Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling
NCT06748950 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-05-16
Summary
The goal of this randomized clinical trial is to be adequately powered to evaluate the effect of ketogenic metabolic therapy on the quality of life in serious mental illness, schizophrenia, bipolar disorder, major depressive disorder.
Conditions
- Schizophrenia
- Schizophrenia and Related Disorders
- Bipolar Disorder
- Bipolar and Related Disorders
- Major Depressive Disorder
- Major Depression Severe
- Ketogenic Dieting
- Ketosis
- Metabolic Disease
- Metabolic Syndrome
Interventions
- OTHER
-
LCHF Ketogenic Diet
Low Carbohydrate, Moderate Protein, High Fat (LCHF) Ketogenic Dietary Intervention for 12 weeks
- OTHER
-
Diet-as-Usual (DAU)
Participant's usual diet
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Shebani Sethi, MD, ABOM · Stanford University
-
Michael Snyder, PhD · Stanford University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-31
- Primary Completion
- 2028-07-31
- Completion
- 2028-07-31
Countries
- United States
Study Locations
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