Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06748950
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • LCHF Ketogenic Diet — OTHER
    Low Carbohydrate, Moderate Protein, High Fat (LCHF) Ketogenic Dietary Intervention for 12 weeks
  • Diet-as-Usual (DAU) — OTHER
    Participant's usual diet

Study Details

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.

Key Dates

Start date
Jul 31, 2025
Status verified
May 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Ketogenic Diet Only
    Participants will follow 12 weeks of the ketogenic diet, with monitoring of physical and psychological health and coaching support.
  • Experimental: Arm 2: DAU- Ketogenic Diet Crossover
    Participants will follow 12 weeks of their usual diet (Diet-as-Usual, DAU). Then, participants will crossover and follow 12 weeks of the ketogenic diet. Monitoring of physical and psychological health and coaching support will occur throughout participation.

Primary Outcome Measure

WHO-5 Well-being Index [ Time Frame: Baseline through study completion, an average of 12 weeks (Arm 1: Ketogenic Diet Only) or 24 weeks (Arm 2: DAU-Ketogenic Diet Crossover). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Study Coordinators
[email protected]
650-725-0169

Find similar trials in Palo Alto, CA

By condition
Bipolar disorderDepressionSchizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Stanford University· Palo Alto, CA

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