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Could a High-Fat diet help stabilize the brain in mental illness?

NCT ID NCT05268809

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested whether a very low-carbohydrate ketogenic diet could improve brain network stability and thinking skills in people with schizophrenia or bipolar disorder. The diet is high in fat and low in carbs, which makes the body produce ketones that may provide extra energy to the brain. Seventy-one participants followed either the ketogenic diet or their usual diet for four weeks, and researchers measured changes in brain scans, body composition, inflammation, and insulin resistance.

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 it works, this could point toward a dietary approach to improve cognitive function and brain stability in people with schizophrenia or bipolar disorder.
What could go wrong
This is a small, early-stage study with only 71 participants. The diet is hard to follow long-term, and results may not apply to everyone. It does not replace standard medication.

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

71 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 2025

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 65 years

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: * Male or female ages 18-65 years old * Able to attend 2 in-person visits at the San Francisco VA Medical Center * SCID-5 Schizophrenia or schizoaffective disorder stable on 2nd generation anti-psychotic (SZ) or bipolar disorder (BD) * Not currently on KETO diet * Willing to adhere to 4 wk. KETO diet or 4 wk. non-KETO diet per random assignment * Speak, read, comprehend English * Access to internet * Willing and able to heat up KETO meals Exclusion Criteria: * Current Cancer diagnosis * Other SCID-5 Axis 1 disorder * Pregnancy, breastfeeding, or planned pregnancy * Current diagnosis of type 1 Diabetes Mellitus * Glucose-lowering drugs (other than metformin) or weight loss pills * History of gastric bypass surgery or any weight loss surgery * \>10% weight fluctuation in past 2 years

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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

  • San Francisco VA Medical Center

    San Francisco, California, 94121, United States

More trials for these conditions

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