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

NCT ID: NCT03935854

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-13
• Study Completion Date: 2022-08-11

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.

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, along with other psychiatric diseases schizophrenia, 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketogenic Diet 16 Week Group

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

Group Type: EXPERIMENTAL

LCHF, Ketogenic Diet

Intervention Type: OTHER

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

Interventions

LCHF, Ketogenic Diet

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 18-75 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Shebani Sethi

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shebani Sethi, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Department of Psychiatry & Behavioral Sciences

Stanford, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 32773576 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32010444 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32773571 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 30075165 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31192814 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38547601 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

48527

Identifier Type: -

Identifier Source: org_study_id