A Study to Evaluate the Palatability of a Nutritional Support Biscuit (Fitabisc) (Fitabisc)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Surgery||Dietary Supplement: Fitabisc||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- 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.
- Adherence to dose [ Time Frame: 10 days ]Patients to keep a diary of their consumption
- Palatability of biscuit [ Time Frame: 10 days ]Study will measure palatability on a standard Likert scale after 10 days
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859661
|York Teaching Hospital NHS Foundation Trust|
|York, United Kingdom, YO31 8HE|
|Principal Investigator:||John Macfie, MBChB, MD||York Teaching Hospital NHS Foundation Trust|