HypercholesterolemiaNCT02694094
Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy
An observational study of Hypercholesterolemia and Carotid Intimal Medial Thickness 1, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to evaluate the short term and long term effects of ketogenic diets on measures of cardiovascular health. Such measures include cholesterol levels, blood pressure, weight, and thickening of the blood vessel wall over time. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Carotid Intimal Medial Thickness 1, Seizure
- What is being tested?
- Modified Atkins or Ketogenic Diet
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants will be drawn from among participants in the Johns Hopkins Adult Epilepsy Diet Center and Johns Hopkins Epilepsy Center who are age 18 or older, with body mass index (BMI) > 18.5, and on a stable antiepileptic drug regimen for > 1 month.
Who may be able to join
- 18 years of age or older
- Body mass index (BMI) > 18.5
- Stable antiepileptic drug regimen for > 1 month.
Who cannot join
- < 18 years of age
- Body mass index (BMI) < 18.5
- Changes in antiepileptic drug regimen < 1 month prior to participation
- Previous cardiovascular event or treatment ((including myocardial infarction, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI))
- Acute pancreatitis
- Unwilling to restrict carbohydrates
- Kidney disease
- Contraindicated metabolic or mitochondrial disorder
Trial locations and contacts
1 site in 1 country.
About this study
This research is being done to evaluate the short term and long term effects of ketogenic diets on measures of cardiovascular health. Such measures include cholesterol levels, blood pressure, weight, and thickening of the blood vessel wall over time. Adults aged 18 or older who are already on a ketogenic diet for at least 12 months or who are interested in beginning on the modified Atkins diet may join.
Read the detailed description
If participants agree to be in this study, the investigators will ask the participants to do the following things:
At Initial enrollment for both longterm ketogenic diet and new modified Atkins diet participants
- Review of calendars (showing seizures) and 3-day food record
- Check height and weight, blood pressure, skin-fold thickness and waist circumference
- Standard modified Atkins diet clinic labs will be drawn as well as levels of low density lipoprotein (LDL) fractions, fatty acids, and apolipoproteins B and A-1
- Participant will receive a high-resolution ultrasound of the carotid arteries in the neck performed either the day of enrollment or within 1 month of enrollment
At follow-up clinic visits (month 3 and month 6) for new modified Atkins diet participants
- Review of calendars and food records
- Labs repeated - standard modified Atkins diet clinic labs as well as levels of low density lipoprotein (LDL) fractions, fatty acids, and apolipoproteins B and A-1
- Check height and weight, blood pressure, skin-fold thickness and waist circumference
At follow-up clinic visits (month 12 and month 24) for new modified Atkins diet participants
- Review of calendars and food records
- Labs repeated - standard modified Atkins diet clinic labs as well as levels of low density lipoprotein (LDL) fractions, fatty acids, and apolipoproteins B and A-1
- Check height and weight, blood pressure, skin-fold thickness and waist circumference
- Participants will receive a high-resolution ultrasound of the carotid arteries in the neck performed either the day of follow-up or within 1 month of follow-up
- Conditions
- Hypercholesterolemia, Carotid Intimal Medial Thickness 1, Seizure, Epilepsy, Cardiovascular Disease, Cerebrovascular Disease
- Being tested
- Modified Atkins or Ketogenic Diet
- Keywords
- cholesterol, seizure, epilepsy, ketogenic, diet
- Medical subject headings
- Hypercholesterolemia, Carotid Intimal Medial Thickness 1, Seizures, Epilepsy, Cardiovascular Diseases, Cerebrovascular Disorders, Heart Diseases, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Atkins or Ketogenic DietDietary supplement
Biochemical and vascular parameters will be compared from adults who have been on ketogenic diet therapy for > 12 months to adults naive to ketogenic diet therapy. In addition, adults naive to diet therapy who subsequently begin diet therapy will have these same parameters followed over time.
| Study group | Role | What they receive |
|---|---|---|
| Adults on Chronic ketogenic diets | Adults who have been on Modified Atkins or ketogenic diets for over 1 year Receives: Dietary Supplement: Modified Atkins or Ketogenic Diet | |
| Adults naive to ketogenic diets | Adults who have never been on Modified Atkins or ketogenic diets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in carotid artery intima-media thickness (mm) measured by carotid artery ultrasound
Carotid artery ultrasound will be used to measure the change in average intima-media thickness over time with comparisons between baseline and 12 months of diet therapy.
Measured: Baseline and 12 months post diet implementation
Change in LDL fractions (nmol/L)
The change in levels of fasting serum low density lipoprotein (LDL) fractions (nmol/L) will be measured over time with comparisons between baseline and 12 months of diet therapy.
Measured: Baseline and 12 months post diet implementation
Secondary outcomes (8)
Change in LDL fractions (nmol/L)
The change in levels of fasting serum low density lipoprotein (LDL) fractions (nmol/L) will be measured over time with comparisons between baseline and 3 months of diet therapy.
Measured: Baseline and 3 months post diet implementation
Change in apolipoproteins (mg/dL)
The change in fasting serum levels of apolipoproteins B and A-1 will be measured over time with comparisons between baseline and 3 months of diet therapy.
Measured: Baseline and 3 months post diet implementation
Change in apolipoproteins (mg/dL)
The change in fasting serum levels of apolipoproteins B and A-1 will be measured over time with comparisons between baseline and 6 months of diet therapy.
Measured: Baseline and 6 months post diet implementation
Change in apolipoproteins (mg/dL)
The change in fasting serum levels of apolipoproteins B and A-1 will be measured over time with comparisons between baseline and 12 months of diet therapy.
Measured: Baseline and 12 months post diet implementation
Change in apolipoproteins (mg/dL)
The change in fasting serum levels of apolipoproteins B and A-1 will be measured over time with comparisons between baseline and 24 months of diet therapy.
Measured: Baseline and 24 months post diet implementation
Change in LDL fractions (nmol/L)
The change in levels of fasting serum low density lipoprotein (LDL) fractions (nmol/L) will be measured over time with comparisons between baseline and 6 months of diet therapy.
Measured: Baseline and 6 months post diet implementation
Change in LDL fractions (nmol/L)
The change in levels of fasting serum low density lipoprotein (LDL) fractions (nmol/L) will be measured over time with comparisons between baseline and 24 months of diet therapy.
Measured: Baseline and 24 months post diet implementation
Change in carotid artery intima-media thickness (mm) measured by carotid artery
Carotid artery ultrasound will be used to measure the change in average intima-media thickness over time with comparisons between baseline and 24 months of diet therapy.
Measured: Baseline and 24 months post diet implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mackenzie C Cervenka, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694094
- Sponsor's protocol ID
- IRB00070557
- Status last verified
- Sep 2026
- First submitted
- 16 Feb 2016
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McDonald TJW, Diaz-Arias L, Vizthum D, Henry-Barron BJ, Schlechter H, Kossoff EH, Cervenka MC. Six-month effects of modified Atkins diet implementation on indices of cardiovascular disease risk in adults with epilepsy. Nutr Neurosci. 2022 Jul;25(7):1548-1557. doi: 10.1080/1028415X.2021.1875301. Epub 2021 Jan 23.
PubMed 33487129
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy
- ClinicalTrials.gov ID
- NCT02694094
- Acronym / sponsor ID
- IRB00070557
- Conditions
- Hypercholesterolemia, Carotid Intimal Medial Thickness 1, Seizure, Epilepsy, Cardiovascular Disease, Cerebrovascular Disease
- Keywords
- cholesterol, seizure, epilepsy, ketogenic, diet
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 29 Feb 2016 (estimated)
- 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.
This research is being done to evaluate the short term and long term effects of ketogenic diets on measures of cardiovascular health. Such measures include cholesterol levels, blood pressure, weight, and thickening of the blood vessel wall over time. Adults aged 18 or older who are already on a ketogenic diet for at least 12 months or who are interested in beginning on the modified Atkins diet may join.
Detailed description
If participants agree to be in this study, the investigators will ask the participants to do the following things:
At Initial enrollment for both longterm ketogenic diet and new modified Atkins diet participants
- Review of calendars (showing seizures) and 3-day food record
- Check height and weight, blood pressure, skin-fold thickness and waist circumference
- Standard modified Atkins diet clinic labs will be drawn as well as levels of low density lipoprotein (LDL) fractions, fatty acids, and apolipoproteins B and A-1
- Participant will receive a high-resolution ultrasound of the carotid arteries in the neck performed either the day of enrollment or within 1 month of enrollment
At follow-up clinic visits (month 3 and month 6) for new modified Atkins diet participants
- Review of calendars and food records
- Labs repeated - standard modified Atkins diet clinic labs as well as levels of low density lipoprotein (LDL) fractions, fatty acids, and apolipoproteins B and A-1
- Check height and weight, blood pressure, skin-fold thickness and waist circumference
At follow-up clinic visits (month 12 and month 24) for new modified Atkins diet participants
- Review of calendars and food records
- Labs repeated - standard modified Atkins diet clinic labs as well as levels of low density lipoprotein (LDL) fractions, fatty acids, and apolipoproteins B and A-1
- Check height and weight, blood pressure, skin-fold thickness and waist circumference
- Participants will receive a high-resolution ultrasound of the carotid arteries in the neck performed either the day of follow-up or within 1 month of follow-up
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults on Chronic ketogenic diets | – | Dietary Supplement: Modified Atkins or Ketogenic DietAdults who have been on Modified Atkins or ketogenic diets for over 1 year |
| Adults naive to ketogenic diets | – | –Adults who have never been on Modified Atkins or ketogenic diets |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be drawn from among participants in the Johns Hopkins Adult Epilepsy Diet Center and Johns Hopkins Epilepsy Center who are age 18 or older, with body mass index (BMI) > 18.5, and on a stable antiepileptic drug regimen for > 1 month.
Key inclusion criteria (3 listed)
- 18 years of age or older
- Body mass index (BMI) > 18.5
- Stable antiepileptic drug regimen for > 1 month.
Key exclusion criteria (8 listed)
- < 18 years of age
- Body mass index (BMI) < 18.5
- Changes in antiepileptic drug regimen < 1 month prior to participation
- Previous cardiovascular event or treatment ((including myocardial infarction, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI))
- Acute pancreatitis
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 |
|---|---|---|
| Modified Atkins or Ketogenic DietBiochemical and vascular parameters will be compared from adults who have been on ketogenic diet therapy for > 12 months to adults naive to ketogenic diet therapy. In addition, adults naive to diet therapy who subsequently begin diet therapy will have these same parameters followed over time. | Dietary supplement | Adults on Chronic ketogenic diets |
Primary outcome
Change in carotid artery intima-media thickness (mm) measured by carotid artery ultrasound
Time frame: Baseline and 12 months post diet implementation
Carotid artery ultrasound will be used to measure the change in average intima-media thickness over time with comparisons between baseline and 12 months of diet therapy.
Change in LDL fractions (nmol/L)
Time frame: Baseline and 12 months post diet implementation
The change in levels of fasting serum low density lipoprotein (LDL) fractions (nmol/L) will be measured over time with comparisons between baseline and 12 months of diet therapy.
8 secondary outcomes
Change in LDL fractions (nmol/L)
Time frame: Baseline and 3 months post diet implementation
Change in apolipoproteins (mg/dL)
Time frame: Baseline and 3 months post diet implementation
Change in apolipoproteins (mg/dL)
Time frame: Baseline and 6 months post diet implementation
Change in apolipoproteins (mg/dL)
Time frame: Baseline and 12 months post diet implementation
Change in apolipoproteins (mg/dL)
Time frame: Baseline and 24 months post diet implementation
Change in LDL fractions (nmol/L)
Time frame: Baseline and 6 months post diet implementation
Change in LDL fractions (nmol/L)
Time frame: Baseline and 24 months post diet implementation
Change in carotid artery intima-media thickness (mm) measured by carotid artery
Time frame: Baseline and 24 months post diet implementation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Derived from this study: PubMed 33487129McDonald TJW, Diaz-Arias L, Vizthum D, Henry-Barron BJ, Schlechter H, Kossoff EH, Cervenka MC. Six-month effects of modified Atkins diet implementation on indices of cardiovascular disease risk in adults with epilepsy. Nutr Neurosci. 2022 Jul;25(7):1548-1557. doi: 10.1080/1028415X.2021.1875301. Epub 2021 Jan 23.
- Ketogenic Diet Therapy for EpilepsyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Mackenzie C Cervenka, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia and Carotid Intimal Medial Thickness 1, run by Johns Hopkins University 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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in carotid artery intima-media thickness (mm) measured by carotid artery ultrasound (time frame: Baseline and 12 months post diet implementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02694094, which also lists 1 linked publication.
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 8 Sep 2026.