Trial Search Results

Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Schizophrenia or Bipolar Illness

To initiate a low-carbohydrate, high-fat (LCHF) ketogenic dietary intervention among a small cohort of outpatients with either schizophrenia or bipolar illness and comorbid overweight/obesity currently taking psychotropic medications.

Adults with mental illness represent a high-risk, marginalized group in the current obesity epidemic. Among US adults with severe mental illness, obesity and overweight are highly prevalent conditions having severe consequences, with patients estimated to die on average 25 years earlier than the general population largely of premature cardiovascular disease. In addition, many psychiatric medications, particularly antipsychotics and mood stabilizers, can contribute to metabolic side effects and weight gain. Low-carbohydrate high-fat (LCHF) diets have been shown to reduce cardiovascular risk in those with insulin resistance. The purpose of this study is to evaluate both the metabolic and psychiatric outcomes with an LCHF diet in this psychiatric population.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):


  • Other: LCHF, Ketogenic Diet




Inclusion Criteria:

   1. Age 18-70 years old

   2. Meet DSM V criteria for schizophrenia or bipolar disorder, any subtype, for > 1 year
   and clinically stable (with no hospitalization for past 3 months)

   3. Currently taking psychotropic medication and gained at least 5% weight since starting
   medication or have a BMI greater than or equal to 26 kg/m2 or presence of at least one
   metabolic abnormality (hypertriglyceridemia, insulin resistance, dyslipidemia,
   impaired glucose tolerance)

   4. Willing to consent to all study procedures and attend follow-up appointments and
   motivated to follow the dietary program.

   5. Sufficient control over their food intake to adhere to study diets.

   6. Willingness to regularly monitor blood pressure, glucose, dietary intake, and body
   weight over the 4-month trial

Exclusion Criteria:

   1. Any subject pregnant or nursing

   2. Comorbidity of developmental delay

   3. Active substance abuse with illicit drugs or alcohol

   4. In a current severe mood or psychotic state when entering the study that would
   prohibit compliance with study visits or dietary program.

   5. Anyone who has been hospitalized or taken clozapine over the past 3 months

   6. Inability to complete baseline measurements

   7. Severe renal or hepatic insufficiency

   8. Cardiovascular dysfunction, including diagnosis of:

      1. Congestive heart failure

      2. Angina

      3. Arrhythmias

      4. Cardiomyopathy

      5. Valvular heart disease

   9. Any other medical condition that may make either diet dangerous as determined by the
   study medical team (e.g. anorexia nervosa)

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study


Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kat Nameth Clinical Research Coordinator