Betaquik as an Adjunct to Dietary Management of Epilepsy in Adults on the Modified Atkins Diet

NCT03790436 | Terminated

• 1 other identifier: HS-17-01011
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Epilepsy Intractable; Seizures; Seizure Disorder; Ketogenic Dieting; Ketosis

Outcome Measures

Primary Outcomes (1)

• Adherence to the MAD supplemented with Betaquik compared to previously reported historical adherence with the MAD with no MCT added.

  Adherence will be measured by the percent of time the participant drinks Betaquik averaged over 3 months. The participant will be considered adherent if they drink the required amount on more than 80% of the prescribed days.

  up to 52 weeks

Secondary Outcomes (2)

• Impact of Childhood Neurologic Disability Scale (ICNDS)

  up to 52 weeks

• Zarit Burden Interview - Short Form

  up to 52 weeks

Study Arms (1)

Betaquik

EXPERIMENTAL

Dietary Supplement: Betaquik

Interventions

Betaquik DIETARY_SUPPLEMENT

Study dietitian will advise each participant on target volume of Betaquik (45g MCT, 225mL Betaquik). Consuming too much MCT too quickly may cause gastrointestinal discomfort such as abdominal pain or diarrhea, this is related to its assimilation to the body. Any symptoms that do occur normally resolve in the majority of patients, and with time and persistence, GI tolerance is usually established. Therefore the study dietitian will advise on a gradual systematic introduction to minimize any adverse effects. The daily-tolerated amount will be divided into 3-4 equal portions, taken regularly throughout the day. subjects will be advised to always take Betaquik with food, as part of meals and snacks, to help promote gastrointestinal tolerance. The goal is within the first 4 weeks participants will have reached their tolerated target volume of Betaquik.

Betaquik

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• Vitaflo International, Ltd: collaborator

Study Sites (1)

Los Angeles County + University of Southern California (LAC+USC) Medical Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Epilepsy; Drug Resistant Epilepsy; Seizures; Ketosis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: December 31, 2018
• Study Start: September 14, 2018
• Primary Completion: October 30, 2021
• Study Completion: December 31, 2021
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

US (1)