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
283471
Contact name
Rachel Meskell
Contact email
Sponsor organisation
Cambrooke Therapeutics
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
The objective of this study is to evaluate the acceptability and G.I. tolerance of Ketovie Peptide™ for children on ketogenic diet (KD). Children with uncontrolled (intractable) epilepsy and other seizure causing disorders, who cannot rely on traditional drugs for successful treatment may be treated with the KD. 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. As demonstrated by several studies, the KD is an effective treatment in reducing the number of seizures in these patients.
Ketovie Peptide is a ready-to-use, nutritionally complete formula. It has a 4:1 (four parts fat to 1 part protein and is fortified with vitamins and minerals. Children currently tube fed and in whom a ketogenic diet is indicated (3-16 years of age, both male and female) will be given asked to consume at least 1 x 250ml carton per day for 7 days as part of their KD therapy. The patient or their caregiver will record the quantity and time each Ketovie formula is consumed and answer a series of questions regarding the daily experience (smell, texture, ease of use, if any G.I upset.REC name
London - Bloomsbury Research Ethics Committee
REC reference
20/LO/1000
Date of REC Opinion
16 Sep 2020
REC opinion
Unfavourable Opinion