Ketogenic Diet Drink Study

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

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 Overview

• Status: Completed
• Conditions: Intractable Epilepsy
• Intervention / Treatment: Dietary supplement: Ketocal 2.5:1

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Aberdeen, United Kingdom, AB156RE
    • NHS Grampian
  • Birmingham, United Kingdom, B13RB
    • Birmingham and Solihull Mental Health NHS Foundation Trust
  • Birmingham, United Kingdom, B46NH
    • Birmingham Women's and Children's NHS Foundation Trust
  • Bristol, United Kingdom, BS13NU
    • University Hospitals Bristol NHS Foundation Trust
  • Cambridge, United Kingdom
    • Cambridge University Hospitals NHS Foundation Trust
  • Dundee, United Kingdom, DD19SY
    • NHS Tayside
  • Newcastle upon Tyne, United Kingdom, NE77DN
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • Bs105nb
    • Bristol, Bs105nb, United Kingdom
      • North Bristol NHS Trust
  • Hampshire
    • Southampton, Hampshire, United Kingdom, S166YD
      • University Hospitals Southampton NHS Foundation Trust

Participation Criteria

Eligibility Criteria

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal tolerance	GI tolerance will be recorded throughout the study via standardised questionaire	Throughout study (59 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance with feed prescription	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.	Throughout intervention period (28 days)
Acceptability and Ease of Use	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.	Measured on day 28 to represent 4 week baseline period, and also measured on day 59 (reflecting 4 week intervention period)
Adverse events and Seizures	All adverse events and seizures will be monitored throughout the study.	Throughout study (59 days)
Nutrient intake	Food diaries and 24hr recalls during baseline, control and intervention periods	Throughout study (59 days)
Height	Height (cm)	59 days (measured at start (day 1), middle (day 31) and end of this period (day 59))
Weight	Weight (kg)	59 days (measured at start (day 1), middle (day 31) and end of this period (day 59))
Ketone levels	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	59 days.

Collaborators and Investigators

• Sponsor: Nutricia UK Ltd
• Investigators: Study Director: Rebecca Stratton, PhD, Nutricia, University of Southampton.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2017
• Primary Completion (Actual): December 10, 2018
• Study Completion (Actual): December 10, 2018

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 5, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: K251 Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No