ACCEPTABILITY STUDY ON KETOGENIC DIET USING CAMBROOKE'S KETOVIE™
Research type
Research Study
Full title
ACCEPTABILITY STUDY ON KETOGENIC DIET SUPPLEMENT USING CAMBROOKE KETOVIE™ MEDICAL FOODS
IRAS ID
228906
Contact name
Victoria Whiteley
Contact email
Sponsor organisation
Cambrooke Therapeutics
Duration of Study in the UK
1 years, 0 months, 8 days
Research summary
The objective of this study is to evaluate the acceptability, G.I. tolerance and palatability of Ketovie™ medical food for patients on ketogenic diet (KD).
Persons with intractable epilepsy and other neurodegenerative disorders, such as glucose transporter type-1 deficiency syndrome (GLUT-1 DS) and pyruvate dehydrogenase deficiency (PDHD), who cannot rely on traditional drugs for their treatment may be treated with dietary therapy. KD is a high fat diet where carbohydrates are almost completely eliminated so that almost no glucose is available for the body to burn as energy. The diet can be difficult to follow and is very restrictive, because even the smallest amounts of carbohydrates will disrupt ketosis. As demonstrated by several studies, the KD therapy is an effective treatment is reducing the number of seizures in patients with intractable epilepsy and neurodegenerative disorders. .
Ketovie is a convenient ready-to-drink, good-tasting, nutritionally complete option for the patient on KD. It has a 4:1 (four parts fat to 1 part combined protein and usable carbohydrates) formulation and it’s fortified with vitamins and minerals. Patients, currently on an oral KD and with one of several disorders: epilepsy, GLUT-1 DS, PDHD, or other disorders where a ketogenic diet is indicated, over 3 years of age, both male and female, will be given a choice of 2 flavors of Ketovie and asked to consume 1 per day for 7 days as a component of their KD therapy. The patient or their caregiver will record the quantity and time each Ketovie beverage is consumed and answer a series of questions regarding the daily experience (taste, smell, texture, ease of use, if any G.I disturbance.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0312
Date of REC Opinion
17 Dec 2018
REC opinion
Further Information Favourable Opinion