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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03935854
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : March 23, 2020
Sponsor:
Collaborator:
Obesity Treatment Foundation
Information provided by (Responsible Party):
Shebani Sethi Dalai, Stanford University

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 Intervention/treatment Phase
Obesity Ketogenic Dieting Metabolic Syndrome Bipolar Disorder Schizophrenia Weight Gain Psychotropic Drug, Unspecified Causing Adverse Effects in Therapeutic Use Other: LCHF, Ketogenic Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
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 13, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ketogenic Diet 16 Week Group Other: LCHF, Ketogenic Diet
Low Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 16 weeks




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935854


Contacts
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Contact: Shebani Sethi Dalai, MD 650-721-4419 shebanis@stanford.edu
Contact: Kat Nameth, M.S. 650-721-2168 knameth@stanford.edu

Locations
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United States, California
Stanford University Department of Psychiatry & Behavioral Sciences Recruiting
Stanford, California, United States, 94305
Contact: Kat Nameth Clinical Research Coordinator    650-721-2168    knameth@stanford.edu   
Sub-Investigator: Farnaz Hooshmand, MD         
Sub-Investigator: Laura Saslow, PhD         
Sponsors and Collaborators
Stanford University
Obesity Treatment Foundation
Investigators
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Principal Investigator: Shebani Sethi Dalai, MD Stanford University
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Responsible Party: Shebani Sethi Dalai, Clinical Instructor, Stanford University
ClinicalTrials.gov Identifier: NCT03935854    
Other Study ID Numbers: 48527
OTF005 ( Other Grant/Funding Number: Obesity Treatment Foundation )
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Metabolic Syndrome
Weight Gain
Schizophrenia
Bipolar Disorder
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Bipolar and Related Disorders
Body Weight Changes