Ketogenic Diet Drink Study

Launched by NUTRICIA UK LTD · Jun 20, 2017

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• 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)