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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Preoperative Care Antioxidants | Dietary Supplement: Fitabisc | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Study to Evaluate the Palatability of a Nutritional Support Biscuit (Fitabisc) in Patients About to Undergo Abdominal Surgery |
Estimated Study Start Date : | January 1, 2018 |
Estimated Primary Completion Date : | September 20, 2018 |
Estimated Study Completion Date : | December 20, 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: Fitabisc
Participants receiving fitabisc preoperatively
|
Dietary Supplement: Fitabisc
Biscuits containing antioxidants
|
Ages Eligible for Study: | 16 Years to 80 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Castle Hill Hospital | |
Hull, East Yorkshire, United Kingdom, Hu16 5hl |
Principal Investigator: | John Hartley, MD FRCS | Hull and East Yorkshire NHS Trust |
Tracking Information | |||||
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First Submitted Date ICMJE | June 26, 2019 | ||||
First Posted Date ICMJE | July 22, 2019 | ||||
Last Update Posted Date | July 22, 2019 | ||||
Estimated Study Start Date ICMJE | January 1, 2018 | ||||
Estimated Primary Completion Date | September 20, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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?
|
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Palatability of Antioxidant Biscuits | ||||
Official Title ICMJE | A Study to Evaluate the Palatability of a Nutritional Support Biscuit (Fitabisc) in Patients About to Undergo Abdominal Surgery | ||||
Brief 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 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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
|
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Intervention ICMJE | Dietary Supplement: Fitabisc
Biscuits containing antioxidants
|
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Study Arms ICMJE | Experimental: Fitabisc
Participants receiving fitabisc preoperatively
Intervention: Dietary Supplement: Fitabisc
|
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Withdrawn | ||||
Actual Enrollment ICMJE |
0 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 20, 2018 | ||||
Estimated Primary Completion Date | September 20, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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Sex/Gender ICMJE |
|
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Ages ICMJE | 16 Years to 80 Years (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04027504 | ||||
Other Study ID Numbers ICMJE | R2206 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Hull University Teaching Hospitals NHS Trust | ||||
Study Sponsor ICMJE | Hull University Teaching Hospitals NHS Trust | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Hull University Teaching Hospitals NHS Trust | ||||
Verification Date | July 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |