Study Stopped
Study was halted due to poor recruitment and date on the biscuits expiring
A Study to Evaluate the Palatability of a Nutritional Support Biscuit (Fitabisc)
Fitabisc
1 other identifier
interventional
10
1 country
1
Brief Summary
A study to evaluate the palatability of a nutritional support biscuit (Fitabisc) in patients about to undergo colorectal surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2017
CompletedFirst Posted
Study publicly available on registry
March 1, 2019
CompletedMarch 1, 2019
February 1, 2019
1.8 years
January 24, 2017
February 27, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Progress of patients following surgery
4-6 weeks post op.
Collection of events that might be associated with the ingredients of the biscuit.
4-6 weeks post op.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
York Teaching Hospital NHS Foundation Trust
York, YO31 8HE, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
John Macfie, MBChB, MD
York Teaching Hospital NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2017
First Posted
March 1, 2019
Study Start
December 1, 2015
Primary Completion
September 11, 2017
Study Completion
September 11, 2017
Last Updated
March 1, 2019
Record last verified: 2019-02