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Ketogenic diet for Schizophrenia

N/A
Recruiting
Research Sponsored by Northern California Institute of Research and Education
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female ages 18-65 years old
Diagnosed with SCID-5 Schizophrenia or schizoaffective disorder stable on 2nd generation anti-psychotic (SZ) or bipolar disorder (BD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (0 weeks) and posttreatment (4 weeks)
Awards & highlights

Study Summary

This trial is studying whether a ketogenic diet can improve cognitive function in people with schizophrenia by improving neural network instability.

Who is the study for?
This trial is for adults aged 18-65 with schizophrenia or schizoaffective disorder stable on second-generation antipsychotics, or bipolar disorder. Participants must speak English, have internet access, and be able to heat up ketogenic meals. They should commit to a 4-week ketogenic diet. Exclusions include current cancer diagnosis, other major psychiatric disorders, pregnancy/breastfeeding, type 1 diabetes, history of weight loss surgery or significant weight changes.Check my eligibility
What is being tested?
The study tests if a very low carbohydrate ketogenic diet can improve cognitive deficits in individuals with schizophrenia or bipolar disorder by stabilizing neural networks. The diet consists of roughly 70% fat, 20% protein, and 10% carbohydrates and aims to shift the brain's energy source from glucose to ketones.See study design
What are the potential side effects?
Potential side effects of a ketogenic diet may include fatigue during initial adjustment ('keto flu'), digestive issues like constipation or diarrhea due to high-fat intake, possible nutrient deficiencies without proper planning and supplementation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder and am stable on medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (0 weeks) and posttreatment (4 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (0 weeks) and posttreatment (4 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in body composition after 4 weeks
Change in insulin resistance after 4 weeks
Change in network stabilization after 4 weeks
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ketogenic DietExperimental Treatment1 Intervention
The ketogenic diet is a normo-caloric diet composed of high-fat (70%), low-carbohydrate (10%), and adequate protein (20%) that induces fasting-like effects and the production of ketone bodies. Metabolic Meals will be delivered to KETO subjects' homes via courier, consisting of 3 meals a day plus snacks, targeting 70% fat, 20% protein, 10% carbohydrates.
Group II: Diet as usualActive Control1 Intervention
The Diet As Usual (DAU) participants will be asked to maintain their current dietary habits and will be discouraged from starting new diets during the 4-week study.

Find a Location

Who is running the clinical trial?

Northern California Institute of Research and EducationLead Sponsor
27 Previous Clinical Trials
9,894 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project accept individuals aged 40 and above?

"Eligible participants for this clinical trial must be aged 18 or above and no older than 65."

Answered by AI

Is participation in this research experiment open to me?

"This medical trial is searching for 70 volunteers, aged 18 to 65 and diagnosed with either schizophrenia or schizoaffective disorder (stable on antipsychotics) or bipolar disorder. The prerequisites are: fluency in English, access to the internet, readiness to follow a KETO diet over 4 weeks as well as willingness and ability to heat up meals accordingly."

Answered by AI

How many participants are enrolled in this research project?

"Affirmative. Clinicaltrials.gov hosts the details of this clinical trial which was initially posted on April 21, 2022 and most recently updated on September 28th that same year. The research requires 70 participants from a single medical centre to be recruited for it's duration."

Answered by AI

Are there opportunities for volunteers to partake in this experiment?

"Affirmative. The information available on clinicaltrials.gov attests to this trial's active recruitment status, which began in April 21st 2022 and was last updated at the end of September that same year. 70 participants are needed from a single location."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
San Francisco VA Medical Center
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I am looking to make life changes to control my symptom and create a new lifestyle.
PatientReceived no prior treatments
Because traditional medication have provided little to no relief and side effects are intolerable 😞.
PatientReceived no prior treatments
After finishing a full psych evaluation recently, I decided I would like to contribute to research related to my mental diagnosis. Learning and contributing to the steady of Bipolar Disorder would help bring me closer to self acceptance.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How often it’s necessary to travel to San Francisco? I work full time, would this interfere with my 8-4:30 weekday schedule?
PatientReceived 2+ prior treatments
~12 spots leftby Aug 2024