Ketogenic Diet Drink Study

• ClinicalTrials.gov Identifier: NCT03196271
• Recruitment Status: Completed
• First Posted: June 22, 2017
• Last Update Posted: July 8, 2019
• Sponsor: Nutricia UK Ltd
• Information provided by (Responsible Party): Nutricia UK Ltd

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Intractable Epilepsy	Dietary Supplement: Ketocal 2.5:1	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluating the Tolerance, Compliance, Acceptability and Safety of Ketocal 2.5:1 LQ, 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
• Actual Study Start Date: January 4, 2017
• Actual Primary Completion Date: December 10, 2018
• Actual Study Completion Date: December 10, 2018

Arms and Interventions

Arm	Intervention/treatment
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.	Dietary Supplement: 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).

Outcome Measures

Primary Outcome Measures :

1. Gastrointestinal tolerance [ Time Frame: Throughout study (59 days) ]
   GI tolerance will be recorded throughout the study via standardised questionaire

Secondary Outcome Measures :

1. Compliance with feed prescription [ Time Frame: Throughout intervention period (28 days) ]
   Compliance with the study product will be assessed daily throughout the study intervention period by recording how much feed was consumed in mls and comparing this to the amount patients have been prescribed by their Dietitian.
2. Acceptability and Ease of Use [ Time Frame: Measured on day 28 to represent 4 week baseline period, and also measured on day 59 (reflecting 4 week intervention period) ]
   Acceptability and ease of use will be assessed by questionnaire completed by the parent/carer at the end of the control period (Day 28) for the KD, and at the end of the intervention period (Day 56) for both the diet as a whole and the study product alone.
3. Adverse events and Seizures [ Time Frame: Throughout study (59 days) ]
   All adverse events and seizures will be monitored throughout the study.
4. Nutrient intake [ Time Frame: Throughout study (59 days) ]
   Food diaries and 24hr recalls during baseline, control and intervention periods
5. Height [ Time Frame: 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59)) ]
   Height (cm)
6. Weight [ Time Frame: 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59)) ]
   Weight (kg)
7. Ketone levels [ Time Frame: 59 days. ]
   Blood ketone levels captured via fingerprick blood test 9 days (3 in baseline, 3 in control period and 3 day in the intervention period), twice a day. All other ketone levels alo recorded

Eligibility Criteria

• Ages Eligible for Study: 8 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United Kingdom

North Bristol NHS Trust

Bristol, Bs105nb, United Kingdom

University Hospitals Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom, S166YD

NHS Grampian

Aberdeen, United Kingdom, AB156RE

Birmingham and Solihull Mental Health NHS Foundation Trust

Birmingham, United Kingdom, B13RB

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, United Kingdom, B46NH

University Hospitals Bristol NHS Foundation Trust

Bristol, United Kingdom, BS13NU

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

NHS Tayside

Dundee, United Kingdom, DD19SY

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom, NE77DN

Sponsors and Collaborators

Nutricia UK Ltd

Investigators

• Study Director: Rebecca Stratton, PhD; Nutricia, University of Southampton.

More Information

• Responsible Party: Nutricia UK Ltd
• ClinicalTrials.gov Identifier: NCT03196271
• Other Study ID Numbers: K251 Study
• First Posted: June 22, 2017
• Last Update Posted: July 8, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Epilepsy; Drug Resistant Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases