NCT06463769Not yet recruiting
Impact of Diet on the Microbiome-Immune-Brain Axis in Parkinson's Disease
"Impact of Diet on the Microbiome-Immune-Brain Axis in Parkinson's Disease" as Part of the Collaborative Research Center 1697 "Targeting the Microbiome-Immune-Brain Interaction in Neurodegeneration"
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
Habitual adherence to a predominantly plant-based diet, rich in low-processed food (LPF) has been associated with a reduced risk for development and slower progression of Parkinson's Disease (PD). This could be due to neuroprotective effects by modulation of the gut microbiota and decreased neuronal and metabolic inflammation. So far, the effect of a predominantly plant-based LPF-diet on the microbiome-immune-brain axis in patients with PD remains unknown. In addition, the influence of dietetic measures on the gut microbiome is variable and may depend on (long-term) adherence as well as on PD-specific factors and lifestyle. The investigators hypothesize that compared to an average German diet, the predominantly plant-based New Nordic LPF-diet, as a culturally adapted diet, which is rich in fermentable fiber and phytochemicals, will have beneficial effects on the gut microbiome of patients with PD by increasing the abundance of short-chain fatty acid (SCFA)-producing bacteria (primary outcome) and will improve gut motility, metabolic resilience, and inflammation (secondary outcomes). Furthermore, the investigators postulate that a patient-centered dietary intervention program, including a multifaceted patient education and supported by a web-application, will lead to high adherence as a key determinant of long-term changes in the gut microbiome. This dietary intervention will be accepted by patients as a low-threshold treatment that balances personal benefits, therapeutic barriers and ethical concerns of early risk disclosure in PD.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 5 Jun 2024
- Start date
- May 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- University of Kiel
- Diseases
- Parkinson disease
- NCT number
- NCT06463769
What you commit to
- Study type: Interventional
- Planned participants: 75
- From May 2026 to the primary completion date, Dec 2027
- 2 sites 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
- expected changes in medication or antibiotic treatment during the intervention
Other illness
- food allergies or intolerances
- significant diseases of the gastrointestinal system (e.g. celiac disease) or central nervous system, diabetes mellitus
Other
- current adherence to a plant-based diet
- underweight (BMI \<18.5 kg/m2)
- active smoking
Who the study is looking for
- patients with probable prodromal PD (according to predefined criteria)
- patients with clinical PD with slight to moderate disease severity (Hoehn \& Yahr 1-2.5)
- habitual Western Diet (≥30% of energy intake from ultra-processed food)
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kiel University, University Hospital Schleswig-Holstein Coordinator of this site? Confirm its status | Kiel | Germany | Unknown status |
| Institute of Human Nutrition Coordinator of this site? Confirm its status | Kiel | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.