EpilepsyNCT03790436
Betaquik as an Adjunct to Dietary Management of Epilepsy in Adults on the Modified Atkins Diet
A study testing Betaquik in people with Epilepsy and Epilepsy Intractable, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Epilepsy Intractable, Seizures
- What is being tested?
- Betaquik
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles County + University of Southern California (LAC+USC) Medical Center
Los Angeles, California, 90033
About this study
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)
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.
Read the 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.
- Conditions
- Epilepsy, Epilepsy Intractable, Seizures, Seizure Disorder, Ketogenic Dieting, Ketosis
- Being tested
- Betaquik
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy, Seizures, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetaquikDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Betaquik | Experimental | Not described Receives: Dietary Supplement: Betaquik |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 52 weeks
Secondary outcomes (2)
Impact of Childhood Neurologic Disability Scale (ICNDS)
The Impact of Childhood Neurologic Disability Scale (ICNDS) measures factors that play a significant impact on the life of individuals with epilepsy: epilepsy, cognition, behavioral, and physical/neurologic function. Each factor has the same 11 questions applicable to the past 3 months of the individuals life which are scored 0 (not at all) to 3 (a lot). The maximum score in each factor is 33 and for the overall scale the score is 132; higher scores indicate greater impact. The Impact of Childhood Neurologic Disability Scale (ICNDS) includes a numeric scale of the child's overall quality of life ranging from 1 (poor) to 6 (excellent).
Measured: up to 52 weeks
Zarit Burden Interview - Short Form
The Zarit Burden Interview - Short Form has 12 items which are scored as 0 (never) to 4 (nearly always). The total score ranges 0 to 48. A score for no to mild caregiver burden has a score of 0-10, mild to moderate caregiver burden a score of 10-20, and high caregiver burden a score >20.
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start14 Sep 2018
- Primary completion30 Oct 2021
- Study completion31 Dec 2021
Why it stopped: We no longer have Ketogenic Dietician coverage/access.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Vitaflo International, Ltd
- Responsible party
- Principal investigator, Arthur Partikian, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790436
- Sponsor's protocol ID
- HS-17-01011
- Status last verified
- May 2022
- First submitted
- 20 Nov 2018
- Last updated
- 31 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03790436
- Acronym / sponsor ID
- HS-17-01011
- Conditions
- Epilepsy, Epilepsy Intractable, Seizures, Seizure Disorder, Ketogenic Dieting, Ketosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We no longer have Ketogenic Dietician coverage/access.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Vitaflo International, Ltd
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Betaquik | Experimental | Dietary Supplement: Betaquik |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BetaquikStudy 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. | Dietary supplement | Betaquik |
Primary outcome
Adherence to the MAD supplemented with Betaquik compared to previously reported historical adherence with the MAD with no MCT added.
Time frame: up to 52 weeks
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.
2 secondary outcomes
Impact of Childhood Neurologic Disability Scale (ICNDS)
Time frame: up to 52 weeks
Zarit Burden Interview - Short Form
Time frame: up to 52 weeks
Results and safety
The study was stopped early (reason given: We no longer have Ketogenic Dietician coverage/access.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betaquik in people with Epilepsy and Epilepsy Intractable, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We no longer have Ketogenic Dietician coverage/access.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the MAD supplemented with Betaquik compared to previously reported historical adherence with the MAD with no MCT added. (time frame: up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.