Microbiome and Diet in Parkinson's Disease

NCT06207136 | Recruiting

• 1 other identifier: H23-03933
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dietary adherence

  18 months

• Optimization

  18 months

Study Arms (2)

Intervention healthy diet

EXPERIMENTAL

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

Standard diet

ACTIVE COMPARATOR

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

Interventions

Mediterranean-style diet OTHER

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

Intervention healthy diet; Standard diet

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Weston Family Foundation: collaborator

Study Sites (1)

UBC Pacific Parkinson's Research Centre

Vancouver, British Columbia, V6T 2B5, Canada

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Silke Appel-Cresswell, MD, FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annie Kuan

CONTACT

604-827-0576; annie.kuan@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Diet groups will be labelled without reference to the specific diet allocation (example: "Yellow cooking group" or "Blue cooking group") for all participant communication. Random assignment to either: 1. the active intervention diet group, or 2. the standard-of-care diet.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor Medicine, MD, FRCPC

Model Details: Intervention diet versus standard diet

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 16, 2024
• Study Start: December 3, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)