Health TrialsbyHealthPanel

Microbiome and Diet in Parkinson's Disease

ConditionsParkinson DiseaseDiet, HealthyGut MicrobiomeGastrointestinal Microbiome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorUniversity of British Columbia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mediterranean-style diet

    Other intervention

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intervention healthy dietExperimental treatment 1 intervention
Group B: Standard dietActive comparator 1 intervention

Trial outcomes

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.

Time frame
18 months

Secondary outcomes

1

Dietary adherence

Adherence rate will be determined by the target score of 78% on the food diary for the intervention group, and target score of 57% by the standard group.

Time frame
18 months
2

Optimization

Qualitative outcomes by measuring participant input and feedback on trial design and execution as well as blinding procedures and developing standard operating procedures for clinical data collection, MRI acquisition, biological sample collection, pre-processing, storage, shipping and distribution of samples, and analyzing standard meals for nutrient content.

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

Weston Family Foundation

Collaborator

Source ClinicalTrials.gov
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