Ketogenic Diet for Spinal Cord Injury

Recruiting at 1 trial location

Overseen By Raquel Minarsch, DPT

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Pregnancy, Neurological, Cardiac, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 5 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this project is to determine if 5 weeks of ketogenic (KD, high-fat) diet vs. standard diet (SD) significantly improves motor and sensory function, glycemic function, and functional independence in patients with spinal cord injury.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the ketogenic diet treatment for spinal cord injury?

Research in rats shows that a ketogenic diet, which is high in fat and low in carbohydrates, can improve motor function and protect nerve cells after a spinal cord injury. Additionally, a pilot study in humans with spinal cord injury found that a ketogenic diet improved motor function and reduced inflammation compared to a standard diet. ^{1 2 3 4 5}

Is the ketogenic diet safe for humans with spinal cord injury?

Research suggests that the ketogenic diet is generally safe for humans, as it has been used in clinical settings for conditions like epilepsy and shows potential benefits for spinal cord injury recovery. Studies indicate it may improve motor function and reduce inflammation, with no major safety concerns reported. ^{1 2 3 5 6}

How does the ketogenic diet treatment differ from other treatments for spinal cord injury?

The ketogenic diet is unique because it uses a high-fat, low-carbohydrate approach to promote neuroprotection and improve motor function after spinal cord injury by increasing ketone levels, which serve as alternative energy sources for the brain and help reduce inflammation and protect nerve cells. ^{1 2 3 4 7}

Research Team

Ceren Yarar-Fisher, PhD

Principal Investigator

Ohio State University

Raquel Minarsch, DPT

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for individuals aged 19-60 with spinal cord injuries, classified as ASIA A, B, C or D. It's not suitable for pregnant women, those with kidney or liver issues, lung diseases, or other neurological/cardiac/vascular conditions that could affect testing.

Inclusion Criteria

I have a spinal cord injury and am between 19 and 60 years old.

My spinal cord injury is classified as ASIA A, B, C, or D.

Exclusion Criteria

I have kidney and liver problems confirmed by tests.

I have a lung condition.

I do not have heart, blood vessel, or nerve problems that could affect my participation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Baseline measurements are taken within 72 hours of injury, including motor and sensory function, serum glucose, and insulin concentration

1 week

1 visit (in-person)

Treatment

Participants receive either a ketogenic diet or standard diet for 5 weeks

5 weeks

3 visits (in-person) at baseline, 3 weeks, and 5 weeks

Follow-up

Participants are monitored for changes in functional independence, serum glucose, and insulin concentration

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Ketogenic Diet
• Standard Diet

Trial Overview The study compares the effects of a high-fat ketogenic diet versus a standard diet over five weeks on motor and sensory recovery in spinal cord injury patients. It also looks at changes in blood sugar control and independence.

Participant Groups

Group I: Standard Diet Group Experimental Treatment 1 Intervention

Patients will start to receive standard hospital diet within 72 hours of injury after completing their baseline measurements. Standard diet includes ≈35% total energy as fat, ≈27% as protein, and ≈44% as carbohydrate and fiber.

Group II: Ketogenic Diet Group Experimental Treatment 1 Intervention

Ketogenic diet is a high-fat, low-carbohydrate diet (lipid to carbohydrate + protein ratio of 3:1) that included ≈72% total energy as fat, ≈25% as protein, and ≈3% as carbohydrate during enteral feeding and ≈65% total energy as fat, ≈27% as protein, and ≈8% as carbohydrate and fiber during solid feeding. Patients will start receiving ketogenic diet within the 72 hours injury, after completing their baseline measurements.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

A ketogenic diet (KD) significantly improved forelimb function and neuroprotection in rats with acute cervical spinal cord injury, showing benefits like increased range of motion and better movement recovery over a 14-week period.

The neuroprotective effects of the KD were linked to the function of monocarboxylate transporters (MCTs), which are crucial for ketone uptake, suggesting that dietary guidelines should be reconsidered to potentially include lower carbohydrate levels for better recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic diet improves forelimb motor function after spinal cord injury in rodents. Streijger, F., Plunet, WT., Lee, JH., et al.[2022]

In a clinical trial involving 10 patients with acute spinal cord injury, the ketogenic diet (KD) was found to safely increase blood ketone levels while maintaining normal blood glucose levels, indicating its feasibility as a dietary intervention.

The average motor function score improved slightly after KD treatment, although gastrointestinal issues were reported in some patients, all of which were manageable with symptomatic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A clinical trial of ketogenic diet in patients with acute spinal cord injury: safety and feasibility]. Guo, C., Zhou, J., Wu, X., et al.[2017]

Exogenous ketone supplementation combined with a ketogenic diet rapidly increases ketone levels in the blood of rats following spinal cord injury, potentially enhancing neuroprotection compared to ketogenic diet alone.

The KD + KS treatment resulted in improved motor function recovery, as evidenced by better performance in tasks assessing forelimb abilities, indicating that inducing ketosis may be beneficial after neurotrauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprotective effects of a ketogenic diet in combination with exogenous ketone salts following acute spinal cord injury. Tan, BT., Jiang, H., Moulson, AJ., et al.[2020]

A ketogenic diet (KD) administered for 7 days after spinal cord injury (SCI) in rats significantly improved mitochondrial function and respiratory capacity, suggesting a neuroprotective effect.

The KD also enhanced mitochondrial biogenesis and activated antioxidant pathways, indicating its potential as a treatment strategy for acute SCI in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenesis controls mitochondrial gene expression and rescues mitochondrial bioenergetics after cervical spinal cord injury in rats. Seira, O., Kolehmainen, K., Liu, J., et al.[2021]

The ketogenic diet (KD) is being tested for safety and feasibility in 60 individuals with acute spinal cord injuries, aiming to improve motor and sensory functions over 5 weeks compared to a standard diet.

Preliminary results from a pilot study suggest that KD may enhance upper extremity motor function and reduce neuroinflammatory markers, indicating potential benefits for neurological recovery in spinal cord injury patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a ketogenic diet for improvement of neurological recovery in individuals with acute spinal cord injury: study protocol for a randomized controlled trial. Demirel, A., Li, J., Morrow, C., et al.[2021]

The ketogenic diet (KD) is a promising dietary modification that may reduce the need for pharmaceutical treatments in managing acute and chronic neurological disorders, based on a review of human and animal studies.

Evidence suggests that the KD can enhance recovery from spinal cord and traumatic brain injuries by improving motor function, reducing neuroinflammation, and potentially influencing cellular energy processes, although the exact mechanisms are still being studied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic regimens for acute neurotraumatic events. Yarar-Fisher, C., Li, J., Womack, ED., et al.[2022]

A ketogenic diet (KD) and 1,3-butanediol (BD) significantly increased serum ketone levels in rats after spinal cord injury (SCI), which was associated with reduced inflammation and enhanced recovery of function, particularly in the use of the ipsilateral forelimb.

The KD and BD groups showed a shift in macrophage polarization towards the M2 phenotype, which is linked to tissue repair, while inflammatory markers were inhibited, suggesting that ketogenic metabolism may help mitigate damage and promote healing after SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprotective Effect of Ketone Metabolism on Inhibiting Inflammatory Response by Regulating Macrophage Polarization After Acute Cervical Spinal Cord Injury in Rats. Lin, J., Huang, Z., Liu, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ketogenic diet improves forelimb motor function after spinal cord injury in rodents. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[A clinical trial of ketogenic diet in patients with acute spinal cord injury: safety and feasibility]. [2017]

3. India pubmed.ncbi.nlm.nih.gov

Neuroprotective effects of a ketogenic diet in combination with exogenous ketone salts following acute spinal cord injury. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Ketogenesis controls mitochondrial gene expression and rescues mitochondrial bioenergetics after cervical spinal cord injury in rats. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of a ketogenic diet for improvement of neurological recovery in individuals with acute spinal cord injury: study protocol for a randomized controlled trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Ketogenic regimens for acute neurotraumatic events. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Neuroprotective Effect of Ketone Metabolism on Inhibiting Inflammatory Response by Regulating Macrophage Polarization After Acute Cervical Spinal Cord Injury in Rats. [2022]