Ketogenic Diet Drink Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-04

Study Completion Date

2018-12-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intractable Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Study arm

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.

Group Type OTHER

Ketocal 2.5:1

Intervention Type DIETARY_SUPPLEMENT

A ketogenic feed for the dietary management of intractable epilepsy is given over a period of four weeks, after a control period of 4 weeks. The amount of the feed given is determined by the Dietitian and/or Doctor responsible for the patient's care (at least one carton per day).

Interventions

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Ketocal 2.5:1

A ketogenic feed for the dietary management of intractable epilepsy is given over a period of four weeks, after a control period of 4 weeks. The amount of the feed given is determined by the Dietitian and/or Doctor responsible for the patient's care (at least one carton per day).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)

Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No