← Back to Search

Other

Ketogenic Diet for Traumatic Brain Injury (KETI Trial)

Q: What is the scope of this research effort in terms of participants?

Affirmative. Per the clinicaltrials.gov registry, this medical experiment is actively recruiting participants since its initial posting on July 4th 2019 and was recently updated on November 4th 2022. The investigators require 10 volunteers to be recruited from a single site.

Q: Are enrollments for this experiment open at the present?

According to the clinicaltrials.gov information, this research project is still in need of volunteers and was first posted on July 4th 2019 with its most recent amendment being made on November 4th 2022.

Q: What are the primary aims of this research project?

This trial has the primary purpose of establishing ketosis as indicated by blood tests. Secondary objectives include monitoring gastrointestinal reactions, assessing muscle wasting through urinary nitrogen and creatinine levels, and tracking alterations in lipid profiles via weekly lipid paneling. Evaluation will take place over a period not exceeding one month from baseline.

Phase < 1

Recruiting

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age more than 18years

Severe Traumatic Brain Injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, till patient on kd (maximum 1month)

Awards & highlights

KETI Trial Summary

This trial is testing whether the ketogenic diet is safe and feasible to help people with TBI recover neurons faster without causing significant side effects.

Who is the study for?

This trial is for adults over 18 with severe traumatic brain injury (GCS ≤ 8). It's not suitable for those with coagulopathy, diabetic ketoacidosis, unstable metabolic conditions, imminent mortality, pregnancy, pancreatitis, cardiorespiratory instability, liver failure, severe hyperlipidemia or certain metabolic disorders.Check my eligibility

What is being tested?

The study investigates the safety and effectiveness of a ketogenic diet in aiding recovery after a severe traumatic brain injury. The focus is on whether this high-fat, low-carbohydrate diet can help reduce the size of brain contusions and speed up neuron recovery.See study design

What are the potential side effects?

Potential side effects may include digestive issues due to high fat intake; however specific side effects are not listed as the trial aims to assess the overall safety profile of a ketogenic diet in this context.

KETI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 years old.

Select...

I have had a severe brain injury.

Select...

I have a severe head injury with a low consciousness level.

Select...

I am older than 18 years.

KETI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, till patient on kd (maximum 1month)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, till patient on kd (maximum 1month)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, till patient on kd (maximum 1month) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Development of Ketosis in blood

Effect of Ketogenic Diet on Intracranial Pressure

Excretion of Ketones in Urine

Secondary outcome measures

Evaluate change in the neurological exam

Evaluate subjects for muscle wasting

Evaluate subjects with gastro-intestinal adverse effects

KETI Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects on Ketogenic dietExperimental Treatment1 Intervention

Treatment with KD will consist of 4:1 [fat]: [protein + carbohydrate] weight ratio. KD will be started as soon as the patient is ready for alimentation (while they are in neurocritical care unit). The rate of feeds will be calculated by trained dietician on service. Ketogenic diet will be continued during the entire length of ICU stay. Supplementation with vitamins, calcium and phosphorus will be done.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor

362 Previous Clinical Trials

628,104 Total Patients Enrolled

Media Library

Ketogenic Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03982602 — Phase < 1

Traumatic Brain Injury Research Study Groups: Subjects on Ketogenic diet

Traumatic Brain Injury Clinical Trial 2023: Ketogenic Diet Highlights & Side Effects. Trial Name: NCT03982602 — Phase < 1

Ketogenic Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03982602 — Phase < 1

Frequently Asked Questions

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

What is the scope of this research effort in terms of participants?

"Affirmative. Per the clinicaltrials.gov registry, this medical experiment is actively recruiting participants since its initial posting on July 4th 2019 and was recently updated on November 4th 2022. The investigators require 10 volunteers to be recruited from a single site."

Answered by AI

Are enrollments for this experiment open at the present?

"According to the clinicaltrials.gov information, this research project is still in need of volunteers and was first posted on July 4th 2019 with its most recent amendment being made on November 4th 2022."

Answered by AI

What are the primary aims of this research project?

"This trial has the primary purpose of establishing ketosis as indicated by blood tests. Secondary objectives include monitoring gastrointestinal reactions, assessing muscle wasting through urinary nitrogen and creatinine levels, and tracking alterations in lipid profiles via weekly lipid paneling. Evaluation will take place over a period not exceeding one month from baseline."

Answered by AI