About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
8 week predominantly plant-based New Nordic LPF-diet program
BehavioralAn 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
BehavioralFollow-up of long-term adherence to the diet at one and six months after completion of the intervention program.
Treatment groups
Trial outcomes
Primary outcomes
abundance of key SCFA-producing gut bacteria
analysis of stool samples
Secondary outcomes
systemic inflammation markers
hsCRP and IL-6 in serum
metabolic resilience
modeling of one parameter (metabolic resilience) including information on postprandial glucose, insulin, triglycerides and NEFA following a mixed meal tolerance test
gastrointestinal peptide-hormones
ghrelin, GLP-1, PYY
energy balance
changes in body weight
Other outcomes
clinical motor symptoms
clinical examination
clinical non-motor symptoms
clinical examination
gastric emptying
13C-breath test
gastrointestinal transit time
using a test meal with food colouring and the time to colour appearance in stool
Sponsors and contacts
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University of Kiel
Lead sponsor
University Hospital Schleswig-Holstein
Collaborator
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