Microbiome and Diet in Parkinson's Disease

NCT ID: NCT06207136

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-03
• Study Completion Date: 2027-12-31

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.

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Mediterranean-style diet

Intervention Type: OTHER

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

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).

Group Type: ACTIVE_COMPARATOR

Mediterranean-style diet

Intervention Type: OTHER

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

Interventions

Mediterranean-style diet

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weston Family Foundation

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Silke Cresswell

Principal Investigator, Associate Professor Medicine, MD, FRCPC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silke Appel-Cresswell, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

UBC Pacific Parkinson's Research Centre

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Annie Kuan

Role: CONTACT

annie.kuan@ubc.ca

604-827-0576

Facility Contacts

Annie Kuan

Role: primary

annie.kuan@ubc.ca

604-827-0576

Other Identifiers

H23-03933

Identifier Type: -

Identifier Source: org_study_id