Ketogenic Diet & Functional Recovery in Moderate to Severe Traumatic Brain Injury

NCT04530032 | Completed

• 1 other identifier: 5200137
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury; ketogenic diet; metabolism; spectroscopy; cerebral blood flow; modified Atkins diet

Outcome Measures

Primary Outcomes (2)

• Neurological 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).

  day 0 to 12 months

• Change in cerebral metabolism

  Single voxel magnetic resonance spectroscopy will be used to assess changes in cerebral metabolism as a result of the dietary intervention.

  day 0 to 12 months

Secondary Outcomes (4)

• Neurocognitive outcome: Trail Making Test, Part B

  day 0 to 12 months

• Neurocognitive outcome: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  day 0 to 12 months

• Neurocognitive outcome: Delis Kaplan Executive Function System (D-KEFS)

  day 0 to 12 months

• Neurocognitive outcome: 36 Item Short Form Survey (SF-26)

  day 0 to 12 months

Study Arms (2)

TBI KD/MAD

EXPERIMENTAL

TBI subjects on a ketogenic/modified Atkins diet

Other: ketogenic/modified Atkins diet

TBI SD

SHAM COMPARATOR

TBI subjects on a standard (normal) diet

Other: Standard diet

Interventions

ketogenic/modified Atkins diet OTHER

ketogenic/modified Atkins diet use

TBI KD/MAD

Standard diet OTHER

standard (normal) diet use

TBI SD

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Brenda Bartnik-Olson, PhD

  Loma LInda University Medical Center

  PRINCIPAL INVESTIGATOR

• Duc Tran, MD

  Loma LInda University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 28, 2020
• Study Start: December 7, 2020
• Primary Completion: August 14, 2025
• Study Completion: August 14, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)