Microbiome and Diet in Parkinson's Disease (PD-Diet)

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

The goal of this pilot study is to examine the feasibility and effects of an 18-month intervention diet compared to an active control diet (standard diet) in those living with Parkinson's Disease (PD), without dementia.

Research has shown that eating components of Mediterranean diets are associated with a 30% lower risk to develop PD and a 40% lower mortality rate in those living with PD. Diet may influence the gut and microbiomes, thus may affect PD risk and progression.

This study will examine how easy it will be to adhere to a certain type of diet for 18 months and what changes may occur in the gut microbiome and in PD symptoms on a specific diet during that time.

The study will involve in-person study visits at UBC as well as online diet coaching sessions and online group cooking classes over Zoom.

This is a randomized study, meaning that participants will be assigned by chance to either the Mediterranean-style diet group or the standard diet group for the duration of the 18 months.

This pilot study will also examine recruitment rates and retention, in order to prepare for a larger future study.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Diet, Healthy; Gastrointestinal Microbiome; Gut Microbiome
• Intervention / Treatment: Other: Mediterranean-style diet

Detailed Description

Those meeting general eligibility criteria and are agreeable, will come to the University of British Columbia (UBC) for an onsite Screening visit to sign the consent form, review eligibility, and complete assessments. If the additional study criteria is met during the Screening and the 4-week run-in phase, an onsite Baseline assessment will occur over 2 days. At Baseline, each participant will be randomized to either (1) the "yellow cooking group", or (2) the "blue cooking group". Participants will remain in their assigned groups for the duration of the study. Participants will also be provided with a wearable wrist device to record daily physical movement and lifestyle factors during the 18 months.

Participants in both groups will receive virtual/remote coaching (nutrition training) and group cooking classes, and also complete questionnaires (at home and in-person) and collect biological samples (urine, faecal). Onsite (in-person) visits will occur at Screening, Baseline, 3 months, 6 months, 12 months, and 18 months (end); these will include questionnaires, blood sample collections, participant feedback, magnetic resonance imaging (MRI) scans (Baseline and 18 months only).

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annie Kuan; Phone Number: 604-827-0576; Email: annie.kuan@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 2B5
      • Recruiting
      • UBC Pacific Parkinson's Research Centre
      • Contact: Annie Kuan; Phone Number: 604-827-0576; Email: annie.kuan@ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention healthy diet; Participants in the active intervention group will have specific diet advice delivered with motivational and behaviour-change techniques and will learn relevant cooking skills in remotely-delivered group cooking classes (via Zoom).	Other: Mediterranean-style diet; Coaching in the intervention diet group will promote higher consumption of healthier foods and cooking oils, while discouraging processed foods.
Active Comparator: Standard diet; The active control group will focus on an energy-adequate diet considered standard-of-care but similar to the participant's baseline diet. The control dietary intervention group will receive general diet advice and standard care and will receive instruction in cooking skills delivered in remote group cooking classes (via Zoom).	Other: Mediterranean-style diet; Coaching in the intervention diet group will promote higher consumption of healthier foods and cooking oils, while discouraging processed foods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study retention	The rate of study retention and recruitment, by calculating study completion rates and mean recruitments per month. The recruitment goal is 54, with an estimated drop-out rate of 25%, with the expectation of 40 completing the 18-month intervention.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimization	Qualitative outcomes by measuring participant input and feedback on trial design and execution as well as blinding procedures and developing standard operating procedures for clinical data collection, MRI acquisition, biological sample collection, pre-processing, storage, shipping and distribution of samples, and analyzing standard meals for nutrient content.	18 months
Dietary adherence	Adherence rate will be determined by the target score of 78% on the food diary for the intervention group, and target score of 57% by the standard group.	18 months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Weston Family Foundation
• Investigators: Principal Investigator: Silke Appel-Cresswell, MD, FRCPC, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: H23-03933

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No