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

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ClinicalTrials.gov Identifier: NCT03935854
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : December 6, 2021
Sponsor:
Information provided by (Responsible Party):
Shebani Sethi Dalai, Stanford University

Tracking Information
First Submitted Date  ICMJE April 30, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date December 6, 2021
Actual Study Start Date  ICMJE February 13, 2019
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2021)
  • Change in heart rate from baseline [ Time Frame: Baseline, 16 weeks ]
    Heart rate recorded at 9 visits during study
  • Change in blood pressure from baseline [ Time Frame: Baseline, 16 weeks ]
    Blood pressure recorded at 9 visits during study
  • Change in weight from baseline [ Time Frame: Baseline, 16 weeks ]
    Weight recorded at 9 visits during study
  • Change in body fat mass from baseline [ Time Frame: Baseline, 16 weeks ]
    Body composition (SECA) recorded at 5 visits during study
  • Percent Change in Hemoglobin A1c from baseline [ Time Frame: Baseline, 16 weeks ]
    Hemoglobin A1c recorded at initial and final visits
  • Change in insulin resistance measure (HOMA-IR) from baseline [ Time Frame: Baseline, 16 weeks ]
    HOMA-IR measured at initial and final visits
  • Change in inflammatory marker (hsCRP) from baseline [ Time Frame: Baseline, 16 weeks ]
    hsCRP measured at initial and final visits
  • Change in lipid profile TG (triglycerides) from baseline [ Time Frame: Baseline, 16 weeks ]
    Lipid profile TG measured at initial and final visits
  • Change in lipid profile small LDL (small dense LDL) from baseline [ Time Frame: Baseline, 16 weeks ]
    Lipid profile small LDL measured at initial and final visits
  • Change in lipid profile (HDL) from baseline [ Time Frame: Baseline,16 weeks ]
    Lipid profile HDL measured at initial and final visits
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Change in heart rate from baseline [ Time Frame: Baseline, 16 weeks ]
  • Change in blood pressure from baseline [ Time Frame: Baseline, 16 weeks ]
  • Change in weight from baseline [ Time Frame: Baseline, 16 weeks ]
  • Change in body fat mass from baseline [ Time Frame: Baseline, 16 weeks ]
  • Percent Change in Hemoglobin A1c from baseline [ Time Frame: Baseline, 16 weeks ]
  • Change in insulin resistance measure (HOMA-IR) from baseline [ Time Frame: Baseline, 16 weeks ]
  • Change in inflammatory marker (hsCRP) from baseline [ Time Frame: Baseline, 16 weeks ]
  • Change in lipid profile (triglycerides) from baseline [ Time Frame: Baseline, 16 weeks ]
  • Change in lipid profile (small dense LDL) from baseline [ Time Frame: Baseline, 16 weeks ]
  • Change in lipid profile (HDL) from baseline [ Time Frame: Baseline,16 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Psychiatric Indices - Mood [ Time Frame: Baseline, 16 weeks ]
    Change in Mood Score (Clinical Mood Monitoring) from baseline
  • Psychiatric Indices- Clinical Global Impression [ Time Frame: Baseline, 16 weeks ]
    Change in Clinical Global Impression Scales (CGI) from baseline
  • Psychiatric Indices- Global Assessment of Functioning [ Time Frame: Baseline, 16 weeks ]
    Change in Global Assessment of Functioning (GAF) Scale from baseline
  • Psychiatric Indices- Quality of Life [ Time Frame: Baseline, 16 weeks ]
    Change in Manchester Quality of Life Scale (MANSA) from baseline
  • Psychiatric Indices- BPRS [ Time Frame: Baseline, 16 weeks ]
    Change in Brief Psychiatric Rating Scale (BPRS) from baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Schizophrenia or Bipolar Illness
Official Title  ICMJE 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
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 who also are overweight/obese, with metabolic disorders, and/or are currently taking psychotropic medications.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Ketogenic Dieting
  • Metabolic Syndrome
  • Bipolar Disorder
  • Schizophrenia
  • Weight Gain
  • Psychotropic Agents Causing Adverse Effects in Therapeutic Use
Intervention  ICMJE Other: LCHF, Ketogenic Diet
Low Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 16 weeks
Study Arms  ICMJE Experimental: Ketogenic Diet 16 Week Group
Patients follow ketogenic diet for 16 weeks, with monitoring of physical and psychological health and coaching support
Intervention: Other: LCHF, Ketogenic Diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 30, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shebani Sethi Dalai, MD 650-721-4419 shebanis@stanford.edu
Contact: Diane E Wakeham, Ph.D. wakeham@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03935854
Other Study ID Numbers  ICMJE 48527
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shebani Sethi Dalai, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shebani Sethi Dalai, MD Stanford University
PRS Account Stanford University
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP