Ketogenic Diet for Traumatic Brain Injury

Recruiting in Palo Alto (17 mi)

Overseen byDuc Tran, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Loma Linda University

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

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Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TBI KD/MADExperimental Treatment1 Intervention

TBI subjects on a ketogenic/modified Atkins diet

Group II: TBI SDPlacebo Group1 Intervention

TBI subjects on a standard (normal) diet