Parkinson DiseaseNCT06463769
Impact of Diet on the Microbiome-Immune-Brain Axis in Parkinson's Disease
A study testing 8 week predominantly plant-based New Nordic LPF-diet program and maintenance of the predominantly plant-based New Nordic LPF-diet in people with Parkinson Disease, run by University of Kiel at 2 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- 8 week predominantly plant-based New Nordic LPF-diet program and maintenance of the predominantly plant-based New Nordic LPF-diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesGermany
- Study dates
- May 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites
Institute of Human Nutrition
Kiel, 24105
Kiel University, University Hospital Schleswig-Holstein
Kiel, 24105
Eva Schäffer, MD, +49431 500 23800, eva.schaeffer@uksh.de
About this study
Official title: "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"
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.
Read the detailed description
In a pilot-intervention study, our project will:
- 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
- Parkinson Disease
- Being tested
- 8 week predominantly plant-based New Nordic LPF-diet program, maintenance of the predominantly plant-based New Nordic LPF-diet
- Keywords
- New Nordic Diet, Parkinson's Disease, Microbiome-Immune-Brain axis
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8 week predominantly plant-based New Nordic LPF-diet programBehavioural
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-dietBehavioural
Follow-up of long-term adherence to the diet at one and six months after completion of the intervention program.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
abundance of key SCFA-producing gut bacteria
analysis of stool samples
Measured: pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
Secondary outcomes (5)
systemic inflammation markers
hsCRP and IL-6 in serum
Measured: pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
metabolic resilience
modeling of one parameter (metabolic resilience) including information on postprandial glucose, insulin, triglycerides and NEFA following a mixed meal tolerance test
Measured: pre vs. post intervention (8 weeks)
gastrointestinal peptide-hormones
ghrelin, GLP-1, PYY
Measured: pre vs. post intervention (8 weeks)
energy balance
changes in body weight
Measured: pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
energy partitioning
changes in body composition
Measured: pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study startMay 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kiel
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Schleswig-Holstein
- Responsible party
- Principal investigator, Prof. Dr. Dr. Anja Bosy-Westphal, University of Kiel
- Investigators
- Anja Bosy-Westphal, PhD, MD, Principal investigator, University of KielEva Schäffer, MD, Principal investigator, Kiel University, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463769
- Sponsor's protocol ID
- CRC1697-C04
- Status last verified
- Apr 2026
- First submitted
- 5 Jun 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33557896Solch 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.
PubMed 35144237Maraki 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.
PubMed 30306634
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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"
- ClinicalTrials.gov ID
- NCT06463769
- Acronym / sponsor ID
- CRC1697-C04
- Conditions
- Parkinson Disease
- Keywords
- New Nordic Diet, Parkinson's Disease, Microbiome-Immune-Brain axis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of KielUniversity, hospital or other
- Collaborators
- University Hospital Schleswig-Holstein
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In a pilot-intervention study, our project will:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Patients with prodromal PD on New Nordic LPF-diet (intervention) | Experimental | Behavioral: 8 week predominantly plant-based New Nordic LPF-diet program, Behavioral: maintenance of the predominantly plant-based New Nordic LPF-dietPatients with prodromal 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 on New Nordic LPF-diet (intervention) | Experimental | Behavioral: 8 week predominantly plant-based New Nordic LPF-diet program, Behavioral: maintenance of the predominantly plant-based New Nordic LPF-dietPatients 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. |
| 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8 week predominantly plant-based New Nordic LPF-diet programAn 8-week patient-centered dietary intervention program will be implemented to maintain a predominantly plant-based New Nordic LPF-Diet. | Behavioural | 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-dietFollow-up of long-term adherence to the diet at one and six months after completion of the intervention program. | Behavioural | Patients with clinical PD on New Nordic LPF-diet (intervention), Patients with prodromal PD on New Nordic LPF-diet (intervention) |
Primary outcome
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
analysis of stool samples
5 secondary outcomes
systemic inflammation markers
Time frame: pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
metabolic resilience
Time frame: pre vs. post intervention (8 weeks)
gastrointestinal peptide-hormones
Time frame: pre vs. post intervention (8 weeks)
energy balance
Time frame: pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
energy partitioning
Time frame: pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 33557896Aho 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.
- Background: PubMed 35144237Solch 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.
- Background: PubMed 30306634Maraki 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anja Bosy-Westphal, PhD, MD principal investigator
University of Kiel
Eva Schäffer, MD principal investigator
Kiel University, University Hospital Schleswig-Holstein
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8 week predominantly plant-based New Nordic LPF-diet program and maintenance of the predominantly plant-based New Nordic LPF-diet in people with Parkinson Disease, run by University of Kiel at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anja Bosy-Westphal, PhD, MD (+494318805674, abosyw@nutrition.uni-kiel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06463769, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.