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

NCT03935854 | Completed

• 1 other identifier: 48527
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Ketogenic Dieting; Metabolic Syndrome; Bipolar Disorder; Schizophrenia; Weight Gain; Psychotropic Agents Causing Adverse Effects in Therapeutic Use; Brain Metabolic Disorder

Outcome Measures

Primary Outcomes (12)

• Change in heart rate from baseline

  Heart rate recorded at 9 visits during study

  Baseline, 16 weeks

• Change in blood pressure from baseline

  Blood pressure recorded at 9 visits during study

  Baseline, 16 weeks

• Change in weight from baseline

  Weight recorded at 9 visits during study

  Baseline, 16 weeks

• Change in waist circumference from baseline

  waist circumference measured at 9 visits during study

  Baseline, 16 weeks

• Change in visceral fat mass from baseline

  Body composition (SECA) recorded at 5 visits during study

  Baseline, 16 weeks

• Change in body fat mass from baseline

  Body composition (SECA) recorded at 5 visits during study

  Baseline, 16 weeks

• Percent Change in Hemoglobin A1c from baseline

  Hemoglobin A1c recorded at initial and final visits

  Baseline, 16 weeks

• Change in insulin resistance measure (HOMA-IR) from baseline

  HOMA-IR measured at initial and final visits

  Baseline, 16 weeks

• Change in inflammatory marker (hsCRP) from baseline

  hsCRP measured at initial and final visits

  Baseline, 16 weeks

• Change in lipid profile TG (triglycerides) from baseline

  Lipid profile TG measured at initial and final visits

  Baseline, 16 weeks

• Change in lipid profile small LDL (small dense LDL) from baseline

  Lipid profile small LDL measured at initial and final visits

  Baseline, 16 weeks

• Change in lipid profile (HDL) from baseline

  Lipid profile HDL measured at initial and final visits

  Baseline,16 weeks

Secondary Outcomes (8)

• Psychiatric Indices - Mood

  Baseline, 16 weeks

• Psychiatric Indices- Clinical Global Impression

  Baseline, 16 weeks

• Generalized Anxiety Disorder - GAD-7 Anxiety

  Baseline, 16 weeks

• Patient Health Questionnaire - PHQ-9 Depression

  Baseline, 16 weeks

• Psychiatric Indices- Global Assessment of Functioning

  Baseline, 16 weeks

Study Arms (1)

Ketogenic Diet 16 Week Group

EXPERIMENTAL

Patients follow ketogenic diet for 16 weeks, with monitoring of physical and psychological health and coaching support

Other: LCHF, Ketogenic Diet

Interventions

LCHF, Ketogenic Diet OTHER

Low Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 16 weeks

Ketogenic Diet 16 Week Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old
• Meet DSM V criteria for schizophrenia or bipolar disorder, any subtype, for \> 1 year and clinically stable (with no hospitalization for past 3 months)
• 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)
• Willing to consent to all study procedures and attend follow-up appointments and motivated to follow the dietary program.
• Sufficient control over their food intake to adhere to study diets.
• Willingness to regularly monitor blood pressure, glucose, dietary intake, and body weight over the 4-month trial

You may not qualify if:

• Any subject pregnant or nursing
• Comorbidity of developmental delay
• Active substance abuse with illicit drugs or alcohol
• In a current severe mood or psychotic state when entering the study that would prohibit compliance with study visits or dietary program.
• Anyone who has been hospitalized or taken clozapine over the past 3 months
• Inability to complete baseline measurements
• Severe renal or hepatic insufficiency
• Cardiovascular dysfunction, including diagnosis of:
• Congestive heart failure
• Angina
• Arrhythmias
• Cardiomyopathy
• Valvular heart disease
• Any other medical condition that may make either diet dangerous as determined by the study medical team (e.g. anorexia nervosa)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Department of Psychiatry & Behavioral Sciences

Stanford, California, 94305, United States

Location

Related Publications (7)

• Sethi S, Sinha A, Gearhardt AN. Low carbohydrate ketogenic therapy as a metabolic treatment for binge eating and ultraprocessed food addiction. Curr Opin Endocrinol Diabetes Obes. 2020 Oct;27(5):275-282. doi: 10.1097/MED.0000000000000571.

  PMID: 32773576 BACKGROUND

• Carmen M, Safer DL, Saslow LR, Kalayjian T, Mason AE, Westman EC, Sethi S. Treating binge eating and food addiction symptoms with low-carbohydrate Ketogenic diets: a case series. J Eat Disord. 2020 Jan 29;8:2. doi: 10.1186/s40337-020-0278-7. eCollection 2020.

  PMID: 32010444 BACKGROUND

• Norwitz NG, Sethi S, Palmer CM. Ketogenic diet as a metabolic treatment for mental illness. Curr Opin Endocrinol Diabetes Obes. 2020 Oct;27(5):269-274. doi: 10.1097/MED.0000000000000564.

  PMID: 32773571 BACKGROUND

• Yu B, Ozveren R, Sethi Dalai S. Ketogenic diet as a metabolic therapy for bipolar disorder: Clinical developments. Submitted to Journal of Affective Disorders. Research Square preprint March 2020: DOI is: 10.21203/rs.3.rs-334453/v1

  BACKGROUND

• Brietzke E, Mansur RB, Subramaniapillai M, Balanza-Martinez V, Vinberg M, Gonzalez-Pinto A, Rosenblat JD, Ho R, McIntyre RS. Ketogenic diet as a metabolic therapy for mood disorders: Evidence and developments. Neurosci Biobehav Rev. 2018 Nov;94:11-16. doi: 10.1016/j.neubiorev.2018.07.020. Epub 2018 Jul 31.

  PMID: 30075165 BACKGROUND

• Sarnyai Z, Kraeuter AK, Palmer CM. Ketogenic diet for schizophrenia: clinical implication. Curr Opin Psychiatry. 2019 Sep;32(5):394-401. doi: 10.1097/YCO.0000000000000535.

  PMID: 31192814 BACKGROUND

• Sethi S, Wakeham D, Ketter T, Hooshmand F, Bjornstad J, Richards B, Westman E, Krauss RM, Saslow L. Ketogenic Diet Intervention on Metabolic and Psychiatric Health in Bipolar and Schizophrenia: A Pilot Trial. Psychiatry Res. 2024 May;335:115866. doi: 10.1016/j.psychres.2024.115866. Epub 2024 Mar 20.

  PMID: 38547601 RESULT

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Bipolar Disorder; Schizophrenia; Weight Gain; Brain Diseases, Metabolic

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Body Weight Changes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Shebani Sethi, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 2, 2019
• Study Start: February 13, 2019
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)