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A Study to Evaluate the Palatability of a Nutritional Support Biscuit (Fitabisc) (Fitabisc)

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ClinicalTrials.gov Identifier: NCT03859661
Recruitment Status : Terminated (Study was halted due to poor recruitment and date on the biscuits expiring)
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
York Teaching Hospitals NHS Foundation Trust

Brief Summary:
A study to evaluate the palatability of a nutritional support biscuit (Fitabisc) in patients about to undergo colorectal surgery.

Condition or disease Intervention/treatment Phase
Colorectal Surgery Dietary Supplement: Fitabisc Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Study to Evaluate the Palatability of a Nutritional Support Biscuit (Fitabisc)
Study Start Date : December 2015
Actual Primary Completion Date : September 11, 2017
Actual Study Completion Date : September 11, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Dietary Supplement: Fitabisc
    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.


Primary Outcome Measures :
  1. Adherence to dose [ Time Frame: 10 days ]
    Patients to keep a diary of their consumption

  2. Palatability of biscuit [ Time Frame: 10 days ]
    Study will measure palatability on a standard Likert scale after 10 days


Secondary Outcome Measures :
  1. Progress of patients following surgery [ Time Frame: 4-6 weeks post op. ]
    Adverse event collection - via patient reported outcomes and review of patient notes following surgery

  2. Collection of events that might be associated with the ingredients of the biscuit. [ Time Frame: 4-6 weeks post op. ]
    Adverse event collection - via patient reported outcomes and review of patient notes following surgery



Information from the National Library of Medicine

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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 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.

Exclusion Criteria:

  • 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
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859661


Locations
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United Kingdom
York Teaching Hospital NHS Foundation Trust
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
York Teaching Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: John Macfie, MBChB, MD York Teaching Hospital NHS Foundation Trust
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Responsible Party: York Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03859661    
Other Study ID Numbers: SNE2445
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019