Ketogenic Diet Drink Study

An evaluation of the tolerance, compliance, acceptability and safety of 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.

Study is conducted over 59 days:

3 day baseline period - Patient continues on whatever dietary regimen they were on before joining the study (this may be a ketogenic diet for existing patients).

28 day control period - Patient begins ketogenic diet (if they are not already on one), and continues this for 28 days WITHOUT the study product. Patients already on a ketogenic diet continue this as normal.

28 day intervention period - A set amount of the study product is incorporated into the patient's ketogenic diet.

Data is captured by the HCP in the case report form at baseline, mid study and end of intervention, and by the patient daily throughout in a patient questionnaire.

Inclusion criteria

• Male or female
• 8 years of age or older
• Diagnosed with intractable epilepsy or another disorder where the KD is indicated
• Motivated to follow the KD for at least the duration of the trial period
• Either currently on a KD, or referred to start a KD
• Likely to benefit from Ketocal 2.5:1
• Written informed consent from patient and/or parent/carer, or completed consultee declaration form
• Willing to take finger prick blood samples to measure ketone levels

Exclusion criteria

• Being pregnant or planning pregnancy
• Requiring parenteral nutrition
• Major hepatic or renal dysfunction
• Participation in other clinical intervention studies within 1 month prior to entry of this study
• Allergy to any of the study product ingredients
• Investigator concern around willingness/ability of patient or parent/carer to comply with protocol requirements
• Any contraindications for the use of the ketogenic diet
• Significantly underweight (Body Mass Index <18.5)