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NCT04530032 · ClinicalTrials.gov registry record · NA
Ketogenic Diet & Functional Recovery in Moderate to Severe Traumatic Brain Injury
A NA study, sponsored by Loma Linda University.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT04530032: Completed NA study, sponsored by Loma Linda University.
NCT04530032 is a NA study that has completed, run by Loma Linda University. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04530032, a NA study, has completed, sponsored by Loma Linda University.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
Traumatic Brain Injury (TBI) represents a significant public health risk in the United States leaving many survivors with significant long term cognitive deficits and at risk for neurodegenerative diseases. Despite extensive research there are no pharmacological therapies which have demonstrated significant improvement in neurological or cognitive recovery. Changes in glucose metabolism are considered the hallmark metabolic response to TBI and ketosis has been proposed as a therapy to ameliorate metabolic dysfunction. This trial investigates the therapeutic potential of a ketogenic or modified Atkins diet on neurocognitive outcome following moderate-severe TBI.
Primary Outcome
The Disability Rating Scale (DRS) will be used to measure general functional changes as a result of the dietary intervention over a 6 month recovery period. This scale ranges from 0 (without disability) to a maximum score of 29 (extreme vegetative state).
Interventions
- OTHER ketogenic/modified Atkins diet
- OTHER Standard diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-12-07 |
| Est. Completion | 2025-08-14 |
| Phase | NA |
What the finished NCT04530032 record still lists
NCT04530032 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which ketogenic/modified Atkins diet is the first listed.
NCT04530032 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04530032 about?
NCT04530032 is a clinical study titled "Ketogenic Diet & Functional Recovery in Moderate to Severe Traumatic Brain Injury". Traumatic Brain Injury (TBI) represents a significant public health risk in the United States leaving many survivors with significant long term cognitive deficits and at risk for neurodegenerative diseases. Despite extensive research there are no pharmacological therapies which have demonstrated sig...
What is the current status of trial NCT04530032?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2020-12-07. Estimated completion is 2025-08-14.
What interventions are being tested in trial NCT04530032?
The interventions under investigation include: ketogenic/modified Atkins diet (OTHER), Standard diet (OTHER).
Who is sponsoring clinical trial NCT04530032?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04530032's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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