Mediterranean-style diet for Parkinson's (NCT06207136)
Mediterranean diet improves Parkinson symptoms
- Trial ID
- NCT06207136
- Official Title
- Canadian Parkinson's Microbiome Initiative: A Pilot Phase 2 Feasibility Randomized Controlled Trial of the MIND Diet in Parkinson's Disease
- Goal
- Mediterranean diet improves Parkinson symptoms
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of British Columbia
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- Parkinson Disease, Diet, Healthy, Gut Microbiome, Gastrointestinal Microbiome
- Interventions
- Mediterranean-style diet
Summary For Families
The goal is to see if following a Mediterranean-style diet for 18 months is doable for people with Parkinson's and whether it changes the gut microbiome and Parkinson's symptoms compared with a standard diet, building on research that links Mediterranean eating patterns with lower Parkinson's risk and lower death rates. Participants are randomly assigned to the Mediterranean-style diet or a standard diet and get online nutrition coaching, group cooking classes, in-person visits at the University of British Columbia, a wearable wrist device to track movement, and stool, urine and blood samples with magnetic resonance imaging at the start and end. The study looks at who can be recruited and stay in the program so a larger trial can be planned. Eligible people are adults 40 to 80 with a clinical diagnosis of Parkinson's who do not have dementia, are on stable Parkinson's medications, can attend UBC visits and most online sessions in English; people with certain medical conditions or recent antibiotic or probiotic use are not eligible.
Locations
- UBC Pacific Parkinson's Research Centre, Vancouver, British Columbia, Canada
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Mediterranean-style diet. The goal is to see if following a Mediterranean-style diet for 18 months is doable for people with Parkinson's and whether it changes the gut microbiome and Parkinson's symptoms compared with a standard diet, building on research that links Mediterranean eating patterns with lower Parkinson's risk and lower death rates. Participants are randomly assigned to the Mediterranean-style diet or a standard diet and get online nutrition coaching, group cooking classes, in-person visits at the University of British Columbia, a wearable wrist device to track movement, and stool, urine and blood samples with magnetic resonance imaging at the start and end. The study looks at who can be recruited and stay in the program so a larger trial can be planned. Eligible people are adults 40 to 80 with a clinical diagnosis of Parkinson's who do not have dementia, are on stable Parkinson's medications, can attend UBC visits and most online sessions in English; people with certain medical conditions or recent antibiotic or probiotic use are not eligible.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 3 years and 1 month.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- Participants must attend 6 in-person visits over 18 months.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Blood draw (minimally invasive); Wearable / at-home monitoring (non-invasive); Questionnaires & surveys (non-invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.