50 Participants Needed

Ketogenic Diet for Parkinson's Disease

(KIM Trial)

SK
Overseen ByShayan Keymanesh, BSc. Neuroscience
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of British Columbia
Must be taking: Dopaminergic medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.25678

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.24679

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.

Research Team

SA

Silke Appel-Cresswell, MD

Principal Investigator

University of British Columbia

Eligibility Criteria

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.
See 1 more

Exclusion Criteria

I am taking drugs that modify my immune system.
I have inflammatory bowel disease.
I have severe difficulty swallowing.
See 9 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: MeDi(MCT-KD)Experimental Treatment2 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 Treatment2 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.

Find a Clinic Near You

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

Findings from Research

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.
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.
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.
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]

References

Ketogenic therapy for Parkinson's disease: A systematic review and synthesis without meta-analysis of animal and human trials. [2022]
Dietary habits in Parkinson's disease: Adherence to Mediterranean diet. [2018]
Validation of an Online Screener, the Mediterranean Eating Pattern for Americans-III in Older Patients with Parkinson's Disease. [2020]
Effects of a Ketogenic Diet on Symptoms, Biomarkers, Depression, and Anxiety in Parkinson's Disease: A Case Study. [2022]
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]
A Review of Ketogenic Dietary Therapies for Epilepsy and Neurological Diseases: A Proposal to Implement an Adapted Model to Include Healthy Mediterranean Products. [2023]
Treatment of Parkinson disease with diet-induced hyperketonemia: a feasibility study. [2022]
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]
The efficacy of the ketogenic diet on motor functions in Parkinson's disease: A rat model. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security