Colorectal SurgeryFitabiscNCT03859661
A Study to Evaluate the Palatability of a Nutritional Support Biscuit (Fitabisc)
A study testing Fitabisc in people with Colorectal Surgery, run by York Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A study to evaluate the palatability of a nutritional support biscuit (Fitabisc) in patients about to undergo colorectal surgery. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- Fitabisc
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2015to 11 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients between the ages of 16 and 80 years inclusive.
- Patients who are having colorectal surgery.
- Patients who are able to give voluntary, written informed consent to participate in the study and from whom written consent has been obtained.
Who cannot join
- Those who cannot or do not provide informed consent
- Patients with a known or suspected allergy to any of the ingredients of Fitabisc e.g. gluten or dairy products
- Patients with one of the following co-morbidities:
- Haemochromatosis
- Thalassaemia
- Kidney disease
Show all 10Show fewer
- Liver disease
- Reye syndrome
- Patients who already take supplements of vitamin C, E, selenium or glutamine.
- Patients with type 1 diabetes, or type 2 diabetes that requires them to have insulin or a hypoglycaemic drug such as Metformin.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
York Teaching Hospital NHS Foundation Trust
York, YO31 8HE
About this study
A study to evaluate the palatability of a nutritional support biscuit (Fitabisc) in patients about to undergo colorectal surgery.
Read the detailed description
The question of preoperative supplementation raises another issue about how this might be provided for patients, especially at home.
The Chief Investigator has formulated a new biscuit 'Fitabisc' that contains the key antioxidants; vitamins C and E, selenium and glutamine. The advantage of a biscuit is that all ingredients of interest are combined within the one item and so this may be easier for patients to 'take' than other types of supplement. A survey involving 17 community pharmacies in England and Northern Ireland found that 60% of patients aged 60 - 89 years had difficulty swallowing tablets and capsules. The consistency of the biscuit is softer than traditional shortbread and crumbs readily which we hope will make it easy to eat.
The aim of this study is to test the palatability of Fitabisc and whether patients undergoing abdominal surgery can eat it in the desired quantities for 10 days before they are admitted to hospital.
In summary, most studies to date have looked perioperative or postoperative supplementation with antioxidants alone. No attempt has been made to do this using a palatable biscuit that would facilitate preoperative oral supplementation. If this study confirms the palatability of the biscuit and there is adherence to eating it then it would be our intention to set up a prospective randomized study in which the potential efficacy of Fitabisc would be evaluated.
- Conditions
- Colorectal Surgery
- Being tested
- Fitabisc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitabiscDietary supplement
Fitabisc is a chocolate cookie with vanilla cream filling which contains the most important antioxidants Vitamin C, Vitamin E, and the mineral Selenium. Fitabisc is not commercially available and for the purposes of this study it will be manufactured by Calerrific Ltd, which already produces a biscuit called CalBisc 100 as a simple calorie and nutritional supplement. Production takes place in a BRC Global Standard Grade A certified bakery operated by Farringford Foods in Portadown, Northern Ireland.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to dose
Patients to keep a diary of their consumption
Measured: 10 days
Palatability of biscuit
Study will measure palatability on a standard Likert scale after 10 days
Measured: 10 days
Secondary outcomes (2)
Progress of patients following surgery
Adverse event collection - via patient reported outcomes and review of patient notes following surgery
Measured: 4-6 weeks post op.
Collection of events that might be associated with the ingredients of the biscuit.
Adverse event collection - via patient reported outcomes and review of patient notes following surgery
Measured: 4-6 weeks post op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study startDec 2015
- Primary completion11 Sep 2017
- Study completion11 Sep 2017
Why it stopped: Study was halted due to poor recruitment and date on the biscuits expiring
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- York Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Macfie, MBChB, MD, Principal investigator, York Teaching Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859661
- Sponsor's protocol ID
- SNE2445
- Acronym
- Fitabisc
- Status last verified
- Feb 2019
- First submitted
- 24 Jan 2017
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Palatability of a Nutritional Support Biscuit (Fitabisc)
- ClinicalTrials.gov ID
- NCT03859661
- Acronym / sponsor ID
- Fitabisc / SNE2445
- Conditions
- Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was halted due to poor recruitment and date on the biscuits expiring
- Enrolment
- 10 participants (actual)
- Lead sponsor
- York Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 11 Sep 2017 (actual)
- Study completion
- 11 Sep 2017 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the palatability of a nutritional support biscuit (Fitabisc) in patients about to undergo colorectal surgery.
Detailed description
The question of preoperative supplementation raises another issue about how this might be provided for patients, especially at home.
The Chief Investigator has formulated a new biscuit 'Fitabisc' that contains the key antioxidants; vitamins C and E, selenium and glutamine. The advantage of a biscuit is that all ingredients of interest are combined within the one item and so this may be easier for patients to 'take' than other types of supplement. A survey involving 17 community pharmacies in England and Northern Ireland found that 60% of patients aged 60 - 89 years had difficulty swallowing tablets and capsules. The consistency of the biscuit is softer than traditional shortbread and crumbs readily which we hope will make it easy to eat.
The aim of this study is to test the palatability of Fitabisc and whether patients undergoing abdominal surgery can eat it in the desired quantities for 10 days before they are admitted to hospital.
In summary, most studies to date have looked perioperative or postoperative supplementation with antioxidants alone. No attempt has been made to do this using a palatable biscuit that would facilitate preoperative oral supplementation. If this study confirms the palatability of the biscuit and there is adherence to eating it then it would be our intention to set up a prospective randomized study in which the potential efficacy of Fitabisc would be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between the ages of 16 and 80 years inclusive.
- Patients who are having colorectal surgery.
- Patients who are able to give voluntary, written informed consent to participate in the study and from whom written consent has been obtained.
Key exclusion criteria (10 listed)
- Those who cannot or do not provide informed consent
- Patients with a known or suspected allergy to any of the ingredients of Fitabisc e.g. gluten or dairy products
- Patients with one of the following co-morbidities:
- Patients who already take supplements of vitamin C, E, selenium or glutamine.
- Patients with type 1 diabetes, or type 2 diabetes that requires them to have insulin or a hypoglycaemic drug such as Metformin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitabiscFitabisc is a chocolate cookie with vanilla cream filling which contains the most important antioxidants Vitamin C, Vitamin E, and the mineral Selenium. Fitabisc is not commercially available and for the purposes of this study it will be manufactured by Calerrific Ltd, which already produces a biscuit called CalBisc 100 as a simple calorie and nutritional supplement. Production takes place in a BRC Global Standard Grade A certified bakery operated by Farringford Foods in Portadown, Northern Ireland. | Dietary supplement | – |
Primary outcome
Adherence to dose
Time frame: 10 days
Patients to keep a diary of their consumption
Palatability of biscuit
Time frame: 10 days
Study will measure palatability on a standard Likert scale after 10 days
2 secondary outcomes
Progress of patients following surgery
Time frame: 4-6 weeks post op.
Collection of events that might be associated with the ingredients of the biscuit.
Time frame: 4-6 weeks post op.
Results and safety
The study was stopped early (reason given: Study was halted due to poor recruitment and date on the biscuits expiring). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Macfie, MBChB, MD principal investigator
York Teaching Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitabisc in people with Colorectal Surgery, run by York Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was halted due to poor recruitment and date on the biscuits expiring). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to dose (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.