Clinical trial NCT03859661: A Study to Evaluate the Palatability of a Nutritional Support Biscuit (Fitabisc)
Official title: A Study to Evaluate the Palatability of a Nutritional Support Biscuit (Fitabisc)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Surgery
Lead sponsor: York Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to dose
timeFrame: 10 days
measure: Palatability of biscuit
timeFrame: 10 days
Secondary outcomes:
measure: Progress of patients following surgery
timeFrame: 4-6 weeks post op.
measure: Collection of events that might be associated with the ingredients of the biscuit.
timeFrame: 4-6 weeks post op.
Other outcomes:
Locations:
city: York
country: United Kingdom
facility: York Teaching Hospital NHS Foundation Trust
Study officials:
affiliation: York Teaching Hospital NHS Foundation Trust
name: John Macfie, MBChB, MD
role: PRINCIPAL_INVESTIGATOR
References: