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Keto diet may raise 'Bad' cholesterol differently depending on your weight

NCT ID NCT06515912

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study from Penn State University looked at how a strict 4-week ketogenic diet (very low carb, high fat) affects blood cholesterol and heart health in 25 healthy adults. Researchers compared people with a healthy BMI to those with obesity to see if the diet raises 'bad' LDL cholesterol more in one group. Participants ate only study-provided meals and had fasting blood tests and vascular function measurements before and after the diet.

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 (5% carbs, 18% protein, 77% fat)
What this could lead to
If successful, this could help clarify how the ketogenic diet affects heart disease risk differently in people with healthy weight versus obesity.
What could go wrong
This is a small, short-term study (25 people, 4 weeks) that only measures changes in blood lipids and vascular function, not actual heart disease outcomes. Results may not apply to the general population.

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

25 people

The number who actually took part.

Started

Jan 2025

Finished

Mar 2026

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

25 to 45 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 25-45 years 2. Fasting direct LDL-C ≤100 mg/dL 3. BMI of 18.5-22 kg/m2 or 30-35 kg/m2 4. Blood pressure \<140/90 mmHg 5. Fasting blood glucose \<126 mg/dL 6. Fasting triglycerides \<350 mg/dL 7. ≤10% change in body weight for 6 months prior to enrollment Exclusion Criteria: 1. Have type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL 2. Prescription of anti-hypertensive, lipid-lowering or glucose-lowering drugs 3. Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period 4. Diagnosed liver, kidney, or autoimmune disease 5. Prior cardiovascular event (e.g., stroke, heart attack) 6. Current pregnancy or intention of pregnancy within the next 2 months 7. Lactation within prior 6 months 8. Follows a vegetarian or vegan diet 9. Food allergies/intolerance/sensitives/dislikes of foods included in the study menu 10. Antibiotic use within the prior 1 month 11. Oral steroid use within the prior 1 month 12. Use of tobacco or nicotine containing products within the past 6 months 13. Cancer at any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence) 14. Participation in another clinical trial within 30 days of baseline 15. Currently following a restricted or weight loss diet 16. Previously consumed the ketogenic diet for more than 1 week 17. Prior bariatric surgery 18. Intake of \>14 alcoholic drinks/week and/or lack of willingness to consume no alcohol while enrolled in the study and/or not willing to avoid alcohol consumption for 48 hours prior to test visits 19. Current or past eating disorder 20. Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements including being able to come to the metabolic kitchen to pick-up food five days per week 21. Planning to relocate out of the State College area in the next 2 months 22. Unwilling to refrain from plasma/blood donations during the study 23. Previously diagnosed familial hypercholesterolemia 24. If a potential participant takes thyroid medicine, abnormal thyroid stimulating hormone (TSH) concentration (TSH outside of normal range of 0.5 - 4.5 mIU/L)

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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.

Contacts and locations

Locations

  • Penn State University

    University Park, Pennsylvania, 16802, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.