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

York Teaching Hospitals NHS Foundation Trust

Status

Terminated

Conditions

Colorectal Surgery

Treatments

Dietary Supplement: Fitabisc

Study type

Interventional

Funder types

Other

Identifiers

NCT03859661

SNE2445

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

16 to 80 years old

Volunteers

No Healthy Volunteers

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.