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

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ClinicalTrials.gov Identifier: NCT05705063
Recruitment Status : Not yet recruiting
First Posted : January 30, 2023
Last Update Posted : January 30, 2023
Sponsor:
Information provided by (Responsible Party):
Shebani Sethi, Stanford University

Study Description
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Brief Summary:
To initiate a low-carbohydrate, high-fat (LCHF) or ketogenic dietary (KD) intervention among a cohort of outpatients with bipolar illness who also have metabolic abnormalities, overweight/obesity, and/or are currently taking psychotropic medications experiencing metabolic side effects.

Condition or disease Intervention/treatment Phase
Bipolar Disorder I Bipolar II Disorder Bipolar I Disorder Bipolar Disorder Bipolar Depression Bipolar and Related Disorders Bipolar Disorder, Type 1 Bipolar Disorder, Type 2 Bipolar Disorder, Mixed Obesity Metabolic Syndrome Ketogenic Dieting Weight Gain Brain Metabolic Disorder Psychotropic Agents Causing Adverse Effects in Therapeutic Use Other: LCHF Ketogenic Diet Not Applicable

Detailed Description:
Adults with mental illness represent a high-risk, marginalized group in the current metabolic and obesity epidemic. Among US adults with severe mental illness, metabolic syndrome 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. Many psychiatric medications, particularly neuroleptics and mood stabilizers, may, in addition, contribute to metabolic side effects and weight gain. Low-carbohydrate high-fat (LCHF) or ketogenic diets (KD) have been shown to reduce cardiovascular risk in those with insulin resistance. Recent findings support the idea that bipolar disorder may have roots of metabolic dysfunction: cerebral glucose hypometabolism, oxidative stress, as well as mitochondrial and neurotransmitter dysfunction which has downstream effects on synapse connections. A KD diet provides alternative fuel to the brain aside from glucose and is believed to contain beneficial neuroprotective effects, including stabilization of brain networks, reduction of inflammation and oxidative stress. The purpose of this study is to evaluate both the metabolic and psychiatric outcomes with a KD diet in this psychiatric population.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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 on Patients With Bipolar Disorder (BPD)
Estimated Study Start Date : January 30, 2023
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bipolar Patients
Patients follow ketogenic diet for 16 weeks, with monitoring of physical and psychological health and coaching support
 Other: LCHF Ketogenic Diet
Low Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 6 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change in Weight from Baseline [ Time Frame: Baseline, 6 weeks ]
    Weight recorded weekly during study

  2. Change in Waist Circumference from Baseline [ Time Frame: Baseline, 6 weeks ]
    Waist circumference recorded at each visit during study

  3. Change in Heart Rate from Baseline [ Time Frame: Baseline, 6 weeks ]
    Heart rate recorded at each visit during study

  4. Change in Blood Pressure from Baseline [ Time Frame: Baseline, 6 weeks ]
    Blood pressure recorded weekly during study

  5. Change in Visceral Fat Mass from Baseline [ Time Frame: Baseline, 6 weeks ]
    Kg visceral fat in body composition (SECA or Inbody) recorded 2-3 times during study

  6. Change in Body Fat Mass from Baseline [ Time Frame: Baseline, 6 weeks ]
    Kg body fat in body composition (SECA or Inbody) recorded 2-3 times during study

  7. Change in Hemoglobin A1c from Baseline [ Time Frame: Baseline, 6 weeks ]
    Blood measurement of Hemoglobin A1c recorded at baseline and study end

  8. Change in Insulin Resistance Measure (HOMA-IR) from Baseline [ Time Frame: Baseline, 6 weeks ]
    HOMA-IR calculated from blood measurements recorded at baseline and study end

  9. Change in Inflammatory Marker (hs-CRP) from Baseline [ Time Frame: Baseline, 6 weeks ]
    Blood measurement of hs-CRP recorded at baseline and study end

  10. Change in Lipid Profile (TG) from Baseline [ Time Frame: Baseline, 6 weeks ]
    Blood levels of Lipid Triglycerides (TG) recorded at baseline and study end

  11. Change in Lipid Profile small LDL from Baseline [ Time Frame: Baseline, 6 weeks ]
    Blood levels of small, low density lipoprotein cholesterol (LDL-C) recorded at baseline and study end

  12. Change in Lipid Profile HDL from Baseline [ Time Frame: Baseline, 6 weeks ]
    Blood levels of high density lipoprotein cholesterol (HDL-C) recorded at baseline and study end


Secondary Outcome Measures :
  1. Change in Clinical Mood Monitoring from Baseline [ Time Frame: Baseline, 6 weeks ]
    Change in Clinical Mood Monitoring Psychiatric Index from Baseline

  2. Change in Clinical Global Impression from Baseline [ Time Frame: Baseline, 6 weeks ]
    Change in Clinical Global Impression (CGI) Psychiatric Index from Baseline; 1-7 scale. (1= not at all ill, 7= among the most extremely ill patients)

  3. Change Generalized Anxiety Disorder from Baseline [ Time Frame: Baseline, 6 weeks ]
    Change in General Anxiety Disorder (GAD-7) scale from Baseline. 0-15+ scale. (0= no anxiety, 15+= severe anxiety)

  4. Change in Depression from Baseline [ Time Frame: Baseline, 6 weeks ]
    Change in Depression on Patient Health Questionnaire (PHQ-9) scale from Baseline; Score range 0-27 (0= no depression, 27= severe depression)

  5. Change in Global Assessment of Functioning from Baseline [ Time Frame: Baseline, 6 weeks ]
    Change in Global Assessment of Functioning (GAF) scale from baseline; 1-100 scale (1= persistent danger of hurting self or others, 100= superior functioning)

  6. Change in Quality of Life from Baseline [ Time Frame: Baseline, 6 weeks ]
    Change in Manchester Quality of Life (MANSA) scale from baseline; Range 12-84 (each of 12 outcomes rated from 1= could not be worse to 7= could not be better; <4= dissatisfied with QoL, >4= satisfied with QoL)

  7. Change in Quality of Sleep from Baseline [ Time Frame: Baseline, 6 weeks ]
    Change in Pittsburgh Sleep Quality Index (PSQI) from baseline; 0-21 scale (<5=good sleeper; 5+= meaningfully disturbed sleep or poor sleeper)

  8. Change in Eating Behavior from Baseline [ Time Frame: Baseline, 6 weeks ]
    Change in Binge Eating Scale (BES) from Baseline; 0-46 scale (<17 minimal binge eating problems, >27 severe binge eating problems)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18 to 75 years of age.
  2. Able to provide informed consent.
  3. Meet DSM V criteria for diagnosis with Bipolar Disorder (BPD), any subtype, for > 1 year and clinically stable (with no hospitalization for past 3 months)
  4. Participants may currently be on a stable and adequate dose of SSRI antidepressant therapy or other psychiatric medications. Concurrent hypnotic therapy (e.g., with zolpidem, zaleplon, melatonin, or trazodone) will be allowed if the therapy has been stable for at least 4 weeks prior to screening and if it is expected to remain stable. Participants may choose to not be on antidepressant therapy for the study duration, or to be switched from other classes to a medication from the SSRI class.
  5. currently taking SSRI or 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)
  6. In good general health, as ascertained by medical history.
  7. If female, a status of non-childbearing potential or use of an acceptable form of birth control. The form of birth control will be documented at screening and baseline.
  8. willing to consent to all study procedures and attend follow-up appointments and motivated to follow dietary program.
  9. Sufficient control over their food intake to adhere to study diets.
  10. willingness to regularly monitor blood pressure, glucose, dietary intake, and body weight over 6-week trial

Exclusion Criteria:

  1. Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
  2. Female that is pregnant or breastfeeding.
  3. Female with a positive pregnancy test at participation.
  4. comorbidity of developmental delay or Cognitive impairment (as noted by previous diagnoses-including dementia).
  5. Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine dependence, at screening or within six months prior to screening.
  6. History of positive screening urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates.
  7. Current (or chronic) use of opiates.
  8. in a current severe mood or psychotic state when entering the study that would prohibit compliance with study visits or dietary program.
  9. Considered at significant risk for suicide during the course of the study.
  10. any one who has been hospitalized or taken clozapine at doses above 550mg over the past 3 months
  11. Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results.
  12. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
  13. Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation.
  14. inability to complete baseline measurements
  15. severe renal or hepatic insufficiency

  16. cardiovascular dysfunction, including diagnosis of:

    1. Congestive heart failure
    2. Angina
    3. Arrhythmias
    4. Cardiomyopathy
    5. Valvular heart disease
    6. History of cardiovascular disease or cardiac event.
  17. any other medical condition that may make either diet dangerous as determined by the study medical team (e.g. anorexia nervosa)
Contacts and Locations
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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): NCT05705063


Contacts
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Contact: Diane E Wakeham, PhD 650-736-5243 wakeham@stanford.edu
Contact: Shebani Sethi, MD 650-721-4419 shebanis@stanford.edu

Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94704
Contact: Diane E Wakeham, PhD    650-736-5243    wakeham@stanford.edu   
Contact: Study Coordinator    650-736-5243      
Principal Investigator: Shebani Sethi, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Shebani Sethi, MD Stanford University Dept Psychiatry and Behavioral Sciences
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Shebani Sethi, CLINICAL ASSISTANT PROFESSOR OF PSYCHIATRY AND BEHAVIORAL SCIENCES, Stanford University
ClinicalTrials.gov Identifier: NCT05705063    
Other Study ID Numbers: 68493
First Posted: January 30, 2023    Key Record Dates
Last Update Posted: January 30, 2023
Last Verified: January 2023
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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Brain Diseases, Metabolic
Obesity
Metabolic Syndrome
Metabolic Diseases
Weight Gain
Bipolar Disorder
Bipolar and Related Disorders
Overweight
Overnutrition
Nutrition Disorders
 Body Weight
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Mood Disorders
Mental Disorders
Body Weight Changes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases