Ketogenic Diet & Functional Recovery in Moderate to Severe Traumatic Brain Injury
Completed · Not applicable
Conditions studied: Traumatic Brain Injury
In brief
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.
Key facts
- Study ID
- NCT04530032
- Run by
- Loma Linda University
- People needed
- 21
- Starts
- 2020-12-07
- Expected to finish
- 2025-08-14
- Last updated by the study team
- 2026-02-04
Who can join
Age: 16 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Loma Linda University Health — Loma Linda, California, United States
Full record on ClinicalTrials.gov
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