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NCT Number: NCT06207136

Microbiome and 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Diet, Healthy Gastrointestinal Microbiome Gut Microbiome Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UBC Pacific Parkinson's Research Centre

Vancouver, British Columbia, V6T 2B5, Canada

Location status: Recruiting

Location contact

Annie Kuan

CONTACT

[email protected]

604-827-0576

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • a clinical diagnosis of PD,
  • cognitively stable (no clinical dementia),
  • between 40-80 years old,
  • able to travel to UBC for 6 onsite visits over 18 months,
  • sufficient English proficiency (coaching and cooking classes are in English only),
  • on a stable dopaminergic medication for at least one month before baseline,
  • 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:

  • a diagnosis of atypical parkinsonism,
  • 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,
  • clinical dementia,
  • unable to complete questionnaires or understand study instructions,
  • using of immunomodulatory agents,
  • used Probiotics in the last 4 weeks prior to study start,
  • used Antibiotics in the last 3 months prior to study start,
  • contraindications for MRI.

Treatment and study plan

Mediterranean-style Diet

Other

Coaching in the intervention diet group will promote higher consumption of healthier foods and cooking oils, while discouraging processed foods.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Annie Kuan

CONTACT

[email protected]

604-827-0576

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Weston Family Foundation

Registry information

Official study title

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

Acronym: PD-Diet

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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