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

Trial ID or NCT#

NCT03935854

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Age 18-75 years old2. 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. 1. Any subject pregnant or nursing2. Comorbidity of developmental delay3. Active substance abuse with illicit drugs or alcohol4. 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 months6. Inability to complete baseline measurements7. Severe renal or hepatic insufficiency8. Cardiovascular dysfunction, including diagnosis of:
  2. 1. Congestive heart failure 2. Angina 3. Arrhythmias 4. Cardiomyopathy 5. Valvular heart disease9. 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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Investigator(s)

Shebani Sethi MD, ABOM
Clinical Associate Professor, Psychiatry and Behavioral Sciences

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Contact

Diane E Wakeham, CRC, PhD

View on ClinicalTrials.gov