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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorUniversity of Kiel

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Patients with prodromal PD on New Nordic LPF-diet (intervention)Experimental treatment 2 interventions
Group B: Patients with clinical PD on New Nordic LPF-diet (intervention)Experimental treatment 2 interventions
Group C: Patients with clinical PD receiving standard of care (control)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

abundance of key SCFA-producing gut bacteria

analysis of stool samples

Time frame
pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention

Secondary outcomes

1

systemic inflammation markers

hsCRP and IL-6 in serum

Time frame
pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
2

metabolic resilience

modeling of one parameter (metabolic resilience) including information on postprandial glucose, insulin, triglycerides and NEFA following a mixed meal tolerance test

Time frame
pre vs. post intervention (8 weeks)
3

gastrointestinal peptide-hormones

ghrelin, GLP-1, PYY

Time frame
pre vs. post intervention (8 weeks)
4

energy balance

changes in body weight

Time frame
pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention

Other outcomes

1

clinical motor symptoms

clinical examination

Time frame
pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
2

clinical non-motor symptoms

clinical examination

Time frame
pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
3

gastric emptying

13C-breath test

Time frame
pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention
4

gastrointestinal transit time

using a test meal with food colouring and the time to colour appearance in stool

Time frame
pre vs. post intervention (8 weeks) + pre intervention vs. follow-up 6 months after completion of intervention

Sponsors and contacts

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University of Kiel

Lead sponsor

University Hospital Schleswig-Holstein

Collaborator

This trial is not recruiting at the moment. You can still explore other options: