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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a ketogenic diet (high-fat, low-carb) can enhance motor and sensory functions, blood sugar control, and independence in individuals with spinal cord injuries. Participants will be divided into two groups: one will follow a standard hospital diet, and the other will follow a ketogenic diet for five weeks. Individuals with a spinal cord injury affecting movement or sensation, who do not have other major health conditions, might be suitable for this study.

As an unphased trial, this study provides a unique opportunity to explore potential dietary benefits for spinal cord injury recovery.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the ketogenic diet, high in fats and low in carbohydrates, has been studied for its effects on various health conditions. Studies have found that people generally tolerate this diet well. A review of several studies found that the ketogenic diet can be more effective than low-fat diets in improving certain health measures, suggesting it is safe for many to follow.

Some might experience minor side effects like tiredness or digestive issues initially, but these often improve as the body adjusts. In animal studies, a similar high-fat, low-carb diet was used without serious problems, providing some reassurance about its safety. However, studies in humans are always needed for more definite results.

Overall, current evidence suggests that the ketogenic diet is safe for many and could offer benefits. However, it's important to consider individual health conditions and consult a healthcare provider before starting any new diet plan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a ketogenic diet for spinal cord injury because it approaches healing in a unique way. Unlike standard care, which typically involves managing symptoms and rehabilitation, a ketogenic diet focuses on altering the body's metabolism. This high-fat, low-carbohydrate diet is thought to reduce inflammation and provide energy in a way that could support nerve repair and recovery. By shifting the body's energy production, it may offer a new avenue for improving outcomes in spinal cord injury patients.

What evidence suggests that the ketogenic diet might be an effective treatment for spinal cord injury?

Research has shown that the ketogenic diet, high in fat and low in carbohydrates, might improve brain and nerve function. Studies suggest this diet can protect nerve cells from damage and enhance movement after an injury. For example, one study found that a ketogenic diet improved movement in the front limbs of test subjects. The diet also helps manage conditions like epilepsy and Parkinson's disease, which affect the nervous system. In this trial, participants will join either a Ketogenic Diet Group or a Standard Diet Group to evaluate the potential benefits of a ketogenic diet on recovery and function after a spinal cord injury. ^{1 2 3 4 6}

Who Is on the Research Team?

Ceren Yarar-Fisher, PhD

Principal Investigator

Ohio State University

Raquel Minarsch, DPT

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7197123/

Evaluation of a ketogenic diet for improvement of neurological ... Dietary fat sources focus on animal and vegetable (for vegetarians) fats. Dietary fat resources for vegan participants include nuts, seeds, avocados and coconut ...

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04273-7

Evaluation of a ketogenic diet for improvement of neurological ... Dietary fat sources focus on animal and vegetable (for vegetarians) fats. Dietary fat resources for vegan participants include nuts, seeds, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3817084/

Ketogenic Diet Improves Forelimb Motor Function after ... We demonstrated for the first time that post-injury treatment of KD with a 3:1 ratio of fat to carbohydrates and proteins promoted neuroprotection and improved ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325000845

Unraveling Spinal Cord Injury Nutrition: Effects of Diet on ... Reducing intake of high-fat, processed foods and increasing healthier fats and dietary fiber can be a key strategy for improving recovery and overall health in ...

5. eneuro.org eneuro.org/content/7/4/ENEURO.0178-20.2020

The Effects of a Ketogenic Diet on Sensorimotor Function ... Ketogenic diets, which are high fat and low carbohydrate based, have been shown to be effective in treating epilepsy and Parkinson's disease ...

6. nature.com nature.com/articles/s41392-021-00831-w

Ketogenic diet for human diseases: the underlying ... Similarly, a meta-analysis of randomized controlled trials (RCTs) demonstrated that, compared to low-fat diets, KD more effectively improved the ...