G20.90 G20.91
Conditions
Interventions
Group 1: mixed diet group (meals ad libitum for 2 weeks)
Group 2: supplement group (meals ad libitum plus 15mg resistant starch type 3/day for 2 weeks and for further 48 weeks plus 10mg resistant star
Sponsors
Paracelsus-Elena-Klinik Kassel
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: -diagnosed Parkinson's disease according to UK Brain Bank Criteria -Hoehn and Yahr stage 1-4 -written informed consent in accordance with the Declaration of Helsinki
Exclusion criteria
Exclusion criteria: -known severe vascular encephalopathy or normal-pressure hydrocephalus as shown via MRI (when available at screening) -signs or symptoms according to multiple system atrophy or progressive supranuclear palsy -presence of suspicion of atypical PD or medication-induced PD -known intestinal pathologies -contraindication for longitudinal blood sampling -use of statins -use of probiotic, prebiotic or antibiotic products until 4 weeks prior to study entry patients on vegetarian/vegan diet until 4 weeks prio to study entry -pregnancy -unable to consent themselves
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Overall feasibility of dietary interventions for PD patients (measured after 2 weeks via drop-out rate and adverse event documentation) -Effects of the interventions on microbiome diversity and the associated metabolism (measured in stool samples over a period of 2 weeks, analysis of the microbial composition via 16S rRNA gene amplicon sequencing and of the metabolom via GC-MS and LC-MS/MS) -Effects of the interventions on inflammation (measured in blood samples after 1 week and after 2 weeks, analysis of the inflammasome via mass spectrometry) -Effects of the interventions on motor and non-motor symptoms (measured with clinical scales and questionnaires (MDS-UPDRS, NMSS, NMSQ) after 1 week and after 2 weeks) -Effects of the interventions on quality of life (measured with the questionnaire PDQ-39 after 1 week and after 2 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Effects of the intervention on disease progression (measured with the clinical scale MDS-UPDRS after 1 week, 2 weeks, and bimonthly for 48 weeks) -Effects of PD drugs and different meals on the primary outcome measures (measured with concomittant drug documentation and subject nutritional diaries) | — |
Countries
Germany
Contacts
Public ContactSebastian Schade
Paracelsus-Elena-Klinik Kassel
Outcome results
None listed