Status:
ACTIVE_NOT_RECRUITING
Can Neural Network Instability in Schizophrenia be Improved With a Very Low Carbohydrate Ketogenic Diet?
Lead Sponsor:
Northern California Institute of Research and Education
Conditions:
Schizophrenia
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Wide ranging cognitive deficits are major drivers of functional decline and poor outcomes in people with schizophrenia (SZ) and bipolar disorder (BD). Medications do not target pathophysiological mech...
Detailed Description
The diagnosis of schizophrenia (SZ) and bipolar disorder (BPD) as traditionally been based on "positive symptoms," such as delusions and hallucinations, and "negative symptoms," such as anhedonia and ...
Eligibility Criteria
Inclusion
- Male or female ages 18-65 years old
- Able to attend 2 in-person visits at the San Francisco VA Medical Center
- SCID-5 Schizophrenia or schizoaffective disorder stable on 2nd generation anti-psychotic (SZ) or bipolar disorder (BD)
- Not currently on KETO diet
- Willing to adhere to 4 wk. KETO diet or 4 wk. non-KETO diet per random assignment
- Speak, read, comprehend English
- Access to internet
- Willing and able to heat up KETO meals
Exclusion
- Current Cancer diagnosis
- Other SCID-5 Axis 1 disorder
- Pregnancy, breastfeeding, or planned pregnancy
- Current diagnosis of type 1 Diabetes Mellitus
- Glucose-lowering drugs (other than metformin) or weight loss pills
- History of gastric bypass surgery or any weight loss surgery
- \>10% weight fluctuation in past 2 years
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05268809
Start Date
April 21 2022
End Date
August 31 2025
Last Update
March 21 2025
Active Locations (1)
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1
San Francisco VA Medical Center
San Francisco, California, United States, 94121