Diet-induced Elevations in LDL-C and Progression of Atherosclerosis (Keto-CTA)
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ClinicalTrials.gov Identifier: NCT05733325 |
Recruitment Status :
Completed
First Posted : February 17, 2023
Last Update Posted : March 19, 2024
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Tracking Information | |||||
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First Submitted Date | February 8, 2023 | ||||
First Posted Date | February 17, 2023 | ||||
Last Update Posted Date | March 19, 2024 | ||||
Actual Study Start Date | October 18, 2021 | ||||
Actual Primary Completion Date | February 12, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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).
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Diet-induced Elevations in LDL-C and Progression of Atherosclerosis | ||||
Official Title | Diet-induced Elevations in LDL-C and Progression of Atherosclerosis | ||||
Brief 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). 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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
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). | ||||
Condition | Hypercholesterolemia | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
100 | ||||
Original Estimated Enrollment | Same as current | ||||
Actual Study Completion Date | February 12, 2024 | ||||
Actual Primary Completion Date | February 12, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT05733325 | ||||
Other Study ID Numbers | CSF-A1 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Current Responsible Party | Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Citizen Science Foundation | ||||
Investigators |
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PRS Account | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | ||||
Verification Date | March 2024 |