NCT03859661

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: York Teaching Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Colorectal Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-09-11
• Completion: 2017-09-11
• First posted: 2019-03-01
• Last updated: 2019-03-01

Locations

1 site across 1 country: United Kingdom