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

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

Study Overview

• Status: Terminated
• Conditions: Colorectal Surgery
• Intervention / Treatment: Dietary supplement: Fitabisc

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • York, United Kingdom, YO31 8HE
    • York Teaching Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to dose	Patients to keep a diary of their consumption	10 days
Palatability of biscuit	Study will measure palatability on a standard Likert scale after 10 days	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progress of patients following surgery	Adverse event collection - via patient reported outcomes and review of patient notes following surgery	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	4-6 weeks post op.

Collaborators and Investigators

• Sponsor: York Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: John Macfie, MBChB, MD, York Teaching Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): September 11, 2017
• Study Completion (Actual): September 11, 2017

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SNE2445