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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Canada
UBC Pacific Parkinson's Research Centre
RECRUITING
Vancouver
Contact Information
Primary
Annie Kuan
annie.kuan@ubc.ca
604-827-0576
Time Frame
Start Date: 2024-12-03
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 40
Treatments
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).
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).
Related Therapeutic Areas
Sponsors
Collaborators: Weston Family Foundation
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov