NCT05469997Completed
Ketogenic Diet Interventions in Parkinson's Disease: Safeguarding the Gut Microbiome
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 15 Jun 2022
- Start date
- 1 Mar 2023
- Primary completion date
- 30 Oct 2024
- Lead sponsor
- University of British Columbia
- Diseases
- Parkinson disease
- NCT number
- NCT05469997
What you commit to
- Study type: Interventional
- Participants enrolled: 52
- From 1 Mar 2023 to the primary completion date, 30 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Medical or psychiatric conditions that would prevent full participation in the nutrition intervention
- Diabetes on insulin
- Inflammatory bowel disease
- Dementia defined by Montreal Cognitive Assessment (MoCA) Scores of less than 21
- Allergic to MCT oil, coconut oil, or coconut
Other
- Atypical parkinsonism
- Significant dysphagia
- Anti-coagulation on warfarin
- Inability to fill in electronic questionnaires or understand study instructions
- Use of immunomodulatory agents
Who the study is looking for
- 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
Age in the registry: 45 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Djawad Mowafaghian Centre for Brain Health Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
Related publications
- A randomized safety and feasibility crossover trial of two Mediterranean-ketogenic interventions in individuals with Parkinson's disease.J Parkinsons Dis · 2026 · PMID 41637153
- Exploring the Facilitators and Barriers of Adherence to Mediterranean-Ketogenic Dietary Interventions in Parkinson's Disease: A Qualitative Study.Curr Dev Nutr · 2025 · PMID 41341605
This page is information, not medical advice. Discuss any trial with your doctor.