Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital Schleswig-Holstein | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
In a pilot-intervention study, our project will:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| systemic inflammation markers | hsCRP and IL-6 in serum | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| clinical motor symptoms | clinical examination | pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention |
| clinical non-motor symptoms | clinical examination |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anja Bosy-Westphal, PhD, MD | Contact | +494318805674 | abosyw@nutrition.uni-kiel.de | |
| Eva Schäffer, MD | Contact | +49431 500 23800 | eva.schaeffer@uksh.de |
| Name | Affiliation | Role |
|---|---|---|
| Anja Bosy-Westphal, PhD, MD | University of Kiel | Principal Investigator |
| Eva Schäffer, MD | Kiel University, University Hospital Schleswig-Holstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Human Nutrition | Kiel | 24105 | Germany | |||
| Kiel University, University Hospital Schleswig-Holstein |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33557896 | Background | 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. | |
| 35144237 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| pre vs. post intervention (8 weeks) |
| gastrointestinal peptide-hormones | ghrelin, GLP-1, PYY | pre vs. post intervention (8 weeks) |
| energy balance | changes in body weight | pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention |
| energy partitioning | changes in body composition | pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention |
| pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention |
| gastric emptying | 13C-breath test | pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention |
| gastrointestinal transit time | using a test meal with food colouring and the time to colour appearance in stool | pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention |
| gut motility | functional visceral MRI | pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention |
| dietary adherence via serum markers | serum carotinoid and Trimethylamine oxid-levels will be combined and tertiles will be formed | pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention |
| dietary adherence via healthy Nordic food Index | healthy Nordic food Index using data from a food frequency questionnaire | pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention |
| food literacy effectiveness | self-perceived food literacy scale (questionnaire) | pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention |
| patient acceptance | Parkinson's Disease Questionnaire (PDQ-39) | pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention |
| patient quality of life | Ways of Coping Questionnaire (WCQ) | pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention |
| Kiel |
| 24105 |
| Germany |
|
| 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. |
| 30306634 | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |