SuperStarch Study

ISRCTN	ISRCTN45230380
DOI	https://doi.org/10.1186/ISRCTN45230380
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	East Lancashire Healthcare Trust
Funder	East Lancashire Healthcare Trust (UK)

Submission date: 16/04/2015
Registration date: 18/06/2015
Last edited: 13/02/2023

Recruitment status: No longer recruiting
Overall study status: Stopped
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Having a surgical operation can be very stressful for the body. It lowers a patient’s immune system and disrupts their metabolism for a number of weeks or even months after surgery. These factors can increase the likelihood of complications following surgery, such as getting an infection or developing insulin resistance. Insulin resistance, which occurs in type 2 diabetes, is when the body doesn’t produce enough insulin to function properly, or the body’s cells stop reacting to insulin. The development of insulin resistance after surgery is very common, and is linked to an increase in disease and death. It has been shown that having a sugar-based carbohydrate drink before surgery can prevent the development of insulin resistance. As a result, patients are usually given a carbohydrate drink to have the night before surgery, and on the morning of surgery, as part of the Enhanced Recovery Programme (ERP) used in many hospitals. The aim of this study is to test an alternative starch drink called Generation UCAN, which does not contain sugar. Generation UCAN is popular as an exercise and sports drink. In this study, patients having bowel surgery are given either Generation UCAN or the standard sugar-based drink PreLoad® before their operation. The research team will then see if there is a difference in insulin resistance and stress response to surgery in patients who drank either PreLoad® or Generation UCAN before their operation.

Who can participate?
Adults having a laparoscopic bowel resection operation.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (control group) are given the standard pre-operative carbohydrate drink Preload®. Those in group 2 (intervention group) are given the new pre-operative starch drink Generation UCAN. All participants receive the same care according to the standard ERP. Blood samples are taken before and after surgery along with routine medical assessments and questionnaires. Follow up continues until 7 days after surgery.

What are the possible benefits and risks of participating?
The only change to patient care in this study will be the exchange of the standard pre-operative carbohydrate drink for a new one in the treatment group. All other aspects of the patient’s care will remain the same.

Where is the study run from?
East Lancashire Healthcare Trust (UK)

When is the study starting and how long is it expected to run for?
August 2015 to September 2023

Who is funding the study?
East Lancashire Healthcare Trust (UK)

Who is the main contact?
Dr A Krige, anton.krige@elht.nhs.uk

Contact information

Dr Anton Krige
Public

Royal Blackburn Hospital
Haslingden Road
Blackburn
Lancashire
Blackburn
BB2 3HH
United Kingdom

Email	anton.krige@elht.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled unblinded parallel study
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	Effect of a modified starch compared to standard maltodextrin on post-operative insulin resistance when given pre-operatively for laparoscopic colorectal surgery as part of an enhanced recovery program: a pilot RCT (SuperStarch Study)
Study objectives	1. Does the use of a modified, long-acting starch before surgery, the first dose taken the night before and the second up to 2 hours before surgery, reduce the development of insulin resistance post-operatively when given as part of an Enhanced Recovery Protocol? 1.1. Primary null hypothesis: There is no difference in postoperative insulin resistance between patients who drink Preload® compared to those drinking Generation UCAN pre-operatively. 1.2. Primary alternative hypothesis: There is a difference in postoperative insulin resistance between patients who drink Preload® compared to those drinking Generation UCAN pre-operatively. 2. Does the use of a modified, long-acting starch before surgery, the first dose taken the night before and the second up to 2 hours before surgery, attenuate the post-operative stress response and show an improved recovery profile (i.e. reduced incidence of post-operative nausea and vomiting, decreased fatigue and decreased thirst and hunger?) when given as part of an Enhanced Recovery Protocol? 2.1. Secondary null hypotheses: There is no difference in postoperative stress response or in recovery profile between patients who drink Preload® compared to those drinking Generation UCAN pre-operatively. 2.2. Secondary alternative hypotheses: There is a difference in postoperative stress response or in recovery profile between patients who drink Preload® compared to those drinking Generation UCAN pre-operatively.
Ethics approval(s)	North West Centre of Research Ethics Committees, 26/06/2015, ref: 15/NW/0511
Health condition(s) or problem(s) studied	Post-operative insulin resistance
Intervention	Participants are allocated to one of two groups: 1. Group one (control) receives the current pre-operative carbohydrate solution, Preload® (a maltodextrin solution). The Preload® group will follow the standard enhanced recovery protocol (ERP) and ingest two 50g sachets in 800ml water the evening before surgery (providing 95g of carbohydrate) and one sachet (providing 47.5g of carbohydrate) in 400ml water up to 2 hours before surgery. All other aspects of patient care will be standardised as per our ERP. 2. Group two (intervention) receives Generation UCAN (a hydrothermally modified starch solution). This group will ingest 800ml water the night before surgery and 56.55g of flavoured Generation UCAN (providing 47.5g of carbohydrate) in 400ml water up to 2 hours before surgery. All other aspects of patient care will be standardised as per our ERP.
Intervention type	Supplement
Primary outcome measure(s)	Change in insulin resistance from baseline on postoperative day 1 (POD 1) measured by Homeostasis Model Assessment (HOMA), which utilises serial fasting blood glucose and insulin measurements.
Key secondary outcome measure(s)	1. Change in insulin resistance from baseline on POD 2 and POD 3 measured using HOMA 2. Stress response following surgery, measured by sampling cortisol levels preoperatively, at the end of surgery, and at 24 hours post-operatively and the inflammatory response measured by CRP levels pre-operatively, and on POD 1,2 and 3. 3. Ultrasound measurement of gastric volume pre-operatively 4. Recovery profile including: 4.1. PQRS score measured pre-operatively, at 2 hours after surgery, POD 3 and POD 7. 4.2. Muscle strength measured using a grip strength dynamometer pre-operatively, twice daily (morning and afternoon) on POD 1, 2 and 3, and then once daily on alternate days thereafter until discharge (the patient’s dominant hand will be used for this measurement, and the best out of three consecutive strengths will be used with mean values analysed). 4.3. Time to surgical fitness for discharge measured in hours (date and time of fitness for surgical discharge is recorded in the ERP database). Morbidity measured using the POMS score on POD 2 and 5. 4.4. PONV VAS score on POD 1. 5. Sensations of thirst & hunger Visual Analogue Scale (VAS) score immediately pre-operatively and on POD 1. 6. Adverse events i.e. aspiration and hypo- or hyperglycaemia (these are the only relevant safety assessments for these interventions) will be assessed on the operative day for the former & up to the end of POD 1 for the latter. 7. Cost analysis: difference in cost between doses of Pre-Load & Generation UCAN and costs of respective hospital and critical care lengths of stay.
Completion date	01/09/2023
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Patients >18 years 2. Laparoscopic colorectal resection 3. Included in Enhanced Recovery Protocol 4. American Society of Anesthesiologists (ASA) Physical Status classification 1-3 5. Able to give consent
Key exclusion criteria	1. Non-English speaker 2. Pregnancy 3. Diagnosed diabetes mellitus (diet, drug or insulin controlled). 4. Diagnosed impaired glucose tolerance (fasting glucose in POAC >5.5 mmol/l and/or HbA1C>5.7%) 5. Decreased gastrointestinal motility (from medication or disease) or predisposition to reflux 6. Diagnosis of inflammatory bowel disease 7. Allergy to either preoperative carbohydrate drink
Date of first enrolment	01/08/2022
Date of final enrolment	01/02/2023

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Royal Blackburn Hospital

Haslingden Road
Blackburn
BB2 3HH
United Kingdom

Royal Surrey County Hospital

Egerton Road
Guildford
GU2 7XX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
IPD sharing plan	The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file		17/04/2015	23/08/2022	No	No

Additional files

30606 SuperStarch Protocol Version 1.0 17Apr2015.pdf: Protocol file

Editorial Notes

13/02/2023: Study stopped.
23/08/2022: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The recruitment start date was changed from 31/07/2023 to 01/02/2023.
04/01/2022: The public contact's email address has been made visible and the plain English summary updated accordingly.
30/12/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/11/2016 to 01/08/2022.
2. The recruitment end date has been changed from 31/12/2021 to 31/07/2023.
3. The overall trial end date has been changed from 31/01/2022 to 01/09/2023 and the plain English summary updated accordingly.
4. The intention to publish date has been changed from 30/06/2022 to 31/12/2023.
27/08/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/11/2017 to 31/12/2021.
2. The overall trial end date was changed from 31/12/2017 to 31/01/2022.
3. The intention to publish date was changed from 01/06/2018 to 30/06/2022.
10/01/2017: Overall trial start date changed from 01/08/2014 to 01/08/2015. Ethics information completed. Recruitment was initially scheduled for February 2016 and actually started in November 2016.
15/12/2016: Trial end date changed from December 2015 to December 2017.
09/02/2016: Amended recruitment start and end dates and intention to publish date