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NCT05268809 · ClinicalTrials.gov registry record · NA
Can Neural Network Instability in Schizophrenia be Improved With a Very Low Carbohydrate Ketogenic Diet?
A NA study, sponsored by Northern California Institute of Research and Education.
- Completed
- Registry status
- NA
- Development phase
- 71
- Enrollment target
NCT05268809 is a NA study that has completed, run by Northern California Institute of Research and Education. The registered enrollment target is 71 participants.
The verdict
NCT05268809, a NA study, has completed, sponsored by Northern California Institute of Research and Education.
- COMPLETED
- Registry status
- NA
- Development phase
- 71 participants
- Enrollment target
Study 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 mechanisms thought to underlie these deficits. In the search for interventions targeting underlying cognitive impairment in SZ and BD, we look comprehensively beyond just the brain and to the potential role of dysfunctional systemic metabolism. Disrupted insulin and glucose metabolism are seen in medication-naïve first-episode SZ, suggesting that SZ itself, and not just the medications used to treat it, is associated with risk of Type 2 diabetes, cardiovascular morbidity and mortality, and more generally, accelerated aging. Even young people with SZ have increased risk of metabolic disease and cognitive deficits. Sadly, their life span is shortened by 15-20 years. BD is associated with similar but less severe disruptions in glucose and insulin metabolism and life expectancy. Although the human brain is 2% of the body's volume, it consumes over 20% of its energy, and accordingly, the brain is particularly vulnerable to the dysregulation of glucose metabolism seen in SZ and BD. While glucose is considered to be the brain's default fuel, ketones provide 27% more free energy and are a major source of energy for the brain. Ketones prevent or improve various age-associated diseases, and a ketogenic diet (70% fat, 20% protein, 10% carbohydrates) has been posited as an anti-aging and dementia antidote. The premise of the work is based on recent evidence that ketogenic diets improve dynamic neural network instability, related to cognitive deficits, aging, and Type 2 diabetes (Mujica-Parodi et al., Proc Natl Acad Sci U S A. 2020;117(11):6170-7.). The rigor of the work rests on findings of (1) poor cerebral glucose homeostasis in SZ and BD, (2) neural network instability in SZ and BD, and (3) direct effects of ketosis on network instability. Unknown is whether ketogenic diets can i
Interventions
- OTHER Ketogenic diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2022-04-21 |
| Est. Completion | 2025-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05268809
The ClinicalTrials.gov registry entry for NCT05268809 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northern California Institute of Research and Education, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ketogenic diet is the first listed.
NCT05268809 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05268809 about?
NCT05268809 is a clinical study titled "Can Neural Network Instability in Schizophrenia be Improved With a Very Low Carbohydrate Ketogenic Diet?". 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 mechanisms thought to underlie these deficits. In the search for interventions targeting underlying cogn...
What is the current status of trial NCT05268809?
This trial is currently completed. It is a NA study. The enrollment target is 71 participants. The study started on 2022-04-21. Estimated completion is 2025-08-31.
What interventions are being tested in trial NCT05268809?
The interventions under investigation include: Ketogenic diet (OTHER).
Who is sponsoring clinical trial NCT05268809?
This trial is sponsored by Northern California Institute of Research and Education, which has 6 total clinical trials registered on ClinicalTrials.gov.
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