30 Participants Needed

Ketogenic Diet for Traumatic Brain Injury

Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Loma Linda University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a ketogenic diet (a high-fat, low-carb diet) can improve brain function after a traumatic brain injury (TBI). People with moderate to severe TBI often face long-term challenges with thinking and memory, and no proven medicine currently addresses this. The trial compares two groups: one follows a ketogenic or modified Atkins diet, and the other follows a regular diet. It is open to individuals who have recently suffered a TBI and are receiving treatment at Loma Linda University's surgical intensive care unit. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new dietary interventions for TBI recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the ketogenic or modified Atkins diet is safe for individuals with traumatic brain injury?

Research has shown that the ketogenic diet, high in fats and low in carbohydrates, might benefit people with traumatic brain injury (TBI). Early results suggest that adults generally tolerate this diet well.

In one study involving adults with TBI, participants followed a ketogenic diet without major safety concerns. Some individuals might experience fatigue or headaches when starting the diet, but these effects typically subside as the body adjusts.

Overall, evidence suggests that adults with TBI can safely follow the ketogenic diet, although individual experiences may vary.12345

Why are researchers excited about this trial?

The ketogenic diet is unique because it shifts the body's metabolism from burning carbohydrates to burning fats, producing compounds called ketones. Researchers are excited about this approach for traumatic brain injury (TBI) because ketones might provide a more efficient energy source for the brain, potentially improving recovery. Unlike standard treatments that focus on managing symptoms or preventing further brain damage, the ketogenic diet targets the brain's energy supply directly, offering a novel way to support healing.

What evidence suggests that a ketogenic diet might be an effective treatment for traumatic brain injury?

This trial will compare the effects of different diets on recovery from traumatic brain injury (TBI). Participants in one arm of the trial will follow a ketogenic/modified Atkins diet, which is high in fat and low in carbohydrates. Studies have shown that this diet may aid recovery by altering the body's energy source, leading to ketone production, which may help the brain heal. Research suggests that ketosis, where the body uses fat for energy instead of carbohydrates, could address energy issues in the brain after a TBI. Some early studies indicate that this diet might protect the brain and enhance thinking and memory. While more research is needed, the ketogenic diet shows promise in aiding TBI recovery. Participants in another arm will follow a standard diet for comparison.12346

Who Is on the Research Team?

DT

Duc Tran, MD

Principal Investigator

Loma LInda University Medical Center

BB

Brenda Bartnik-Olson, PhD

Principal Investigator

Loma LInda University Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with moderate to severe traumatic brain injury (TBI) admitted to Loma Linda University's surgical intensive care unit. Eligible participants are those within 2-30 days post-injury but not pregnant, without severe speech issues, significant prior neurological disorders or interventions, acute intoxication at the time of injury, certain metabolic disorders that conflict with a ketogenic diet, history of serious mental illness, renal failure, abdominal surgery during admission, Type 1 diabetes or liver dysfunction.

Inclusion Criteria

Admitted to Loma Linda University surgical intensive care unit (SICU)
You have had a serious head injury within the past month.

Exclusion Criteria

Pregnancy
You have severe difficulty speaking or understanding language.
Your prealbumin levels are very low when you are admitted to the study.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a ketogenic or modified Atkins diet to assess its impact on neurocognitive and neurological outcomes

6 months
Regular visits for dietary monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of cognitive and neurological outcomes

6 months
Periodic assessments using MR spectroscopy and neuropsychological tests

What Are the Treatments Tested in This Trial?

Interventions

  • Ketogenic Diet
  • Ketogenic/Modified Atkins Diet
  • Standard Diet
Trial Overview The study explores whether a ketogenic or modified Atkins diet can improve cognitive outcomes after a TBI compared to a standard diet. It aims to address changes in glucose metabolism seen in TBI patients by testing if these diets could help recover brain function.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TBI KD/MADExperimental Treatment1 Intervention
Group II: TBI SDPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials
322
Recruited
267,000+

Published Research Related to This Trial

A pilot study involving 14 participants with post-concussion syndrome (PCS) tested a ketogenic diet (KD) for 2 months, showing that 11 participants successfully achieved ketosis and reported improvements in visual memory and symptom scores.
The ketogenic diet was found to be a feasible treatment option for PCS, with some participants experiencing symptom relief, although further research is needed to confirm its efficacy.
The Ketogenic Diet in the Treatment of Post-concussion Syndrome-A Feasibility Study.Rippee, MA., Chen, J., Taylor, MK.[2020]
A new ketogenic diet (KD) designed for adults significantly improved recovery from traumatic brain injury (TBI) in mice, showing reduced sensorimotor deficits and improved spatial memory over a 70-day study period.
The new-KD increased levels of Beta-hydroxybutyrate (β-HB) and enhanced the mTOR pathway, leading to reduced inflammation and tissue damage, suggesting it has therapeutic potential for treating TBI in adults.
A new ketogenic formulation improves functional outcome and reduces tissue loss following traumatic brain injury in adult mice.Thau-Zuchman, O., Svendsen, L., Dyall, SC., et al.[2021]
In a rat model of traumatic brain injury (TBI), the ketogenic diet (KD) increased the seizure threshold, meaning rats on the KD took longer to have seizures compared to those on a standard diet, particularly when the KD was maintained during seizure testing.
However, while KD reduced neuronal cell loss in the brain when administered before TBI, it did not prevent the development of epilepsy after the injury, indicating that KD may not be effective as a long-term antiepileptogenic treatment in this context.
Does ketogenic diet alter seizure sensitivity and cell loss following fluid percussion injury?Schwartzkroin, PA., Wenzel, HJ., Lyeth, BG., et al.[2017]

Citations

The Role of Ketogenic Diet in the Treatment ...Taking these results into account, the low-fat recommendations in AD ... Effects of an low carbohydrate/healthy fat/ketogenic diet on biomarkers of ...
Ketogenic Diet - Nutrition and Traumatic Brain Injury - NCBIThe traditional ketogenic diet consists of four parts fat to one part ... ketogenic diet does hold some promise of effectiveness in improving the outcomes of TBI.
11 Ketogenic Diet | Nutrition and Traumatic Brain InjuryThe traditional ketogenic diet consists of four parts fat to one part ... ketogenic diet does hold some promise of effectiveness in improving the outcomes of TBI.
Ketogenic Diets for Adult Neurological Disorders - PMCThe ketogenic diet (KD) is a high-fat, low-carbohydrate diet that induces ketone body production in the liver through fat metabolism. ... traumatic brain injury ...
Diet-induced ketosis in adult patients with subacute ...Phase I single center trial of ketogenic diet for adults with traumatic brain injury. ... Hypercaloric low-carbohydrate high-fat diet protects ...
Ketogenic Diet for Traumatic Brain Injury · Info for ParticipantsThe ketogenic diet is unique for traumatic brain injury as it shifts the body's energy source from carbohydrates to fats, producing ketones that may protect ...
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