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Could a High-Fat diet help fight brain cancer? early trial tests safety

NCT ID NCT03451799

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase study tested whether a 4-month ketogenic diet (a high-fat, low-carb diet) is safe and doable for people with newly diagnosed glioblastoma, a serious brain cancer. Twenty-one adults followed personalized meal plans while receiving standard radiation and chemotherapy. The main goals were to check for side effects like severe weight loss and to see if participants could maintain ketosis (a metabolic state). This trial does not yet prove the diet helps treat the cancer, but it aims to lay the groundwork for future studies.

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 show that a ketogenic diet is safe and feasible alongside standard treatment, potentially pointing toward a way to improve outcomes for glioblastoma patients.
What could go wrong
This is a very early phase 1 trial with only 21 participants, focused on safety and feasibility, not effectiveness. The diet is demanding and may cause weight loss or other side effects, and it is unclear if it will help fight the cancer.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

21 people

The number who actually took part.

Started

Apr 2018

Finished

Apr 2024

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 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Adults (age ≥ 18 years) * Newly or recently diagnosed glioblastoma. Patients may enroll in the study from the time of diagnosis (prior to the initiation of standard-of-care chemoradiation) up until the initiation of post-radiation adjuvant chemotherapy (typically approximately 3-4 weeks after the completion of radiation therapy). Overall, this provides a window of approximately 3 months from the time of diagnosis for patients to enroll in this study. No recurrent glioblastoma is allowed on trial. * Being seen for treatment of glioblastoma at Cedars-Sinai Medical Center. Note: Okay if patients receiving chemotherapy or radiation therapy at another facility * Patients on low and managed doses of steroids are permitted. Up to 8 mg dexamethasone or steroid equivalent. Exclusion Criteria: * Karnofsky Performance Status of \<70 as deemed by physician or equivalent * Body Mass Index of \<22 kg/m2 (rounded to nearest integer) * Patients with disorders that affect lipid metabolism such as pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, Beta-Oxidation Defects * Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study * Pregnant, nursing, or implanted with an intrauterine device (IUD) that is not MR compatible * Patients who are vegan or vegetarian will be excluded, as the ketogenic diet includes foods that may interfere with these preferences * Patients on high doses of steroids will be excluded * Patients currently receiving experimental therapeutic therapy will be excluded from the trial. Note: Off-label therapy use is permitted * Inability to adhere to the protocol * Patients with history of allergic reactions to surgical steel or elastomer/rubber are excluded from the activity monitor portion of the study. Because the activity monitor uses a Bluetooth low energy Transceiver, individuals using pacemakers, implantable cardiac defibrillators, neuro-stimulation devices, cochlear implants, hearing aids, or other electronic medical equipment should also be excluded from wearing the activity monitor. They can still use the Aria scale to record weight. * Patients with mechanically, magnetically, or electrically activated implants, such as cardiac pacemakers, neurostimulators, and infusion pumps, that are not magnetic resonance imaging/positron emission tomography (MRI/PET) compatible. * Patients with ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial, aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged. * Patients unable to tolerate MRI/PET imaging secondary to an inability to lie supine or severe claustrophobia as assessed by the treating physician or principal investigator. * Patients unable to lie still, hold their breath, or follow imaging procedure instructions as assessed by the treating physician or PI. * Patients whose most recent renal function test does not meet Cedars-Sinai Medical center standard of care MRI contrast protocol requirements (glomerular filtration rate \<45ml/min). * Patients with a known allergy to Fludeoxyglucose F18 (F18-FDG) radioactive tracer or gadolinium-based contrast agent. * Patients with allergy to animal dander or animal-instigated asthma.

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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

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

More trials for these conditions

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