Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic Diet 16 Week Group | Experimental | Patients follow ketogenic diet for 16 weeks, with monitoring of physical and psychological health and coaching support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCHF, Ketogenic Diet | Other | Low Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Psychiatric Indices - Mood | Change in Mood Qualitative Score (Clinical Mood Monitoring) from baseline | Baseline, 16 weeks |
| Psychiatric Indices- Clinical Global Impression | Change in Clinical Global Impression Scales (CGI) from baseline 1-7 scale. 1= not at all ill, 7= among the most extremely ill patients) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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:
Any other medical condition that may make either diet dangerous as determined by the study medical team (e.g. anorexia nervosa)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shebani Sethi, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Department of Psychiatry & Behavioral Sciences | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32773576 | Background | 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. | |
| 32010444 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 15, 2021 | Nov 21, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Baseline, 16 weeks |
| Generalized Anxiety Disorder - GAD-7 Anxiety | Change in Generalized Anxiety Symptom (GAD-7) scale from baseline. 0-15+ scale. (0= no anxiety, 15+= severe anxiety) | Baseline, 16 weeks |
| Patient Health Questionnaire - PHQ-9 Depression | Change in Patient Health Questionnaire (PHQ-9) from baseline. Score range 0-27 (0= no depression, 27= severe depression) | Baseline, 16 weeks |
| Psychiatric Indices- Global Assessment of Functioning | Change in Global Assessment of Functioning (GAF) Scale from baseline. 1-100 scale (1= persistent danger of hurting self or others, 100= superior functioning) | Baseline, 16 weeks |
| Psychiatric Indices- Quality of Life | Change in Manchester Quality of Life Scale (MANSA) 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) | Baseline, 16 weeks |
| Psychiatric Indices- BPRS | Change in Brief Psychiatric Rating Scale (BPRS) from baseline. Score range 18-126. (For each of 18 symptoms, 1=symptom not present, 7= extremely severe) | Baseline, 16 weeks |
| Pittsburgh Sleep Quality Index - PSQI | Change in Pittsburgh Sleep Quality Index from baseline. 0-21 scale (<5=good sleeper; 5+= meaningfully disturbed sleep or poor sleeper) | Baseline, 16 weeks |
| 32773571 | 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. |
| 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 |
| 30075165 | 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. |
| 31192814 | 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. |
| 38547601 | Result | 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. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D001714 | Bipolar Disorder |
| D012559 | Schizophrenia |
| D015430 | Weight Gain |
| D001928 | Brain Diseases, Metabolic |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001836 | Body Weight Changes |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided