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出境医 / 临床实验 / Palatability of Antioxidant Biscuits (Fitabisc2)

Palatability of Antioxidant Biscuits (Fitabisc2)

Study Description
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.


Condition or disease Intervention/treatment Phase
Preoperative Care Antioxidants Dietary Supplement: Fitabisc Not Applicable

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
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
Experimental: Fitabisc
Participants receiving fitabisc preoperatively
Dietary Supplement: Fitabisc
Biscuits containing antioxidants

Outcome Measures
Primary Outcome Measures :
  1. 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?


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between the ages of 16 and 90 years
  • Having planned abdominal surgery at Castle Hill Hospital

Exclusion Criteria:

  • 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
Contacts and Locations

Locations
Layout table for location information
United Kingdom
Castle Hill Hospital
Hull, East Yorkshire, United Kingdom, Hu16 5hl
Sponsors and Collaborators
Hull University Teaching Hospitals NHS Trust
Investigators
Layout table for investigator information
Principal Investigator: John Hartley, MD FRCS Hull and East Yorkshire NHS Trust
Tracking Information
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
 (submitted: July 19, 2019)
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?
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.

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 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
Condition  ICMJE
  • Preoperative Care
  • Antioxidants
Intervention  ICMJE Dietary Supplement: Fitabisc
Biscuits containing antioxidants
Study Arms  ICMJE Experimental: Fitabisc
Participants receiving fitabisc preoperatively
Intervention: Dietary Supplement: Fitabisc
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 19, 2019)
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:

  • Patients between the ages of 16 and 90 years
  • Having planned abdominal surgery at Castle Hill Hospital

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hull University Teaching Hospitals NHS Trust
Study Sponsor  ICMJE Hull University Teaching Hospitals NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Hartley, MD FRCS Hull and East Yorkshire NHS Trust
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