Ketogenic Diet Interventions in Parkinson's Disease: Safeguarding the Gut Microbiome (NCT05469997) | Clinical Trial Compass
CompletedNot Applicable
Ketogenic Diet Interventions in Parkinson's Disease: Safeguarding the Gut Microbiome
Canada52 participantsStarted 2023-03-01
Plain-language summary
Parkinson's Disease (PD) is the second most common neurodegenerative disorder with common gut-related symptoms, which are attributed to alterations in the gut microbiome - the collection of microorganisms that live within the gut. Classical ketogenic diets (KD) have shown to be beneficial in PD and non-PD populations but are associated with alterations in the gut microbiome that are characteristic of a perturbed system. This study aims to investigate the safety of modified Mediterranean-ketogenic interventions that are thought to be safer alternatives to the classical KD, as it relates to the gut microbiome health in patients with PD. We hypothesize that the modified Mediterranean-ketogenic interventions will not be associated with any significant perturbation of the gut microbiome in PD patients.
Who can participate
Age range
45 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 40-85 years
* PD diagnosis based on Movement Disorder Society (MDS) criteria \[52\]
* Hoehn \& Yahr score of 1 to 3
* On stable dopaminergic medication for at least one month
Exclusion Criteria:
* Atypical parkinsonism
* Medical or psychiatric conditions that would prevent full participation in the nutrition intervention
* Significant dysphagia
* Diabetes on insulin
* Anti-coagulation on warfarin
* Inflammatory bowel disease
* Dementia defined by Montreal Cognitive Assessment (MoCA) Scores of less than 21
* Inability to fill in electronic questionnaires or understand study instructions
* Use of immunomodulatory agents
* Probiotic use in the last 4 weeks (except for dietary sources such as yoghurt, kefir etc.), or antibiotic use in the last 3 months prior to the trial
* Use of MCT oil or on ketogenic diet in last 8 weeks prior to the trial
* Allergic to MCT oil, coconut oil, or coconut
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline and difference across interventions in measures of fecal and serum calprotectin, a biomarker for gut inflammation.
Changes from baseline and differences across interventions in other measures of gut health, namely short-chain fatty acid production, gut-barrier integrity, and microbial composition.