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

Sponsor
University of Kiel
Study ID
NCT06463769
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 8 week predominantly plant-based New Nordic LPF-diet program — BEHAVIORAL
    An 8-week patient-centered dietary intervention program will be implemented to maintain a predominantly plant-based New Nordic LPF-Diet.
  • maintenance of the predominantly plant-based New Nordic LPF-diet — BEHAVIORAL
    Follow-up of long-term adherence to the diet at one and six months after completion of the intervention program.

Study Details

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.

Key Dates

First listed
Jun 18, 2024
Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with prodromal PD on New Nordic LPF-diet (intervention)
    Patients with prodromal PD will take part in an 8-week patient-centered intervention program on a predominantly plant-based New Nordic LPF-Diet.
  • Experimental: Patients with clinical PD on New Nordic LPF-diet (intervention)
    Patients with clinical PD will take part in an 8-week patient-centered intervention program on a predominantly plant-based New Nordic LPF-Diet. Patients with clinical PD will be randomized to intervention or control group.
  • No Intervention: Patients with clinical PD receiving standard of care (control)
    Patients with clinical PD will receive standard of care information on a healthy diet and serve as control. Patients with clinical PD will be randomized to intervention or control group.

Primary Outcome Measure

abundance of key SCFA-producing gut bacteria [ Time Frame: pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention ]

Central Contacts

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