Acceptability Study on Ketogenic Diet using Cambrooke Ketovie Peptide
Research type
Research Study
Full title
Acceptability Study on Ketogenic Diet using Cambrooke Ketovie Peptide
IRAS ID
278353
Contact name
Rachel Meskell
Contact email
Sponsor organisation
Cambrooke Therapeutics
Duration of Study in the UK
0 years, 2 months, 28 days
Research summary
The objective of this study is to evaluate the acceptability, G.I. tolerance and palatability of Ketovie Peptide™ 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 Peptide is a convenient ready-to-use, nutritionally complete option for the patient on KD. It has a 4:1 (four parts fat to 1 part combined protein whey protein enzymatically broken into smaller peptide lengths and then filtered to remove any unbroken particles and usable carbohydrates) formulation and is fortified with vitamins and minerals. Patients, currently enterally fed a 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 asked to consume 1 x 250ml carton per day for 14 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 (smell, texture, ease of use, if any G.I disturbance.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
20/YH/0100
Date of REC Opinion
20 Mar 2020
REC opinion
Unfavourable Opinion