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Could a High-Fat, Low-Carb diet ease schizophrenia?

NCT ID NCT05968638

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a ketogenic diet—low in carbs, high in fat—can reduce symptoms in people with schizophrenia or schizoaffective disorder. Fifty adults will be randomly assigned to either the ketogenic diet or a regular diet for several weeks. Researchers will measure changes in psychiatric symptoms using a standard rating scale.

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 help manage schizophrenia symptoms alongside standard treatments.
What could go wrong
This is a small, early-stage trial with only 50 participants, so results may not apply widely. The diet is hard to stick to and may cause side effects like fatigue or nutrient imbalances.

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 50 people

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

Started

Sep 2023

Expected to finish

Aug 2027

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 64 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: 1. Age 18- 64 years 2. Diagnostic and Statistical Manual (DSM-IV/DSM 5) diagnosis of schizophrenia or schizoaffective disorder 3. Antipsychotic regimen with no dose change in last 14 days 4. Minimum score of 45 on BPRS 5. Body mass index \> 18.5 6. Ability to consent determined by a score of 10 or greater on the Evaluation to Sign Consent. Exclusion Criteria: 1. Pregnant or lactating females 2. Type I diabetes or insulin dependent Type II diabetes 3. Current diagnosis of DSM 5 eating disorder 4. Heart failure 5. corrected QT interval (QTc) prolongation greater than or equal to 500ms 6. Significant kidney disease Indicators for possible acute kidney injury (AKI) or moderate chronic kidney disease (CKD) based on some factors below. Each is not used individually but a clinician will determine based on the following: * Creatinine \> 1.3mg/dL * Glomerular Filtration Rate (GFR) \< 60 mL/min/1.73 m2 * Renal tubular disorders * History of kidney transplantation 7. Significant liver disease. Indicators for possible acute or chronic liver disease. Each is not used individually but a clinician will determine based on the following: * Prolonged International Normalized Ratio (INR) greater than or equal to 1.5, elevated bilirubin and aminotransferases (3x normal upper limit) and/or Complete Blood Count (CBC) abnormalities (thrombocytopenia, anemia) * Physical examination abnormalities (jaundice, icteric sclera, asterixis) * Alcohol use disorder (AUD) based on DSM 5 criteria for moderate AUD * History of liver disease (cirrhosis, Wilson disease, Gilbert disease, chronic hepatitis, autoimmune hepatitis, primary biliary cirrhosis (PBC), primary Sclerosing Cholangitis (PSC) alpha-1 antitrypsin deficiency, hereditary hemochromatosis, Budd-Chiari syndrome) * History of liver transplantation 8. Porphyria 9. Genetic disorders that affect fat metabolism (Gaucher disease, Tay-Sachs disease, medium-chain acyl-CoA dehydrogenase deficiency (MCADD) 10. Carnitine deficiency syndromes (primary carnitine deficiency, carnitine palmitoyltransferase deficiency, carnitine translocase deficiency) 11. Pyruvate kinase deficiency 12. Gastroparesis 13. Refusal to eat intervention diet, food allergies or restrictions that the kitchen cannot accommodate, and/or dietary noncompliance with dietary energy needs

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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

  • Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)

    Catonsville, Maryland, 21228, United States

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