Examining the effects of a Mediterranean diet on Parkinson's Disease

Canadian Parkinson's Microbiome Initiative: A Pilot Phase 2 Feasibility Randomized Controlled Trial of the MIND Diet in Parkinson's Disease

This study is trying out a Mediterranean diet for people with Parkinson's Disease to see if it helps improve their symptoms and overall health compared to a regular diet.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: University of British Columbia (Academic / other)
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT06207136 on ClinicalTrials.gov

What this trial studies

This pilot study aims to assess the feasibility and effects of an 18-month Mediterranean-style diet intervention compared to a standard diet in individuals living with Parkinson's Disease who do not have dementia. Participants will be randomly assigned to either diet group and will receive virtual nutrition coaching and cooking classes, along with regular in-person assessments at the University of British Columbia. The study will monitor changes in gut microbiome and Parkinson's symptoms, utilizing wearable devices to track physical activity and lifestyle factors throughout the intervention period.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40-80 with a clinical diagnosis of Parkinson's Disease who are cognitively stable and can commit to the study's requirements.

Not a fit: Patients with atypical parkinsonism, significant medical conditions, or those unable to participate fully in the nutrition intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into dietary interventions that may improve symptoms and quality of life for patients with Parkinson's Disease.

How similar studies have performed: While there is existing research linking Mediterranean diets to reduced risk and mortality in Parkinson's Disease, this specific intervention is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

Eligible if the person living with Parkinson's has/is:

1. a clinical diagnosis of PD,
2. cognitively stable (no clinical dementia),
3. between 40-80 years old,
4. able to travel to UBC for 6 onsite visits over 18 months,
5. sufficient English proficiency (coaching and cooking classes are in English only),
6. on a stable dopaminergic medication for at least one month before baseline,
7. computer and internet access at home, and can be available via video link for at least 80% of the study sessions.

Exclusion Criteria:

Not eligible, if person has/is:

1. a diagnosis of atypical parkinsonism,
2. medical or psychiatric conditions that would prevent full participation in the nutrition intervention (such as food allergies), significant dysphagia, diabetes on insulin, anti-coagulation on warfarin, and inflammatory bowel disease,
3. clinical dementia,
4. unable to complete questionnaires or understand study instructions,
5. using of immunomodulatory agents,
6. used Probiotics in the last 4 weeks prior to study start,
7. used Antibiotics in the last 3 months prior to study start,
8. contraindications for MRI.

Where this trial is running

Vancouver, British Columbia

• UBC Pacific Parkinson's Research Centre — Vancouver, British Columbia, Canada (Recruiting)

Study contacts

• Principal investigator: Silke Appel-Cresswell, MD, FRCPC — University of British Columbia
• Study coordinator: Annie Kuan

Conditions Parkinson Disease; Diet, Healthy; Gut Microbiome; Gastrointestinal Microbiome