dietary intake relies on memory and may cause frustration and being asked to complete questionnaires may also cause frustration and survey fatigue.
Where is the study run from?
The research is sponsored by The University of Leeds where the researcher is a PhD candidate at The School of Medicine. The testing of participants will be at St. James's University Hospital, Leeds Teaching Hospitals Trust and Carnegie School of Sport, Headingley Campus, Leeds Beckett University.
When is the study starting and how long is it expected to run for?
January 2020 to March 2024
Who is funding the study?
The University of Huddersfield (UK)
Who is the main contact?
Angela Windle, hc16afw@leeds.ac.uk
Dermot Burke, dburke@leeds.ac.uk
Dr Theocharis Ispoglou, t.ispoglou@leedsbeckett.ac.uk
Contact information
Principal Investigator
Lincoln WIng, St James's University Hospital
Beckett Street
Leeds
LS97TF
United Kingdom
| Phone | +44 113 2064498 |
|---|---|
| d.burke@leeds.ac.uk |
Scientific
Leeds Beckett University
Headingley Campus
Leeds
LS6 3QS
United Kingdom
| t.ispoglou@leedsbeckett.ac.uk |
Study information
| Study design | Feasibility study using a crossover design at a single centre |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Efficacy |
| Participant information sheet | 43664 PIS Group 1 v0.2 01Mar2021.pdf |
| Scientific title | Investigating the acceptability and feasibility of a novel nutritional supplement on patients undergoing different treatment stages for cancer and emergency disease presentations |
| Study objectives | The research team aim to investigate the feasibility and acceptability of novel nutritional supplementation in bowel cancer patients preoperatively and patients who have emergency bowel surgery or planned colorectal cancer surgery postoperatively. The project will be conducted in two parts: part A and part B. In part A of the feasibility study the key research question the research team will aim to answer is: “Does consumption of a nutritional gel (65 ml) before an 'ad libitum' breakfast (eat as much as someone can eat) negatively affect appetite and energy intake compared to a breakfast alone (control)?” The key outcomes measured will be nutritional intakes, appetite and palatability perceptions at the breakfast. In part B of the feasibility study the key research question the research team will aim to answer is: “Can participants (who also completed part A) consume two supplements daily over a longer period of time without compromising their ability to eat food?” The key outcomes measured will be habitual nutritional intakes and monitoring compliance to the supplementation regime. A secondary question for participants in part B will be: “Can short-term supplementation improve body composition and aspects of physical fitness?” |
| Ethics approval(s) | Approved 26/03/2021, Yorkshire and the Humber – South Yorkshire Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 207 104 8121; southyorks.rec@hra.nhs.uk), ref:21/YH/0054 |
| Health condition(s) or problem(s) studied | Sarcopenia in older abdominal surgical patients |
| Intervention | Following consent to proceed, all participants undertake a taste test (Part A) where participants record how the supplement tastes to them on a visual analogue scale. The preoperative patients (Group 1) visit Leeds Beckett University campus twice for appetite testing (Part A) where they consume an ad libitum breakfast meal on each occasion, recording their appetite on a visual analogue scale. On one of the two visits the participants will take the supplement alongside. The two visits will then compare effect of supplement on appetite in a crossover design. Postoperative participants (Group 2 & 3) do not undergo appetite testing as they are in hospital. Participants will then be given a 4-week regime of twice daily supplementation (Part B) and record a food diary over 3 days at week 3 to assess impact of supplement on macronutrient intake with supplementation. (see outputs table below for a Flow Diagram illustrating this) Physical assessment is performed on all patients before and after a period of supplementation, measuring handgrip strength using a dynamometer, body composition measurements using a bioelectrical impedance analyser and a timed get up and go test of 3 metres to assess baseline fitness. Overall involvement is for 4-5 weeks. |
| Intervention type | Supplement |
| Primary outcome measure | Part A: 1. Nutritional intake measured using calorie count and macronutrient analysis at each breakfast 2. Appetite assessment (Flint 2000) taken twice at each breakfast meal for the preoperative participants 3. Palatability perceptions measured using visual analogue scales to test palatability of the supplement at single time point Part B, measured using patient interview at a single time point 1. Habitual nutritional intakes 2. Compliance with the supplementation regime |
| Secondary outcome measures | Part B, measured at a single time point: 1. Body composition: Fat mass and muscle mass as measured by a Tanita bioelectrical impedance analyser 2. Jagar dynamometer to measure grip strength 3. Timed get and go test of 3 metres to assess baseline fitness |
| Overall study start date | 29/01/2020 |
| Completion date | 31/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 60 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 18 |
| Total final enrolment | 22 |
| Key inclusion criteria | Group 1 1.1. Patient has colorectal cancer and is due for elective surgery for cancer 1.2. Patient is over 60 years of age Group 2 2.1. Patient has colorectal cancer and had had elective surgery for cancer 2.2. Patient is over 60 years of age Group 3 3.1. Patient has been admitted as an emergency and has had emergency surgical intervention for abdominal conditions.Patient is over 60 years of age. All groups 4. Patient has capacity to understand the study and give informed consent 5. Patient is capable of ingesting the oral supplement |
| Key exclusion criteria | 1. Patient is incapable of understanding the study and giving informed consent 2. Patient is incapable of ingesting the oral supplement 3. Patients with the very rare potential complication of an allergy to nutritional supplement (sodium benzoate or sodium metabisulphites). 4. Preoperative patients (group 1) with pacemakers or similar electrical implants will be excluded as they will undergo bioelectrical impedance studies and this is a contraindication to using the analyser. |
| Date of first enrolment | 06/08/2021 |
| Date of final enrolment | 31/03/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Beckett Street
Leeds
LS9 7TF
United Kingdom
Leeds
LS1 3HE
United Kingdom
Sponsor information
University/education
Faculty Research Office
Room 9.29, Level 9
Leeds
LS2 9NL
England
United Kingdom
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | It is anticipated that the findings will be disseminated through conference presentations and high-impact journal publication |
| IPD sharing plan | The data sharing plans for the study are currently unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | Flow Diagram for Interventions | 17/05/2023 | No | No | |
| Participant information sheet | Group 1 version 0.2 |
01/03/2021 | 17/05/2023 | No | Yes |
| Participant information sheet | Groups 2 & 3 version 0.3 |
01/04/2021 | 17/05/2023 | No | Yes |
| HRA research summary | 28/06/2023 | No | No | ||
| Other files | 24/10/2024 | No | No | ||
| Basic results | 13/08/2025 | No | No | ||
| Protocol file | version 0.1 | 30/11/2020 | 13/08/2025 | No | No |
| Statistical Analysis Plan | 13/08/2025 | No | No |
Additional files
- 43664 PIS postoperative groups 2&3 v0.3 01Apr2021.pdf
- Groups 2 & 3
- 43664 PIS Group 1 v0.2 01Mar2021.pdf
- Group 1
- ISRCTN83283595 Flow Diagram for Interventions.pdf
- Flow Diagram for Interventions
- ISRCTN83283595_Unpublished Patient Flow Diagram.pdf
- ISRCTN83283595 Statistical Analysis Plan.pdf
- ISRCTN83283595 Protocol v0.1 30Nov2020.pdf
- ISRCTN83283595 Basic Results.pdf
Editorial Notes
13/08/2025: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The statistical analysis plan was uploaded as an additional file.
3. The basic results have been uploaded as an additional file.
11/04/2025: The intention to publish date was changed from 01/03/2024 to 01/07/2025. Total final enrolment added.
24/10/2024: Patient flow diagram added.
10/11/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 29/09/2023 to 31/03/2024.
2. The overall end date was changed from 29/09/2023 to 31/03/2024.
3. The plain English summary was updated to reflect these changes.
03/08/2023: The following changes have been made:
1. The recruitment end date has been changed from 01/06/2023 to 29/09/2023.
2. The overall study end date has been changed from 01/06/2023 to 29/09/2023 and the plain English summary updated accordingly.
20/06/2023: Internal review.
17/05/2023: Trial's existence confirmed by NHS HRA.
