HypercholesterolemiaKeto-CTANCT05733325
Diet-induced Elevations in LDL-C and Progression of Atherosclerosis
An observational study of Hypercholesterolemia, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial summary
This is an observational study examining the progression of subclinical coronary atherosclerosis in healthy participants who have an elevated LDL-C (above 190mg/dl) secondary to diet not associated with genetic familial hypercholesterolemia (FH). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2021to 12 Feb 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Lean Mass Hyper-Responders: The target population are those who experience significant increases in LDL-C on VLC/KDs whilst also being healthy and relatively lean (BMI <30mg/kg2 and waist circumference <102 cm and 88 cm for men and women respectively if BMI 25-30 mg/kg2). These individuals are referred to as lean mass hyper-responders (LMHRs) with diet-induced hypercholesterolemia (DIH).
Who may be able to join
- Age ≥ 18 years old
- Had an LDL cholesterol of 160 mg/dL or below from most recent labs taken before adopting a low carb diet (requires documentary evidence)
- Has seen an increase of LDL cholesterol to 190 mg/dL or above from most recent labs on current diet **
- Has LDL cholesterol levels at least 50% or greater compared to most recent documented value prior to starting the diet.
- On low carb, ketogenic diet for the last 24 months or more.
- HDL-C ≥ 60 mg/dL and triglyceride level ≤ 80 mg/dL **
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- Willingness to participate in the study and ability to sign informed consent
- In the investigator's opinion subjects are willing and likely able to comply with scheduled visits, laboratory tests, and other study procedures.
- Normal to low BP (systolic ≤ 130 mm Hg or diastolic ≤ 80 mm Hg) at screening/baseline (visit 1).
- Fasting glucose < 110 mg/dL and HbA1c < 6.0%) **
- hsCRP < 2 mg/L **
- No prior diagnosis of Type 2 Diabetes
- No prior use of anti-diabetic medication
- Not currently taking lipid lowering supplements or medications including statins, red yeast rice, garlic, ezetimibe, berberine
- Requires documentary evidence
Who cannot join
- Untreated hypothyroidism (TSH > 10)
- Use of medications that elevated LDL-C (anabolic steroids, isotretinoin, immunosuppressants, amiodarone, thiazide diuretics, glucocorticoids, or thiazolidinediones)
- Pregnancy
- Has smoked more than 100 cigarettes in lifetime
- An ongoing inflammatory disorder (e.g. psoriatic arthritis)
- History of atherosclerotic heart disease
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- Known history of molecularly defined Familial Hypercholesterolemia
- BMI = or > 30 kg/m^2 (or waist circumference > 88 cm or > 102 cm for women and men respectively if BMI between 25-30 kg/m^2)
- Renal insufficiency (calculated creatinine clearance of <50 ml per minute, MDRD (modification of Diet in Renal Disease) equation).
- Use of Lipid lowering medication (Statins, etc) at the time of most recent labs taken before starting Ketogenic diet.
- AST (Aspartate aminotransferase) or ALT (Alanine Transaminase) >2 times the upper limit of normal (ULN) at the Screening visit (V1), or a total bilirubin >1.5 times the ULN unless the subject has a history of Gilbert's.
- Subject unable to provide medical records indicating lab results before starting a keto- diet.
- Subject has a history of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Note (1) A subject with a history of malignancy >5 years prior to signing informed consent should have no evidence of residual or recurrent disease.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality at the Screening visit (V1) that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
- Subjects with known allergy to iodinated contrast material
- Subject is pregnant or breast-feeding, or is expecting to conceive during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute)
Torrance, California, 90502
About this study
This is an observational study examining the progression of subclinical coronary atherosclerosis in healthy participants who have an elevated LDL-C (above 190mg/dl) secondary to diet not associated with genetic familial hypercholesterolemia (FH). This study participants are classified to be Lean-Mass-Hyper-Responder (LMHR).
Read the detailed description
This is an observational study examining the progression of subclinical coronary atherosclerosis in healthy participants who have an elevated LDL-C (above 190mg/dl) secondary to diet not associated with genetic familial hypercholesterolemia (FH). The investigator proposes to measure subclinical atherosclerosis as measured by low-dose prospective ECG-triggered cardiac computed tomographic angiography (CCTA) - in order to evaluate the rates of progression of atherosclerosis over 1 year. These participants will have voluntarily been eating a very low carbohydrate or ketogenic diet (VLC/KD) for at least 24 months, with evidence of significant elevations in LDL-C after commencing the diet.
Participants will be recruited online through social media including Facebook groups discussing VLC/KDs. The target population are those who experience significant increases in LDL-C on VLC/KDs whilst also being healthy and relatively lean (BMI <30mg/kg2 and waist circumference <102 cm and 88 cm for men and women respectively if BMI 25-30 mg/kg2).
Once participants present their interest to participate in the study by responding to the social media flyer and made an attempt to get in touch with the study site, study staff will reach out to the participant over the phone using an IRB (Institutional Review Board) approved screening questionnaire to verify eligibility and answer any question about the study. Once subject confirms that he/she is interested to participate, they will be informed that a copy of the Informed Consent Form (ICF) will be emailed to them using a HIPAA compliant DocuSign (application to sign a document electronically) portal. Subjects are required to review and electronically sign the ICF. Once an ICF has been signed, subject will be asked to upload the relevant medical records to the HIPAA compliant RedCap portal as documentary evidence to the lipid levels. Once the study team reviews the medical records/lab results and confirm the subject eligibility, the travel arrangements to the study site for the in-person baseline visit will be made.
Study participants will have total of 2 in-person study visits (Baseline - visit 1 and 12 month - visit 2) and will have a 6 month - phone visit in between.
During the baseline site visit, the participants will be asked to take a genetic test, blood draw, ECG and CCTA. Study staff will also be collecting vital signs, medical history, physical exam and questionnaire. Study participants will be asked to measure their morning blood ketone and glucose levels every day and report the results using KetoMojo application.
Subjects will be informed about the possible risk associated with the study participation including radiation from the CT scan/CCTA, risks associated with the taking Beta-blocker, Calcium channel blocker, Nitroglycerin as well as IV insertion.
Recruitment will take place over 6 months, with follow up over 12 months. The study design calls for the enrollment of 100 eligible subjects.
- Conditions
- Hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in total non-calcified coronary plaque volume
Percent change in total non-calcified coronary plaque volume from baseline (start of the study) till the final visit will be measured using Coronary Computed Tomography Angiography (CCTA).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start18 Oct 2021
- Primary completion12 Feb 2024
- Study completion12 Feb 2024
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.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Citizen Science Foundation
- Responsible party
- Principal investigator, Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- Matthew A Budoff, MD, Principal investigator, The Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733325
- Sponsor's protocol ID
- CSF-A1
- Acronym
- Keto-CTA
- Status last verified
- Mar 2024
- First submitted
- 8 Feb 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Soto-Mota A, Norwitz NG, Manubolu VS, Kinninger A, Wood TR, Earls J, Feldman D, Budoff M. Longitudinal Data From the KETO-CTA Study: Plaque Predicts Plaque, ApoB Does Not. JACC Adv. 2025 Jul;4(7):101686. doi: 10.1016/j.jacadv.2025.101686. Epub 2025 Apr 7.
PubMed 40192608
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet-induced Elevations in LDL-C and Progression of Atherosclerosis
- ClinicalTrials.gov ID
- NCT05733325
- Acronym / sponsor ID
- Keto-CTA / CSF-A1
- Conditions
- Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Collaborators
- Citizen Science Foundation
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 17 Feb 2023 (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.
This is an observational study examining the progression of subclinical coronary atherosclerosis in healthy participants who have an elevated LDL-C (above 190mg/dl) secondary to diet not associated with genetic familial hypercholesterolemia (FH). This study participants are classified to be Lean-Mass-Hyper-Responder (LMHR).
Detailed description
This is an observational study examining the progression of subclinical coronary atherosclerosis in healthy participants who have an elevated LDL-C (above 190mg/dl) secondary to diet not associated with genetic familial hypercholesterolemia (FH). The investigator proposes to measure subclinical atherosclerosis as measured by low-dose prospective ECG-triggered cardiac computed tomographic angiography (CCTA) - in order to evaluate the rates of progression of atherosclerosis over 1 year. These participants will have voluntarily been eating a very low carbohydrate or ketogenic diet (VLC/KD) for at least 24 months, with evidence of significant elevations in LDL-C after commencing the diet.
Participants will be recruited online through social media including Facebook groups discussing VLC/KDs. The target population are those who experience significant increases in LDL-C on VLC/KDs whilst also being healthy and relatively lean (BMI <30mg/kg2 and waist circumference <102 cm and 88 cm for men and women respectively if BMI 25-30 mg/kg2).
Once participants present their interest to participate in the study by responding to the social media flyer and made an attempt to get in touch with the study site, study staff will reach out to the participant over the phone using an IRB (Institutional Review Board) approved screening questionnaire to verify eligibility and answer any question about the study. Once subject confirms that he/she is interested to participate, they will be informed that a copy of the Informed Consent Form (ICF) will be emailed to them using a HIPAA compliant DocuSign (application to sign a document electronically) portal. Subjects are required to review and electronically sign the ICF. Once an ICF has been signed, subject will be asked to upload the relevant medical records to the HIPAA compliant RedCap portal as documentary evidence to the lipid levels. Once the study team reviews the medical records/lab results and confirm the subject eligibility, the travel arrangements to the study site for the in-person baseline visit will be made.
Study participants will have total of 2 in-person study visits (Baseline - visit 1 and 12 month - visit 2) and will have a 6 month - phone visit in between.
During the baseline site visit, the participants will be asked to take a genetic test, blood draw, ECG and CCTA. Study staff will also be collecting vital signs, medical history, physical exam and questionnaire. Study participants will be asked to measure their morning blood ketone and glucose levels every day and report the results using KetoMojo application.
Subjects will be informed about the possible risk associated with the study participation including radiation from the CT scan/CCTA, risks associated with the taking Beta-blocker, Calcium channel blocker, Nitroglycerin as well as IV insertion.
Recruitment will take place over 6 months, with follow up over 12 months. The study design calls for the enrollment of 100 eligible subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Lean Mass Hyper-Responders: The target population are those who experience significant increases in LDL-C on VLC/KDs whilst also being healthy and relatively lean (BMI <30mg/kg2 and waist circumference <102 cm and 88 cm for men and women respectively if BMI 25-30 mg/kg2). These individuals are referred to as lean mass hyper-responders (LMHRs) with diet-induced hypercholesterolemia (DIH).
Key inclusion criteria (15 listed)
- Age ≥ 18 years old
- Had an LDL cholesterol of 160 mg/dL or below from most recent labs taken before adopting a low carb diet (requires documentary evidence)
- Has seen an increase of LDL cholesterol to 190 mg/dL or above from most recent labs on current diet **
- Has LDL cholesterol levels at least 50% or greater compared to most recent documented value prior to starting the diet.
- On low carb, ketogenic diet for the last 24 months or more.
Key exclusion criteria (17 listed)
- Untreated hypothyroidism (TSH > 10)
- Use of medications that elevated LDL-C (anabolic steroids, isotretinoin, immunosuppressants, amiodarone, thiazide diuretics, glucocorticoids, or thiazolidinediones)
- Pregnancy
- Has smoked more than 100 cigarettes in lifetime
- An ongoing inflammatory disorder (e.g. psoriatic arthritis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent change in total non-calcified coronary plaque volume
Time frame: 12 months
Percent change in total non-calcified coronary plaque volume from baseline (start of the study) till the final visit will be measured using Coronary Computed Tomography Angiography (CCTA).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Derived from this study: PubMed 40192608Soto-Mota A, Norwitz NG, Manubolu VS, Kinninger A, Wood TR, Earls J, Feldman D, Budoff M. Longitudinal Data From the KETO-CTA Study: Plaque Predicts Plaque, ApoB Does Not. JACC Adv. 2025 Jul;4(7):101686. doi: 10.1016/j.jacadv.2025.101686. Epub 2025 Apr 7.
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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.
Matthew A Budoff, MD principal investigator
The Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
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, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center 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 15 inclusion and 17 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: finished, as of the sponsor's last update on 19 Mar 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent change in total non-calcified coronary plaque volume (time frame: 12 months). 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 NCT05733325, 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 19 Mar 2024.