Impact of Diet on the Microbiome-Immune-Brain Axis in Parkinson's Disease

Summary

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.

Conditions

• Parkinson Disease

Interventions

BEHAVIORAL

8 week predominantly plant-based New Nordic LPF-diet program

An 8-week patient-centered dietary intervention program will be implemented to maintain a predominantly plant-based New Nordic LPF-Diet.

BEHAVIORAL

maintenance of the predominantly plant-based New Nordic LPF-diet

Follow-up of long-term adherence to the diet at one and six months after completion of the intervention program.

Sponsors & Collaborators

• University Hospital Schleswig-Holstein

  collaborator OTHER

• University of Kiel

  lead OTHER

Principal Investigators

• Anja Bosy-Westphal, PhD, MD · Kiel University

• Eva Schäffer, MD · Kiel University, University Hospital Schleswig-Holstein

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2027-12-31

Completion

2028-07-31

Countries

• Germany

Study Locations