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Keto diet cholesterol mystery: scientists investigate

NCT ID NCT06894004

Knowledge-focused Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at why very-low-carb ketogenic diets can cause high cholesterol in some normal-weight people. Researchers will enroll 100 adults, identify those whose cholesterol spikes on keto, and measure how their bodies make and remove cholesterol-carrying particles. The goal is to understand the mechanism behind this effect, not to test a treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ketogenic Diet
What this could lead to
If successful, this could explain why some people get high cholesterol on keto diets, potentially guiding safer diet recommendations.
What could go wrong
This is a small, early-stage observational study focused on understanding mechanisms, not testing a treatment. Results may not apply to everyone or lead to immediate changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 39 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. age ≥ 18 and \< 40 years 2. BMI ≥ 18.5 and \< 25.0 kg/m2 3. baseline serum LDL-c \< 150 mg/dL (\< 3.9 mmol/L) 4. baseline serum TG \< 100 mg/dL (\< 1.1 mmol/L) 5. HbA1c ≤ 5.6%. Exclusion Criteria: 1. personal or family history of familial hypercholesterolemia 2. current use of lipid-lowering drugs 3. currently on a ketogenic diet and unwilling to change diet 4. current tobacco use 5. hypertension 6. prediabetes or diabetes 7. elevated Lp(a) \> 6.5% of ApoB-containing lipoproteins at baseline 8. oral contraceptive use 9. contraindication to heparin 10. known atherosclerotic cardiovascular disease 11. unwilling to abstain from alcohol

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Conditions

The condition(s) this trial relates to.

Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypercholesterolemia and hyperlipidemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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