Ketogenic Diet for High Cholesterol

Overseen By Nikki Plassmeyer, M.A., R.D.N., L.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Lipid-lowering drugs, Oral contraceptives

Disqualifiers: Hypertension, Diabetes, Tobacco use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are currently using lipid-lowering drugs, you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What data supports the effectiveness of the treatment Ketogenic Diet for High Cholesterol?

Some studies suggest that while the ketogenic diet can initially increase cholesterol levels, modifications to the diet can help control these levels over time. In children with high cholesterol, the diet led to a reduction in cholesterol levels after adjustments, indicating potential for managing cholesterol with careful monitoring. ^{1 2 3 4 5}

Is the ketogenic diet safe for people with high cholesterol?

The ketogenic diet can cause a significant increase in LDL cholesterol (a type of 'bad' cholesterol) in some people, especially those who are lean or have a genetic predisposition to cholesterol issues. It's important to monitor cholesterol levels closely if you follow this diet, as some individuals may experience extreme changes. ^{1 3 6 7 8}

How does the ketogenic diet treatment for high cholesterol differ from other treatments?

The ketogenic diet is unique because it involves a high-fat, low-carbohydrate approach that can lead to significant changes in cholesterol levels, including potential increases in LDL (bad cholesterol) and decreases in HDL (good cholesterol). Unlike standard treatments that often involve medication, this diet requires careful monitoring of lipid levels due to its variable effects on individuals, particularly those who are lean or have specific genetic predispositions. ^{1 2 3 6 9}

What is the purpose of this trial?

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.

Research Team

Max C Petersen, M.D., Ph.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for normal-weight adults who experience a significant increase in cholesterol levels when following a very-low carbohydrate ketogenic diet. The study aims to identify 'responders'—individuals whose cholesterol levels rise—and analyze their lipoprotein metabolism.

Inclusion Criteria

BMI must be between 18.5 and 25.0 kg/m2

Baseline serum LDL-c must be less than 150 mg/dL (less than 3.9 mmol/L)

HbA1c must be less than or equal to 5.6%

Exclusion Criteria

I have prediabetes or diabetes.

I have been diagnosed with heart disease related to artery blockage.

Current tobacco use

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

1 visit (in-person)

Dietary Intervention

Participants undergo two separate 4-week dietary interventions (ketogenic diet and control diet) in a randomized crossover design with a 4-week washout period between interventions

12 weeks

Multiple visits (in-person) for meal provision and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ketogenic Diet

Trial Overview The study compares the effects of a ketogenic diet versus a control diet on blood cholesterol levels. It focuses on how these diets influence the production and removal of lipoproteins, which carry cholesterol through the bloodstream.

Participant Groups

Group I: B Experimental Treatment 2 Interventions

Arm B will complete the Control Diet intervention first, followed by the Ketogenic Diet intervention after a 4-week washout period.

Group II: A Experimental Treatment 2 Interventions

Arm A will complete the Ketogenic Diet intervention first, followed by the Control Diet intervention after a 4-week washout period.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Findings from Research

The ketogenic diet (KD) can lead to significant increases in total cholesterol and low-density lipoprotein (LDL) cholesterol, especially in lean individuals, highlighting the need for careful lipid monitoring during the diet.

Improvements in cholesterol levels were observed after discontinuing the KD, suggesting that while the diet may aid in weight loss and glycemic control, it can have adverse effects on lipid profiles that need to be managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profound Elevation in LDL Cholesterol Level Following a Ketogenic Diet: A Case Series. Crosier, R., McPherson, R.[2022]

The ketogenic diet (KD) is effective in controlling drug-refractory seizures in children and adolescents, but it is associated with recurrent dyslipidemia, particularly hypercholesterolemia, which can negatively impact lipid profiles.

While KD has clear benefits for seizure control, it may increase cardiometabolic risk due to structural changes in low-density lipoprotein (LDL) particles, suggesting a need for further investigation into lipid and oxidative metabolism in patients on this diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic diet in epileptic children: impact on lipoproteins and oxidative stress. Lima, PA., de Brito Sampaio, LP., Damasceno, NR.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Profound Elevation in LDL Cholesterol Level Following a Ketogenic Diet: A Case Series. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Can children with hyperlipidemia receive ketogenic diet for medication-resistant epilepsy? [2017]

3. England pubmed.ncbi.nlm.nih.gov

Ketogenic diet in epileptic children: impact on lipoproteins and oxidative stress. [2017]

4. Italy pubmed.ncbi.nlm.nih.gov

The effects of classic ketogenic diet on serum lipid profile in children with refractory seizures. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Management and risk factors for dyslipidemia with the ketogenic diet. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Extreme Hypercholesterolemia Following a Ketogenic Diet: Exaggerated Response to an Increasingly Popular Diet. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Long term effects of ketogenic diet in obese subjects with high cholesterol level. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Dramatic elevation of LDL cholesterol from ketogenic-dieting: A Case Series. [2023]

9. Australia pubmed.ncbi.nlm.nih.gov

Effect of a high energy, low carbohydrate diet on serum levels of lipids and lipoproteins. [2021]