Preoperative CareFitabisc2NCT04027504
Palatability of Antioxidant Biscuits
A study testing Fitabisc in people with Preoperative Care and Antioxidants, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Patients who are due to have planned bowel surgery will be invited to take part in the study. Those that consent, will be given a 5 day supply of 'Fitabisc' (a biscuit designed to have the potential to provide nutritional support).Participants will be asked to eat 4 biscuits a day for a minimum of 5 days prior to… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Preoperative Care, Antioxidants
- What is being tested?
- Fitabisc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2018to 20 Dec 2018
- 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 90 years
- Having planned abdominal surgery at Castle Hill Hospital
Who cannot join
- People who do not give informed consent
- People with a known or suspected allergy to gluten and / or dairy products
- People already taking any of the following as dietary supplements: vitamins C, E, selenium or glutamine
- People with haemochromatosis, thalassaemia, kidney disease, liver disease or Reye syndrome
- People with type 1 diabetes or people with type 2 diabetes who take insulin or hypoglycaemic drugs such as Metformin
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Castle Hill Hospital
Hull, East Yorkshire, Hu16 5hl
About this study
Official title: A Study to Evaluate the Palatability of a Nutritional Support Biscuit (Fitabisc) in Patients About to Undergo Abdominal Surgery
Patients who are due to have planned bowel surgery will be invited to take part in the study. Those that consent, will be given a 5 day supply of 'Fitabisc' (a biscuit designed to have the potential to provide nutritional support).Participants will be asked to eat 4 biscuits a day for a minimum of 5 days prior to their surgery before they are admitted to hospital. They will be asked to complete questionnaires to record the palatability of the biscuit, how much of the daily amount they were able to eat and if they could not eat the full amount, the reason for this.
Information will also be collected on patient's demographic and clinical details.
We will follow participants' progress after surgery so we can be alerted to any possible medium to longer term adverse effects of eating the biscuit, though none are expected.
Read the detailed description
Nutrition and diet have been shown to have a direct impact on the health of the population and of selected patient groups. These beneficial effects have been attributed to the reduction of oxidative damage caused by the normal or excessive free radical production.
Antioxidants (AOX) are substances which inhibit or delay oxidation. The most important source of AOX is dietary intake. The trace elements copper, selenium, manganese, and zinc are all essential components of endogenous AOX defences. Nutritional antioxidants act through different mechanisms but are mainly free radical scavengers.
Oxidative stress occurs when there is an imbalance between generation of reactive oxygen species and inadequate antioxidant defence systems. Oxidative stress can cause cell damage either directly or through altering signalling pathways. Oxidative stress is a unifying mechanism of injury in many types of disease processes, including gastrointestinal diseases. Not surprisingly, many studies have investigated the potential clinical benefits of administering AOX to various patient groups. These results indicate that AOX nutrients do have a role in the intracellular prevention of AOX related damage and of proximity damage propagation. AOX, in particular appear effective in reducing damage which occurs as a result of ischaemia reperfusion injury.
The evidence suggests that the timing of AOX supplementation is important. It is unlikely that AOX will be able to reverse pathological change but they may limit its extension. In acute conditions the concept of a therapeutic window is essential. There appears to be an optimal early timing during which supplementation may have a "preventative" effect. The magnitude of this is probably determined by premorbid state. It is interesting to speculate, therefore, that pre loading with AOX might mitigate against severity of oxidative damage following a defined injury including surgery. There are theoretical reasons to consider that preoperative antioxidant therapy may be beneficial however there are no data available to date that confirms benefits in clinical practice and in particular as a preoperative supplement. Most studies to date have looked perioperative or postoperative supplementation with the antioxidants alone. No attempt has been made to do this using a palatable biscuit that would facilitate preoperative oral supplementation.
The rationale for this study is to establish whether or not Fitabisc, a biscuit that contains key antioxidants can be tolerated for up to 5 days before surgery in patients undergoing abdominal operations.
If this study confirms palatability and adherence to eating the biscuit then it would be our aim to set up a prospective randomised study in which the potential efficacy of Fitabisc would be evaluated.
- Conditions
- Preoperative Care, Antioxidants
- Being tested
- Fitabisc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitabiscDietary supplement
Biscuits containing antioxidants
| Study group | Role | What they receive |
|---|---|---|
| Fitabisc | Experimental | Participants receiving fitabisc preoperatively Receives: Dietary Supplement: Fitabisc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palatibility Test
Do patients about to undergo colorectal surgery find Fitabisc sufficiently palatable that they can eat the biscuit in the required quantities for 10 days prior to their surgery?
Measured: 10 days prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start1 Jan 2018 (estimated)
- Primary completion20 Sep 2018 (estimated)
- Study completion20 Dec 2018 (estimated)
Why it stopped: The biscuits contain higher than the UK recommended daily dose of vitamins C and E, and selenium.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative CareStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- John Hartley, MD FRCS, Principal investigator, Hull and East Yorkshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027504
- Sponsor's protocol ID
- R2206
- Acronym
- Fitabisc2
- Status last verified
- Jul 2019
- First submitted
- 26 Jun 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 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) in Patients About to Undergo Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04027504
- Acronym / sponsor ID
- Fitabisc2 / R2206
- Conditions
- Preoperative Care, Antioxidants
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The biscuits contain higher than the UK recommended daily dose of vitamins C and E, and selenium.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 20 Sep 2018 (estimated)
- Study completion
- 20 Dec 2018 (estimated)
- First posted
- 22 Jul 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.
Patients who are due to have planned bowel surgery will be invited to take part in the study. Those that consent, will be given a 5 day supply of 'Fitabisc' (a biscuit designed to have the potential to provide nutritional support).Participants will be asked to eat 4 biscuits a day for a minimum of 5 days prior to their surgery before they are admitted to hospital. They will be asked to complete questionnaires to record the palatability of the biscuit, how much of the daily amount they were able to eat and if they could not eat the full amount, the reason for this.
Information will also be collected on patient's demographic and clinical details.
We will follow participants' progress after surgery so we can be alerted to any possible medium to longer term adverse effects of eating the biscuit, though none are expected.
Detailed description
Nutrition and diet have been shown to have a direct impact on the health of the population and of selected patient groups. These beneficial effects have been attributed to the reduction of oxidative damage caused by the normal or excessive free radical production.
Antioxidants (AOX) are substances which inhibit or delay oxidation. The most important source of AOX is dietary intake. The trace elements copper, selenium, manganese, and zinc are all essential components of endogenous AOX defences. Nutritional antioxidants act through different mechanisms but are mainly free radical scavengers.
Oxidative stress occurs when there is an imbalance between generation of reactive oxygen species and inadequate antioxidant defence systems. Oxidative stress can cause cell damage either directly or through altering signalling pathways. Oxidative stress is a unifying mechanism of injury in many types of disease processes, including gastrointestinal diseases. Not surprisingly, many studies have investigated the potential clinical benefits of administering AOX to various patient groups. These results indicate that AOX nutrients do have a role in the intracellular prevention of AOX related damage and of proximity damage propagation. AOX, in particular appear effective in reducing damage which occurs as a result of ischaemia reperfusion injury.
The evidence suggests that the timing of AOX supplementation is important. It is unlikely that AOX will be able to reverse pathological change but they may limit its extension. In acute conditions the concept of a therapeutic window is essential. There appears to be an optimal early timing during which supplementation may have a "preventative" effect. The magnitude of this is probably determined by premorbid state. It is interesting to speculate, therefore, that pre loading with AOX might mitigate against severity of oxidative damage following a defined injury including surgery. There are theoretical reasons to consider that preoperative antioxidant therapy may be beneficial however there are no data available to date that confirms benefits in clinical practice and in particular as a preoperative supplement. Most studies to date have looked perioperative or postoperative supplementation with the antioxidants alone. No attempt has been made to do this using a palatable biscuit that would facilitate preoperative oral supplementation.
The rationale for this study is to establish whether or not Fitabisc, a biscuit that contains key antioxidants can be tolerated for up to 5 days before surgery in patients undergoing abdominal operations.
If this study confirms palatability and adherence to eating the biscuit then it would be our aim to set up a prospective randomised study in which the potential efficacy of Fitabisc would be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fitabisc | Experimental | Dietary Supplement: FitabiscParticipants receiving fitabisc preoperatively |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between the ages of 16 and 90 years
- Having planned abdominal surgery at Castle Hill Hospital
Key exclusion criteria (5 listed)
- People who do not give informed consent
- People with a known or suspected allergy to gluten and / or dairy products
- People already taking any of the following as dietary supplements: vitamins C, E, selenium or glutamine
- People with haemochromatosis, thalassaemia, kidney disease, liver disease or Reye syndrome
- People with type 1 diabetes or people with type 2 diabetes who take insulin or hypoglycaemic drugs 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 |
|---|---|---|
| FitabiscBiscuits containing antioxidants | Dietary supplement | Fitabisc |
Primary outcome
Palatibility Test
Time frame: 10 days prior to surgery
Do patients about to undergo colorectal surgery find Fitabisc sufficiently palatable that they can eat the biscuit in the required quantities for 10 days prior to their surgery?
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Individual participant dataSharing planned: No
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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 Hartley, MD FRCS principal investigator
Hull and East Yorkshire NHS 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 Preoperative Care and Antioxidants, run by Hull University Teaching Hospitals NHS 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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 22 Jul 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 withdrawn before enrolling participants, so there are no results.
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?
Palatibility Test (time frame: 10 days prior to surgery). 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 22 Jul 2019.