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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
Complicated mild (GCS 13-15), moderate (GCS 9 - 12) to severe (GCS ≤ 8) traumatic brain injury (TBI) between 2-30 days post injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have had a serious head injury within the past month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cerebral metabolism
Neurological outcome
Secondary outcome measures
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 more

Trial 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

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
304 Previous Clinical Trials
259,458 Total Patients Enrolled
Brenda Bartnik-Olson, PhDPrincipal InvestigatorLoma LInda University Medical Center
Duc Tran, MDPrincipal InvestigatorLoma LInda University Medical Center

Media Library

Ketogenic Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04530032 — N/A
Traumatic Brain Injury Research Study Groups: TBI KD/MAD, TBI SD
Traumatic Brain Injury Clinical Trial 2023: Ketogenic Diet Highlights & Side Effects. Trial Name: NCT04530032 — N/A
Ketogenic Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04530032 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there openings remaining in the experiment for participants?

"Unfortunately, clinicaltrials.gov reports that this trial is no longer accepting applicants as it was initially posted on December 7th 2020 and last updated on September 19th 2022. Despite this setback, there are 902 other trials still searching for enrollees at the present time."

Answered by AI

What is the primary purpose of this clinical investigation?

"The primary outcome evaluated over the 0 to 6 month period of this clinical trial is neurological improvement. Secondary outcomes include Neurocognitive changes, as measured by Delis Kaplan Executive Function System (D-KEFS), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Trail Making Test, Part B; all three being assessed across a 6 month time frame."

Answered by AI

Am I able to join the research project?

"Patients between the ages of 18 and 90 who have sustained wounds are eligible to take part in this study. They must also present with moderate (GCS 9-12) or extreme (GCS ≤ 8) traumatic brain injury, having occurred within 2-30 days prior to admission at LLU East Campus unit 1100 for acute rehabilitation services. The trial is limited to 30 participants only."

Answered by AI

Is there an upper age limit for enrolment in this investigation?

"According to the set parameters for this clinical trial, applicants must be 18 or above, and cannot exceed 90 years old."

Answered by AI
~5 spots leftby Dec 2024