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

  • End date
    Dec 21, 2021
  • participants needed
  • sponsor
    Stanford University
Updated on 21 February 2021
cardiovascular disease
impaired glucose tolerance
insulin resistance
bipolar disorder
psychiatric disorder
psychotropic drugs
mood stabilizer
mood stabilizers
dietary modification


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.

Condition Weight Gain, Metabolic disorder, Bipolar Disorder, adiposity, Obesity, Metabolic syndrome, Schizophrenia, Schizophrenia and Schizoaffective Disorders, Ketogenic Dieting, Bipolar Disorders (Pediatric), Schizophrenia and Schizoaffective Disorders (Pediatric), Manic Disorders, Metabolic Disorders, Psychotropic Drug, Unspecified Causing Adverse Effects in Therapeutic Use, Psychotropic Drug, Unspecified Causing Adverse Effects in Therapeutic Use, Psychotropic Drug, Unspecified Causing Adverse Effects in Therapeutic Use, schizophrenia disorders, metabolic syndrome x, Psychotropic Drug, Unspecified Causing Adverse Effects in Therapeutic Use, Psychotropic Drug, Unspecified Causing Adverse Effects in Therapeutic Use, Psychotropic Drug, Unspecified Causing Adverse Effects in Therapeutic Use
Treatment LCHF, Ketogenic Diet
Clinical Study IdentifierNCT03935854
SponsorStanford University
Last Modified on21 February 2021


Yes No Not Sure

Inclusion Criteria

Age 18-70 years old
Meet DSM V criteria for schizophrenia or bipolar disorder, any subtype, for > 1 year and clinically stable (with no hospitalization for past 3 months)
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)
Willing to consent to all study procedures and attend follow-up appointments and motivated to follow the dietary program
Sufficient control over their food intake to adhere to study diets
Willingness to regularly monitor blood pressure, glucose, dietary intake, and body weight over the 4-month trial

Exclusion Criteria

Any subject pregnant or nursing
Comorbidity of developmental delay
Active substance abuse with illicit drugs or alcohol
In a current severe mood or psychotic state when entering the study that would prohibit compliance with study visits or dietary program
Anyone who has been hospitalized or taken clozapine over the past 3 months
Inability to complete baseline measurements
Severe renal or hepatic insufficiency
Cardiovascular dysfunction, including diagnosis of
Congestive heart failure
Valvular heart disease
Any other medical condition that may make either diet dangerous as determined by the study medical team (e.g. anorexia nervosa)
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