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

NCT06463769 | Not Yet Recruiting

• 1 other identifier: CRC1697-C04
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

New Nordic Diet; Parkinson's Disease; Microbiome-Immune-Brain axis

Outcome Measures

Primary Outcomes (1)

• abundance of key SCFA-producing gut bacteria

  analysis of stool samples

  pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention

Secondary Outcomes (5)

• systemic inflammation markers

  pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention

• metabolic resilience

  pre vs. post intervention (8 weeks)

• gastrointestinal peptide-hormones

  pre vs. post intervention (8 weeks)

• energy balance

  pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention

• energy partitioning

  pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention

Other Outcomes (10)

• clinical motor symptoms

  pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention

• clinical non-motor symptoms

  pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention

• gastric emptying

  pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention

Study Arms (3)

Patients with prodromal PD on New Nordic LPF-diet (intervention)

EXPERIMENTAL

Patients with prodromal PD will take part in an 8-week patient-centered intervention program on a predominantly plant-based New Nordic LPF-Diet.

Behavioral: 8 week predominantly plant-based New Nordic LPF-diet program; Behavioral: maintenance of the predominantly plant-based New Nordic LPF-diet

Patients with clinical PD on New Nordic LPF-diet (intervention)

EXPERIMENTAL

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.

Behavioral: 8 week predominantly plant-based New Nordic LPF-diet program; Behavioral: maintenance of the predominantly plant-based New Nordic LPF-diet

Patients with clinical PD receiving standard of care (control)

NO INTERVENTION

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.

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.

Patients with clinical PD on New Nordic LPF-diet (intervention); Patients with prodromal PD on New Nordic LPF-diet (intervention)

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.

Patients with clinical PD on New Nordic LPF-diet (intervention); Patients with prodromal PD on New Nordic LPF-diet (intervention)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• current adherence to a plant-based diet
• food allergies or intolerances
• significant diseases of the gastrointestinal system (e.g. celiac disease) or central nervous system, diabetes mellitus
• underweight (BMI \<18.5 kg/m2)
• active smoking
• expected changes in medication or antibiotic treatment during the intervention

Sponsors & Collaborators

• University of Kiel: lead
• University Hospital Schleswig-Holstein: collaborator

Study Sites (2)

Institute of Human Nutrition

Kiel, 24105, Germany

Location

Kiel University, University Hospital Schleswig-Holstein

Kiel, 24105, Germany

Location

Related Publications (3)

• Aho VTE, Houser MC, Pereira PAB, Chang J, Rudi K, Paulin L, Hertzberg V, Auvinen P, Tansey MG, Scheperjans F. Relationships of gut microbiota, short-chain fatty acids, inflammation, and the gut barrier in Parkinson's disease. Mol Neurodegener. 2021 Feb 8;16(1):6. doi: 10.1186/s13024-021-00427-6.

  PMID: 33557896 BACKGROUND

• Solch RJ, Aigbogun JO, Voyiadjis AG, Talkington GM, Darensbourg RM, O'Connell S, Pickett KM, Perez SR, Maraganore DM. Mediterranean diet adherence, gut microbiota, and Alzheimer's or Parkinson's disease risk: A systematic review. J Neurol Sci. 2022 Mar 15;434:120166. doi: 10.1016/j.jns.2022.120166. Epub 2022 Jan 26.

  PMID: 35144237 BACKGROUND

• Maraki MI, Yannakoulia M, Stamelou M, Stefanis L, Xiromerisiou G, Kosmidis MH, Dardiotis E, Hadjigeorgiou GM, Sakka P, Anastasiou CA, Simopoulou E, Scarmeas N. Mediterranean diet adherence is related to reduced probability of prodromal Parkinson's disease. Mov Disord. 2019 Jan;34(1):48-57. doi: 10.1002/mds.27489. Epub 2018 Oct 10.

  PMID: 30306634 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Anja Bosy-Westphal, PhD, MD

  Kiel University

  PRINCIPAL INVESTIGATOR

• Eva Schäffer, MD

  Kiel University, University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anja Bosy-Westphal, PhD, MD

CONTACT

+494318805674; abosyw@nutrition.uni-kiel.de

Eva Schäffer, MD

CONTACT

+49431 500 23800; eva.schaeffer@uksh.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Human Nutrition, Kiel University

Model Details: Arm 1: Patients with prodromal PD receiving nutritional intervention Arm 2: Patients with clinical PD receiving nutritional intervention Arm 3: Patients with clinical PD receiving standard of care (control)

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 18, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)