Status:
TERMINATED
Betaquik as an Adjunct to Dietary Management of Epilepsy in Adults on the Modified Atkins Diet
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Vitaflo International, Ltd
Conditions:
Epilepsy
Epilepsy Intractable
Eligibility:
All Genders
18+ years
Phase:
NA
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 trig...
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 trig...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03790436
Start Date
September 14 2018
End Date
December 31 2021
Last Update
May 31 2022
Active Locations (1)
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1
Los Angeles County + University of Southern California (LAC+USC) Medical Center
Los Angeles, California, United States, 90033