Ketogenic diet drink study
Research type
Research Study
Full title
Evaluating the tolerance, compliance, acceptability and safety of Ketocal 2.5:1 LQ, a nutritionally complete liquid feed for use as part of the ketogenic diet (KD) in children 8+ years, adolescents and adults with intractable epilepsy or other disorders where the KD is indicated.
IRAS ID
213306
Contact name
Rebecca Stratton
Contact email
Sponsor organisation
Nutricia Ltd
Duration of Study in the UK
2 years, 1 months, 0 days
Research summary
Recently there has been renewed and increased use of the ketogenic diet (KD) in its different forms to manage intractable (drug resistant) epilepsy by neurology centres in older children, adolescents and adults. There are a number of prescribable feeds currently available to be used in the KD either as a sole source of nutrition in children fed via enteral feeding tube, or as a snack or meal replacement in patients fed orally. These have been developed to help with compliance, variety and convenience of the KD and to ensure nutritional needs are met by patients following the KD. However, there are currently no nutritionally complete feeds available for older children, adolescents and adults.
Nutricia has therefore developed Ketocal 2.5:1 LQ which can be used across all the ketogenic diets. It is intended for use in the dietary management of intractable epilepsy and other conditions for which the KD is indicated in children from 8 + years, adolescents and adults. Ketocal 2.5:1 LQ is a liquid formula containing a 2.5:1 ratio of fat to protein and carbohydrate (2.5 g fat for every 1 g protein and carbohydrate). It is a nutritionally complete formula in which medium chain triglycerides (MCT) provide 20% of total energy and can be used as a sole source of nutrition or as a supplementary feed (a snack or meal replacement).
This study will evaluate the gastrointestinal (GI) tolerance, compliance, acceptability and safety of Ketocal 2.5:1 in 40 patients aged 8+ years in the UK. A 3 day baseline period will be followed by a 4 week control period and 4 week intervention period. The study is conducted for tolerance and safety purposes to meet the UK ACBS requirements for acceptability studies. The feed is a Food for Special Medical Purposes and MHRA exempt.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0530
Date of REC Opinion
18 Nov 2016
REC opinion
Further Information Favourable Opinion