Ignite Creation Date:
2024-07-17 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-05
Brief Title:
Impact of Diet on the Microbiome-Immune-Brain Axis in Parkinsons Disease
Sponsor:
University of Kiel
Organization:
University of Kiel
Study Overview
Official Title:
Impact of Diet on the Microbiome-Immune-Brain Axis in Parkinsons Disease as Part of the Collaborative Research Center 1697 Targeting the Microbiome-Immune-Brain Interaction in Neurodegeneration
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons 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
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 eg dietary adherence gastrointestinal motility meal timing and frequency and factors associated with a high adherence eg 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 eg on sustainability and health effects and food literacy eg 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
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 eg dietary adherence gastrointestinal motility meal timing and frequency and factors associated with a high adherence eg 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 eg on sustainability and health effects and food literacy eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None