Ketogenic Diet for Parkinson's Disease

(KIM Trial)

Overseen By Shayan Keymanesh, BSc. Neuroscience

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must be taking: Dopaminergic medications

Must not be taking: Insulin, Warfarin, Immunomodulators, Antibiotics

Disqualifiers: Atypical parkinsonism, Dysphagia, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the Mediterranean-Ketogenic diet to determine its safety and effectiveness for people with Parkinson's Disease. Parkinson's is a brain disorder that can also impact gut health, and the diet might help without disrupting the gut's balance. The study includes two groups trying different versions of the diet, such as a Mediterranean diet supplemented with medium-chain triglyceride oil, to identify the best approach. The trial seeks participants with Parkinson's who have had stable symptoms with medication for at least a month and do not have conditions like diabetes on insulin or significant swallowing issues. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance dietary management for Parkinson's patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on stable dopaminergic medication for at least one month before joining. If you are using immunomodulatory agents, probiotics, or antibiotics, you may need to stop before participating.

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

Studies have shown that both the Mediterranean-ketogenic diet and the Mediterranean diet with MCT oil are generally safe for people with Parkinson's disease. Participants reported feeling better, moving more easily, and experiencing less anxiety. Another study found these diets practical and manageable.

Research indicates that the Mediterranean diet with MCT oil is well-tolerated by people with Parkinson's. Participants gradually increased their MCT oil intake and found it manageable. However, more research is needed to fully understand its effects.

In summary, both diet plans appear safe and easy to follow for people with Parkinson's, with possible benefits for mood and movement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a Mediterranean-Ketogenic Diet for Parkinson's Disease because it offers a novel approach compared to standard treatments like medications that increase dopamine levels or deep brain stimulation. Unlike these typical options, which primarily focus on managing symptoms, the Mediterranean-Ketogenic Diet may impact the underlying disease processes by altering brain metabolism and reducing inflammation. Additionally, this dietary intervention is non-invasive and could provide a natural alternative or complement to existing therapies, potentially improving quality of life without the side effects commonly associated with medications.

What evidence suggests that this trial's treatments could be effective for Parkinson's Disease?

Studies have shown that ketogenic diets can improve symptoms in people with Parkinson's disease (PD), enhancing movement, mood, and thinking skills. In this trial, participants will follow either a Mediterranean-Ketogenic Diet or a Mediterranean diet supplemented with medium-chain triglyceride oil. The Mediterranean diet, known for its heart health benefits, is also associated with improved PD symptoms. Combining a Mediterranean and ketogenic diet aims to unite the benefits of both. Research suggests that this diet could help manage PD symptoms without disrupting the gut microbiome, which is crucial for overall health. ^{1 2 3 4 6}

Who Is on the Research Team?

Silke Appel-Cresswell, MD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for people aged 40-85 with Parkinson's Disease, who have a mild to moderate severity score (Hoehn & Yahr score of 1 to 3) and are on stable medication. It's not suitable for those outside this age range or disease severity, or whose treatment isn't consistent.

Inclusion Criteria

My Parkinson's disease is mild to moderately severe.

PD diagnosis based on Movement Disorder Society (MDS) criteria

I have been on stable Parkinson's medication for over a month.

Exclusion Criteria

I am taking drugs that modify my immune system.

I have inflammatory bowel disease.

I have severe difficulty swallowing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention 1: Mediterranean Ketogenic Diet (MeDi-KD)

Participants undergo an 8-week Mediterranean ketogenic diet intervention

8 weeks

Regular monitoring visits

Washout

Participants undergo an 8-week washout period between interventions

8 weeks

Intervention 2: Mediterranean Diet with Medium-Chain Triglycerides (MeDi-MCT)

Participants undergo an 8-week Mediterranean diet supplemented with medium-chain triglycerides

8 weeks

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mediterranean diet supplemented with medium-chain triglyceride oil
• Mediterranean-Ketogenic Diet

Trial Overview The study tests if a Mediterranean diet with added medium-chain triglyceride oil can be beneficial in Parkinson’s without disrupting the gut microbiome, compared to a standard Mediterranean-Ketogenic Diet.

How Is the Trial Designed?

Group I: MeDi(MCT-KD) Experimental Treatment 2 Interventions

The participants in this arm will first undergo the MeDi-MCT intervention followed by the MeDi-KD intervention, after an 8-week washout period.

Group II: MeDi(KD-MCT) Experimental Treatment 2 Interventions

The participants in this arm will first undergo the MeDi-KD intervention followed by the MeDi-MCT intervention, after an 8-week washout period.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Weston Family Foundation

Collaborator

Trials

4

Recruited

290+

Weston Family Foundation

Collaborator

Published Research Related to This Trial

Adherence to a Mediterranean diet is linked to a slower increase in the probability of developing prodromal Parkinson's disease (pPD) over a follow-up period of about 3 years, suggesting a protective effect against neurodegeneration.

Participants with higher adherence to the Mediterranean diet had a 60%-70% lower risk of developing possible/probable pPD compared to those with the lowest adherence, and each unit increase in the diet score was associated with a 9%-10% lower risk of developing Parkinson's disease or dementia with Lewy bodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean diet is associated with a lower probability of prodromal Parkinson's disease and risk for Parkinson's disease/dementia with Lewy bodies: A longitudinal study. Maraki, MI., Yannakoulia, M., Xiromerisiou, G., et al.[2023]

The Mediterranean Eating Pattern for Americans (MEPA-III) screener is a valid and feasible tool for assessing adherence to a Mediterranean diet in older adults with Parkinson's disease, showing a good correlation with the established VioScreen™ Food Frequency Questionnaire.

Participants found the MEPA-III screener acceptable and easy to use, with a median completion time of just over 4 minutes, making it a practical option for monitoring dietary patterns that may influence cognitive decline in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of an Online Screener, the Mediterranean Eating Pattern for Americans-III in Older Patients with Parkinson's Disease. Weaver, KE., Goldman, JG., Ribbens, N., et al.[2020]

A study of 600 Italian Parkinson's Disease patients showed that their adherence to the Mediterranean diet was similar to that of matched controls, indicating that dietary habits may not significantly differ in terms of overall diet quality despite some variations in food preferences.

Patients with Parkinson's Disease consumed less alcohol, fish, and fluids, and had a preference for softer foods due to swallowing difficulties, which could impact their nutritional management and hydration status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary habits in Parkinson's disease: Adherence to Mediterranean diet. Cassani, E., Barichella, M., Ferri, V., et al.[2018]

In a study involving seven volunteers with Parkinson's disease, five successfully followed a hyperketogenic diet for 28 days, which may help bypass defects in complex I activity associated with the disease.

All five participants showed improvements in their Unified Parkinson's Disease Rating Scale scores during the diet, although the possibility of a placebo effect cannot be excluded.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Parkinson disease with diet-induced hyperketonemia: a feasibility study. Vanitallie, TB., Nonas, C., Di Rocco, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12506048/

Modified Mediterranean diet effects on Parkinson's disease ... Epidemiological studies in PD patients suggest that a Mediterranean diet is associated with better motor and non-motor symptoms, slower ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10836553/

Dietary Interventions in Parkinson's Disease - PMC Participants will start the intervention by taking 5 mL of MCT oil twice daily for the first day and then gradually increase the dose to 14 g by the end of week ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05469997

Ketogenic Diet Interventions in Parkinson's Disease ... This study aims to investigate the safety of modified Mediterranean-ketogenic interventions that are thought to be safer alternatives to the classical KD.

4. nature.com nature.com/articles/s41420-023-01549-0

Neuroprotective effect of a medium-chain triglyceride ... Our results showed that a long-term medium-chain triglyceride KD (MCT-KD) significantly reduced MPTP-induced damage to dopaminergic (DA) neurons.

5. medrxiv.org medrxiv.org/content/10.1101/2025.04.01.25325057v1.full.pdf

A Randomized Safety and Feasibility Crossover Trial of two ... In this “Mediterranean-Ketogenic Interventions in Parkinson's Disease” (KIM) Trial, we describe the safety and feasibility outcomes from a phase ...

6. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-024-03603-5

A randomized feasibility trial of medium chain triglyceride ... An MCT-supplemented KD is feasible and acceptable to PD patients but requires further study to understand its effects on symptoms and disease.