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

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Parkinson's Disease (PD) is the second most common neurodegenerative disorder with common gut-related symptoms, which are attributed to alterations in the gut microbiome - the collection of microorganisms that live within the gut. Classical ketogenic diets (KD) have shown to be beneficial in PD and non-PD populations but are associated with alterations in the gut microbiome that are characteristic of a perturbed system. This study aims to investigate the safety of modified Mediterranean-ketogenic interventions that are thought to be safer alternatives to the classical KD, as it relates to the gut microbiome health in patients with PD. We hypothesize that the modified Mediterranean-ketogenic interventions will not be associated with any significant perturbation of the gut microbiome in PD 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 the ketogenic diet safe for people with Parkinson's disease?

The ketogenic diet, including versions with Mediterranean influences, has been studied for safety in various conditions. It is generally considered safe, but substituting unsaturated fats for saturated ones may help prevent cholesterol increases. More research is needed to fully understand its safety in Parkinson's disease. ^{1 2 3 4 5}

How does the Mediterranean-Ketogenic Diet treatment differ from other treatments for Parkinson's disease?

The Mediterranean-Ketogenic Diet is unique because it combines the high-fat, low-carbohydrate approach of the ketogenic diet with the heart-healthy principles of the Mediterranean diet, using olive oil and vegetable fats instead of saturated fats. This approach may help improve Parkinson's symptoms by providing an alternative energy source for the brain and potentially reducing cholesterol levels. ^{1 3 4 6 7}

What data supports the effectiveness of the Mediterranean-Ketogenic Diet treatment for Parkinson's Disease?

Research shows that a ketogenic diet can improve health markers and reduce symptoms of anxiety and Parkinson's Disease in patients, while a Mediterranean diet is linked to slower cognitive decline and a lower risk of developing Parkinson's Disease. ^{2 3 7 8 9}

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

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]

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]

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]

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. Ireland pubmed.ncbi.nlm.nih.gov

Ketogenic therapy for Parkinson's disease: A systematic review and synthesis without meta-analysis of animal and human trials. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Dietary habits in Parkinson's disease: Adherence to Mediterranean diet. [2018]

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

Validation of an Online Screener, the Mediterranean Eating Pattern for Americans-III in Older Patients with Parkinson's Disease. [2020]

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

Effects of a Ketogenic Diet on Symptoms, Biomarkers, Depression, and Anxiety in Parkinson's Disease: A Case Study. [2022]

5. England 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. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Review of Ketogenic Dietary Therapies for Epilepsy and Neurological Diseases: A Proposal to Implement an Adapted Model to Include Healthy Mediterranean Products. [2023]

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

Treatment of Parkinson disease with diet-induced hyperketonemia: a feasibility study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Effects of an low carbohydrate/healthy fat/ketogenic diet on biomarkers of health and symptoms, anxiety and depression in Parkinson's disease: a pilot study. [2022]

9. Iran pubmed.ncbi.nlm.nih.gov

The efficacy of the ketogenic diet on motor functions in Parkinson's disease: A rat model. [2020]