Keto diet cholesterol mystery: scientists investigate
NCT ID NCT06894004
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
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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
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 39 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Washington University School of Medicine
RECRUITINGSt Louis, Missouri, 63110, United States
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