"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"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- abundance of key SCFA-producing gut bacteria
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 8 week predominantly plant-based New Nordic LPF-diet program (Behavioral)
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.
干预措施: maintenance of the predominantly plant-based New Nordic LPF-diet (Behavioral)
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.
干预措施: 8 week predominantly plant-based New Nordic LPF-diet program (Behavioral)
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.
干预措施: maintenance of the predominantly plant-based New Nordic LPF-diet (Behavioral)
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.
结局指标
主要结局
abundance of key SCFA-producing gut bacteria
时间窗: pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
analysis of stool samples
次要结局
- systemic inflammation markers(pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention)
- energy balance(pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention)
- metabolic resilience(pre vs. post intervention (8 weeks))
- gastrointestinal peptide-hormones(pre vs. post intervention (8 weeks))
- energy partitioning(pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention)
研究者
Prof. Dr. Dr. Anja Bosy-Westphal
Head of the Department of Human Nutrition, Kiel University
University of Kiel