Clinical trial NCT03790436: Betaquik as an Adjunct to Dietary Management of Epilepsy in Adults on the Modified Atkins Diet
Official title: A Pilot Study on the Feasibility and Tolerability of Betaquik, a Special Medical Food Containing Medium Chain Triglycerides (MCT) as an Adjunct to the Dietary Management of Epilepsy and Quality of Life in Adults on the Modified Atkins Diet (MAD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Epilepsy
Epilepsy Intractable
Seizures
Seizure Disorder
Ketogenic Dieting
Ketosis
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Vitaflo International, Ltd
First posted: 2018-12-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to measure adherence and quality of life in adults with intractable epilepsy following the Modified Atkins Diet (MAD) with Betaquik, a ready-to-use medium chain triglyceride (MCT) emulsion, as an adjunct to the MAD.

Detailed description: The purpose of this pilot study is to measure adherence and quality of life in adults with intractable epilepsy following the Modified Atkins Diet (MAD) with Betaquik, a ready-to-use medium chain triglyceride (MCT) emulsion, as an adjunct to the MAD.

The participants dietitian will recommend an appropriate daily intake of Betaquik based on individual requirements. Participants will be asked to gradually introduce Betaquik into the diet up to the target volume advised by the dietitian. Participants will then incorporate the target volume of Betaquik into their diet and gradually increase carbohydrate intake up to a maximum tolerated level and continue on the management regime until the end of the 26-week period. At the end of the 26-week period participants will undergo a Betaquik washout. In order to mitigate any impact of Betaquik tapering dietary effectiveness and sustained ketosis, carbohydrate intake will be reduced concurrently to the original 20-30 grams daily. This will continue for an additional 26-weeks (totaling 52-weeks). Both Betaquik introduction and tapers will occur under the direction of their dietitian with their daily intake under weekly review for the duration of the study. Vitaflo International Ltd. will supply Betaquik directly to the participants homes free of charge. Participants will be provided with a 28-day supply of Betaquik renewed every four weeks.

The objective of this study is to evaluate the acceptability, tolerance and adherence of the MAD including MCT - Betaquik in participants with a diagnosis of epilepsy.

This is an exploratory pilot study to evaluate the gastrointestinal tolerance, palatability and participant adherence, over a 52-week period, of the MAD with and without Betaquik, for the dietary management of participants with epilepsy.

Participants will be asked to collect daily information on any incidence of the following for the first 3 months and weekly thereafter:

* Diarrhea and/or constipation as measured by stool frequency, color and consistency
* Bloating and/or distension
* Nausea and/or vomiting
* Burping/flatulence/regurgitation
* Abdominal discomfort/pain

If participants report any of the above then additional questions about the timing, duration, cause and seriousness/severity of any adverse effects are to be recorded in the diary.

At the end of the 52-weeks all final questionnaires will be completed including those assessing quality of life, clinical epilepsy status, dietary intake and adherence, Betaquik and dietary carbohydrate intake and Betaquik tolerability. Final blood and urine samples will be taken for clinical safety assessment and routine anthropometry measurements taken.

Statistics and Plans for Analysis: This is an exploratory pilot study and its primary aim is to determine the acceptability, adherence and tolerance of the MAD with Betaquik as an adjunct therapy. A t-test and chi-square will be used with the quantitative measures, under the direction of a biostatistician. Qualitative measures will be described in a narrative summarizing the study outcomes.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of epilepsy; suffering from recurrent seizures (\> or equal to 2 seizures per month) despite at least two anticonvulsant medication trials.
* Aged 18 years and above.
* Not on the ketogenic diet.
* Absence of any metabolic or mitochondrial disorder that precludes the use of MCT and the ketogenic diet.
* Willingly given, written, informed consent from the patient or caregiver.
* Ability to comply with study protocol and keep written records.

Exclusion Criteria:

* Non-compliant with previously recommended treatments.
* Significantly underweight (BMI \<18.5), untreated dysphagia, or severe gastroesophageal reflux.
* Kidney disease, including history of nephrolithiasis.
* Uncontrolled or untreated hypercholesterolemia (\>300mg/dL) or hypertriglyceridemia (\>200mg/dL) within the last two years.
* Prior use of Betaquik at any time for any duration.
* Any serious medical, psychological, or social condition precluding the study intervention.
* Use of additional macro/micronutrient supplement during the study period, unless clinical indicated and prescribed by the investigator (must be recorded electronic medical records).
* Women who are pregnant/breastfeeding at the start of the study or planning to become pregnant during the study period.
* N.B.: Women who become pregnant unexpectedly during this study may, in consultation with their doctor, continue on the study's dietary product if they wish but will not have any investigations that would not normally be carried out during pregnancy.

Primary outcomes:
measure: Adherence to the MAD supplemented with Betaquik compared to previously reported historical adherence with the MAD with no MCT added.
timeFrame: up to 52 weeks
Secondary outcomes:
measure: Impact of Childhood Neurologic Disability Scale (ICNDS)
timeFrame: up to 52 weeks
measure: Zarit Burden Interview - Short Form
timeFrame: up to 52 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County + University of Southern California (LAC+USC) Medical Center
state: California
Study officials:
References: