Recruiting

Microbiome & Diet

Sponsor:

University of British Columbia

Code:

NCT06207136

Conditions

Parkinson Disease

Diet, Healthy

Gut Microbiome

Gastrointestinal Microbiome

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Mediterranean-style diet

Study Details

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

Parkinson Disease

Diet, Healthy

Gut Microbiome

Gastrointestinal Microbiome

Study ID

NCT06207136

Start date

Dec 3, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

Mediterranean-style diet

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

Primary outcome measure

  • Study retention [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Annie Kuan

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

Locations

UBC Pacific Parkinson's Research Centre

Recruiting

Vancouver, British Columbia, Canada, V6T 2B5

Contacts

Annie Kuan

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

More Information

Sponsor

University of British Columbia

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-03-23.