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

Parkinson Disease Clinical Trial

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"

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06463769
• Other study ID #: CRC1697-C04
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2025
• Est. completion date: July 2028

Study information

• Verified date: June 2024
• Source: University of Kiel
• Contact: Anja Bosy-Westphal, PhD, MD
• Phone: +494318805674
• Email: abosyw[@]nutrition.uni-kiel.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: July 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Germany	Institute of Human Nutrition	Kiel
Germany	Kiel University, University Hospital Schleswig-Holstein	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
University of Kiel	University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	clinical motor symptoms	clinical examination	pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
Other	clinical non-motor symptoms	clinical examination	pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
Other	gastric emptying	13C-breath test	pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
Other	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
Other	gut motility	functional visceral MRI	pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	metabolic resilience	modeling of one parameter (metabolic resilience) including information on postprandial glucose, insulin, triglycerides and NEFA following a mixed meal tolerance test	pre vs. post intervention (8 weeks)
Secondary	gastrointestinal peptide-hormones	ghrelin, GLP-1, PYY	pre vs. post intervention (8 weeks)
Secondary	energy balance	changes in body weight	pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
Secondary	energy partitioning	changes in body composition	pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention