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

March 19, 2026 updated by: Silke Cresswell, University of British Columbia

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • Recruiting
        • UBC Pacific Parkinson's Research Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Study retention
Time Frame: 18 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Optimization
Time Frame: 18 months
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
Time Frame: 18 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Weston Family Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Silke Appel-Cresswell, MD, FRCPC, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 3, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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