Ketogenic Diet Drink Study

Nutricia

Status: Completed

Conditions: Intractable Epilepsy

Treatments: Dietary Supplement: Ketocal 2.5:1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03196271

K251 Study

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 26 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Study arm

Other group

Description:

One single arm, consisting of a 3 day baseline period, a 28 day control period and a 28 day intervention period (Ketocal 2.5:1), in that order.

Treatment:

Dietary Supplement: Ketocal 2.5:1