Mechanism of Ketogenic Diet-Induced Hypercholesterolemia
1 other identifier
interventional
100
1 country
1
Brief Summary
Very-low carbohydrate ketogenic diets can dramatically increase blood cholesterol levels, particularly in normal-weight people, for reasons that are not well understood. This study will enroll normal-weight adults, will identify "responders" who develop high cholesterol on a ketogenic diet, and will measure rates of production and removal of certain types of cholesterol-carrying particles called lipoproteins in responders. The results will clarify the mechanism by which a ketogenic diet can cause high cholesterol in certain susceptible people.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 24, 2025
CompletedFirst Submitted
Initial submission to the registry
March 10, 2025
CompletedFirst Posted
Study publicly available on registry
March 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2030
March 23, 2026
March 1, 2026
5.8 years
March 10, 2025
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VLDL-ApoB100 production rate
Determined by using plasma and VLDL-ApoB100 leucine isotopic enrichment and compartmental modeling
Immediately after the 4-week ketogenic diet intervention period and immediately after the 4-week control diet intervention period.
Secondary Outcomes (18)
VLDL-ApoB100 fractional catabolic rate
Immediately after the 4-week ketogenic diet intervention period and immediately after the 4-week control diet intervention period.
IDL-ApoB100 production rate
Immediately after the 4-week ketogenic diet intervention period and immediately after the 4-week control diet intervention period.
IDL-ApoB100 fractional catabolic rate
Immediately after the 4-week ketogenic diet intervention period and immediately after the 4-week control diet intervention period.
LDL-ApoB100 production rate
Immediately after the 4-week ketogenic diet intervention period and immediately after the 4-week control diet intervention period.
LDL-ApoB100 fractional catabolic rate
Immediately after the 4-week ketogenic diet intervention period and immediately after the 4-week control diet intervention period.
- +13 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALArm A will complete the Ketogenic Diet intervention first, followed by the Control Diet intervention after a 4-week washout period.
B
EXPERIMENTALArm B will complete the Control Diet intervention first, followed by the Ketogenic Diet intervention after a 4-week washout period.
Interventions
Participants will consume an isocaloric ketogenic diet for 4 weeks with all food provided as packed-out meals.
Participants will consume an isocaloric control diet for 4 weeks with all food provided as packed-out meals.
Eligibility Criteria
You may qualify if:
- age ≥ 18 and \< 40 years
- BMI ≥ 18.5 and \< 25.0 kg/m2
- baseline serum LDL-c \< 150 mg/dL (\< 3.9 mmol/L)
- baseline serum TG \< 100 mg/dL (\< 1.1 mmol/L)
- HbA1c ≤ 5.6%.
You may not qualify if:
- personal or family history of familial hypercholesterolemia
- current use of lipid-lowering drugs
- currently on a ketogenic diet and unwilling to change diet
- current tobacco use
- hypertension
- prediabetes or diabetes
- elevated Lp(a) \> 6.5% of ApoB-containing lipoproteins at baseline
- oral contraceptive use
- contraindication to heparin
- known atherosclerotic cardiovascular disease
- unwilling to abstain from alcohol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Max C Petersen, M.D., Ph.D.
Washington University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2025
First Posted
March 25, 2025
Study Start
February 24, 2025
Primary Completion (Estimated)
November 30, 2030
Study Completion (Estimated)
November 30, 2030
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be made available upon peer-reviewed publication of the study results or earlier as required by the study sponsor and/or funding sources.
- Access Criteria
- FAIR Data Sharing protocols will be applied so that the data will be Findable, Accessible, Interoperable, and Re-usable.
All raw data used to generate descriptive statistics presented in manuscripts incorporating results generated from this study will be included as supplemental data files as and when required. Fully de-identified raw data, including all outcome measures and tracer enrichments from kinetic studies will be available in .csv format, which can be manipulated by many free and commercial software packages. Individual-level data will be shared as allowed by informed consent agreements approved by the Institutional Review Board (IRB).