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Ketogenic Diet for Traumatic Brain Injury
N/A
Waitlist Available
Led By Brenda Bartnik-Olson, PhD
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to 12 months
Summary
This trial is investigating whether a short-term ketogenic diet can improve neurocognitive outcomes following a moderate-severe TBI.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from following a ketogenic or modified Atkins diet may include digestive discomforts like constipation or diarrhea, possible nutrient deficiencies if not properly managed and monitored by medical professionals. Specific side effects will depend on individual health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in cerebral metabolism
Neurological outcome
Secondary study objectives
Neurocognitive outcome: 36 Item Short Form Survey (SF-26)
Neurocognitive outcome: Delis Kaplan Executive Function System (D-KEFS)
Neurocognitive outcome: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
+1 moreTrial Design
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
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Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
314 Previous Clinical Trials
266,460 Total Patients Enrolled
Brenda Bartnik-Olson, PhDPrincipal InvestigatorLoma LInda University Medical Center
Duc Tran, MDPrincipal InvestigatorLoma LInda University Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe difficulty speaking or understanding language.Your prealbumin levels are very low when you are admitted to the study.You have a history of a neurological disorder or surgery on the brain or nerves before getting sick.You have a low GCS score because of recent intoxication.You have had a stroke caused by reduced blood flow to the brain after a serious head injury.You have high cholesterol.You have certain metabolic disorders that make it unsafe for you to follow a ketogenic diet.You have a history of brain injury with loss of consciousness.You have a history of mental health issues.You have severe kidney problems.You had surgery on your abdomen during this hospital stay.You have type 1 diabetes.You have a condition called gastroparesis.You have metal implants, are pregnant, have claustrophobia, or can't have an MRI for other medical reasons.Your liver enzymes are more than 5 times the normal level, or you have chronic cirrhosis.You have had a serious head injury within the past month.
Research Study Groups:
This trial has the following groups:- Group 1: TBI KD/MAD
- Group 2: TBI SD
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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