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Could a High-Fat diet help heal the brain after injury?

NCT ID NCT04530032

Disease control Sponsor: Loma Linda University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether a ketogenic or modified Atkins diet can help people recover from moderate to severe traumatic brain injury. The diet aims to change how the brain uses energy, potentially improving function. Twenty-one participants were enrolled, and researchers measured changes in disability and brain metabolism over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ketogenic diet (modified Atkins diet)
What this could lead to
If it works, this could point toward a dietary approach to improve recovery after traumatic brain injury.
What could go wrong
This was a very small trial with only 21 people, so results may not apply widely. The diet can be hard to follow and may cause side effects like nutrient imbalances.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

21 people

The number who actually took part.

Started

Dec 2020

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * complicated mild (GCS 13-15), moderate (GCS 9 - 12) to severe (GCS ≤ 8) traumatic brain injury (TBI) between 2-30 days post injury * Admitted to Loma Linda University surgical intensive care unit (SICU) Exclusion Criteria: * history of comorbid ischemic stroke following qualifying TBI * history of premorbid brain injury with associated loss of consciousness * history of psychiatric disorder * history of premorbid neurological disorder or neurosurgical intervention * pregnancy * depressed GCS score due to acute intoxication * liver dysfunction as defined by liver enzymes 5 times the upper limit of normal or chronic cirrhosis * acute renal failure according to the Risk, Injury, Failure, Loss of kidney function, and End-stage kidenty disease (RIFLE) classification * abdominal surgery during the same admission * type 1 diabetes * gastroparesis * dyslipidemia * severe asphasia * known history of metabolic disorders that are a contradiction for ketogenic diet (KD) such as primary carnitine deficient, carnitine palmitoyltransferase (CPT) I or II deficiency, carnitine translocase deficiency, beta-oxidation defects, pyruvate carboxylase deficiency, or porphyria * prealbumin (transthyretin) levels of \<10 mg/dL within 3 days of admission * Metal, implanted device (ICP monitor), pregnancy, claustrophobia, or other contraindication to MRI

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Traumatic brain injury

Contacts and locations

Locations

  • Loma Linda University Health

    Loma Linda, California, 92354, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.