A Study to Evaluate the Palatability of a Nutritional Support Biscuit (Fitabisc)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Palatability of biscuit
研究概览
简要总结
A study to evaluate the palatability of a nutritional support biscuit (Fitabisc) in patients about to undergo colorectal surgery.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Palatability of biscuit
时间窗: 10 days
Study will measure palatability on a standard Likert scale after 10 days
Adherence to dose
时间窗: 10 days
Patients to keep a diary of their consumption
次要结局
- 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.)