Krio
Research type
Research Study
Full title
A feasibility study to evaluate the acceptability of Krio, a food for special medical purposes (FSMP) for use in the ketogenic diet (KD) with regard to product tolerance, compliance and acceptability.
IRAS ID
224142
Contact name
Rachel Meskell
Contact email
Sponsor organisation
Vitaflo (International) Ltd
Duration of Study in the UK
0 years, 1 months, 13 days
Research summary
There are currently four recognised versions of the ketogenic diet (KD) in clinical use. Depending on which type is followed, sufficient fat has to be consumed daily to provide 65-90% of energy requirements, with 6-30% provided by protein but only 4-17% as carbohydrate. The normal Western diet comprises 30-40% of dietary energy as fat, 40-50% as carbohydrate and the remainder from protein.
The KD is demanding and requires a high degree of motivation by patients (and their parents/guardians) to undertake and maintain. The lack of variety in food choice, flavour, taste and texture can lead to fatigue and boredom, potentially affecting the success of the KD.
This prospective, observational study is to evaluate via daily questionnaires the acceptability, tolerance and compliance of Krio, a Food for Special Medical Purposes in a group of participants aged three years and over in the dietary management of conditions requiring a KD, for example, intractable epilepsy and Glut-1 DS. Participants will take Krio orally for seven consecutive days. Evaluation will also be undertaken of satisfaction with and appropriateness of Krio as a product within a KD by participants and/or parents/guardians.
Krio has been developed by Vitaflo to fit the requirements of a KD whilst allowing patients to have a pleasurable, permissible confectionery treat, potentially enhancing well-being and increasing dietary compliance. It enables fat (20g per 28g bar) to be delivered in a palatable and alternative form to the usual sources of dietary fat in the KD such as butter, margarine, oils, cream and proprietary fat emulsions. Krio is solid and has 'bite'. Therefore, it offers a texture and oral experience that is often missed by patients on the KD which has a mainly soft, liquid and creamy consistency.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0317
Date of REC Opinion
3 Jul 2017
REC opinion
Further Information Favourable Opinion