Impact of Diet on the Microbiome-Immune-Brain Axis in Parkinson's Disease
NCT ID: NCT06463769
Last Updated: 2024-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
75 participants
INTERVENTIONAL
2025-05-31
2028-07-31
Brief Summary
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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.
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Detailed Description
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* develop a practical, low-threshold diet intervention for patients with prodromal and clinical PD. Adherence will be promoted (i) by a patient-oriented approach, (ii) by implementation of the predominantly plant-based New Nordic LPF-diet that is scientifically-based, culturally adapted, sustainable and culinary and (iii) by an innovative web-application.
* investigate the acute effects of the predominantly plant-based New Nordic LPF -diet on the microbiome (abundance of SCFA-producing bacteria), gastrointestinal motility, inflammation as well as metabolic and Parkinson-specific clinical outcomes in individuals with prodromal and clinical PD.
* investigate potential determinants of long-term changes in the gut microbiome (e.g. dietary adherence, gastrointestinal motility, meal timing and frequency), and factors associated with a high adherence (e.g. acceptance of diet as therapeutic intervention in the prodromal phase, health-related quality of life).
The patient-centered intervention program will be tailored to individual needs and preferences of individuals with prodromal and clinical PD. It will be designed to impart knowledge (e.g. on sustainability and health effects) and food literacy (e.g. food merchandize and culinary skills) in group meetings and culinary medicine workshops. Recipe suggestions and shopping guides will consider individual abilities and needs and a web-application is used for information, increasing self-efficacy, motivation, and monitoring. To ensure an easy integration of the diet into everyday life, partners will be included in the program, if applicable. Moreover, cultural preferences as well as financial resources will be considered. Regular feedback using statistics on nutrient intake and overall progress will be implemented to encourage adherence.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion 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)
Exclusion Criteria
* 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
50 Years
80 Years
ALL
No
Sponsors
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University Hospital Schleswig-Holstein
OTHER
University of Kiel
OTHER
Responsible Party
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Prof. Dr. Dr. Anja Bosy-Westphal
Head of the Department of Human Nutrition, Kiel University
Principal Investigators
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Anja Bosy-Westphal, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Kiel University
Eva Schäffer, MD
Role: PRINCIPAL_INVESTIGATOR
Kiel University, University Hospital Schleswig-Holstein
Locations
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Institute of Human Nutrition
Kiel, , Germany
Kiel University, University Hospital Schleswig-Holstein
Kiel, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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CRC1697-C04
Identifier Type: -
Identifier Source: org_study_id
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