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

NCT04530032 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-02-04

No results posted yet for this study

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

Interventions

OTHER

ketogenic/modified Atkins diet

ketogenic/modified Atkins diet use

OTHER

Standard diet

standard (normal) diet use

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Brenda Bartnik-Olson, PhD · Loma LInda University Medical Center

  • Duc Tran, MD · Loma LInda University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-07
Primary Completion
2025-08-14
Completion
2025-08-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04530032 on ClinicalTrials.gov