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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

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

Clinicaltrials.gov identifier NCT03935854

Recruitment Status Recruiting

First Posted May 2, 2019

Last update posted March 23, 2020

Study Description

Brief summary:

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 or Disease:Obesity
    Ketogenic Dieting
    Metabolic Syndrome
    Bipolar Disorder
    Schizophrenia
    Weight Gain
    Psychotropic Drug, Unspecified Causing Adverse Effects in Therapeutic Use
  • Intervention/Treatment: Other: LCHF, Ketogenic Diet
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Impact of A Low-Carbohydrate, High-Fat, Ketogenic Diet on Obesity, Metabolic Abnormalities and Psychiatric Symptoms in Patients With Schizophrenia or Bipolar Illness: An Open Pilot Trial
  • Actual Study Start Date: February 2019
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Ketogenic Diet 16 Week Group
Other: LCHF, Ketogenic Diet
Low Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 16 weeks
Outcome Measures
  • Primary Outcome Measures: 1. Change in heart rate from baseline [ Time Frame: Baseline, 16 weeks ]
  • 2. Change in blood pressure from baseline [ Time Frame: Baseline, 16 weeks ]
  • 3. Change in weight from baseline [ Time Frame: Baseline, 16 weeks ]
  • 4. Change in body fat mass from baseline [ Time Frame: Baseline, 16 weeks ]
  • 5. Percent Change in Hemoglobin A1c from baseline [ Time Frame: Baseline, 16 weeks ]
  • 6. Change in insulin resistance measure (HOMA-IR) from baseline [ Time Frame: Baseline, 16 weeks ]
  • 7. Change in inflammatory marker (hsCRP) from baseline [ Time Frame: Baseline, 16 weeks ]
  • 8. Change in lipid profile (triglycerides) from baseline [ Time Frame: Baseline, 16 weeks ]
  • 9. Change in lipid profile (small dense LDL) from baseline [ Time Frame: Baseline, 16 weeks ]
  • 10. Change in lipid profile (HDL) from baseline [ Time Frame: Baseline,16 weeks ]
  • Secondary Outcome Measures: 1. Psychiatric Indices - Mood [ Time Frame: Baseline, 16 weeks ]
    Change in Mood Score (Clinical Mood Monitoring) from baseline
  • 2. Psychiatric Indices- Clinical Global Impression [ Time Frame: Baseline, 16 weeks ]
    Change in Clinical Global Impression Scales (CGI) from baseline
  • 3. Psychiatric Indices- Global Assessment of Functioning [ Time Frame: Baseline, 16 weeks ]
    Change in Global Assessment of Functioning (GAF) Scale from baseline
  • 4. Psychiatric Indices- Quality of Life [ Time Frame: Baseline, 16 weeks ]
    Change in Manchester Quality of Life Scale (MANSA) from baseline
  • 5. Psychiatric Indices- BPRS [ Time Frame: Baseline, 16 weeks ]
    Change in Brief Psychiatric Rating Scale (BPRS) from baseline
Eligibility Criteria
  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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)

Contacts and Locations
Contacts

Contact: Shebani Sethi Dalai, MD 650-721-4419 shebanis@stanford.edu

Contact: Kat Nameth, M.S. 650-721-2168 knameth@stanford.edu

Locations

United States, California
Stanford University Department of Psychiatry & Behavioral Sciences
Stanford

Sponsors and Collaborators

Stanford University

Obesity Treatment Foundation

Investigators

Principal Investigator: Shebani Sethi Dalai, MD Stanford University

More Information
  • Responsible Party: Stanford University
  • ClinicalTrials.gov Identifier: NCT03935854 History of Changes
  • Other Study ID Numbers: 48527, OTF005
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: March 23, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Obesity
    Metabolic Syndrome
    Weight Gain
    Schizophrenia
    Bipolar Disorder