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

Not Recruiting

Trial ID: NCT03935854


To initiate a low-carbohydrate, high-fat (LCHF) or ketogenic dietary (KD) intervention among a cohort of outpatients with either schizophrenia or bipolar illness who also have metabolic abnormalities, overweight/obesity, and/or are currently taking psychotropic medications experiencing metabolic side effects.

Official Title

Impact of A Low-Carbohydrate, High-Fat, Ketogenic Diet on Obesity, Metabolic Abnormalities and Psychiatric Symptoms in Patients With Bipolar or Schizophrenia Illness: A Pilot Trial

Stanford Investigator(s)

Shebani Sethi MD, ABOM

Clinical Associate Professor, Psychiatry and Behavioral Sciences


Inclusion Criteria:

   1. Age 18-75 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)


other: LCHF, Ketogenic Diet

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Diane E Wakeham, CRC, PhD