The Effect of Gluten-free Diet on Clinical Symptoms, Immune Parameters and Metabolome in Neurodegenerative Diseases With Alfa-synucleinopathy

Status: Recruiting
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Recent data suggest that the brain-gut axis, chronic intestinal inflammation and microbiome may contribute to the pathogenesis of neurodegenerative diseases with alfa-synucleinopathy, which include Parkinson's disease (PD) and Multiple system atrophy (MSA). Environmental factors e.g. diets, microbiome, metabolites and immune mechanisms may play important role in pathogenesis of these diseases. In the human arm of this project, the investigators will address effects of an anti-inflammatory gluten-free diet (GFD) on motor and non-motor symptoms as well as its effects on immune and metabolomic characteristics in patients with PD and MSA. In the mouse arm, the investigations will focus on the effects of GFD in chronic MPTP-induced mouse model of PD in various settings (e.g. in young or aged animals, with respect to the lengths of exposure to GFD). The chronic MPTP model will be used to assess the effects of GFD on adaptive and immune characteristics, and metabolic signatures. Using germ-free animals, the microbiome-dependency of the GFD-mediated effects may be determined. The anti-inflammatory gluten-free diet and its related mechanisms represent novel, promising and relatively straightforward approach in a search to improve symptoms of PD as well as MSA or even in their prevention.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• subjects with establish diagnosis of PD in clinical stage 2-4 of Hoehn\&Yahr scale or with establish diagnosis of MSA

• stable treatment for \>4 weeks

• willing and able to give informed consent for participation in the study

• male and female subjects, aged 40 years or older

• able to understand and willing to comply with study procedures

• willing to avoid any other diet restrictions

• BMI 18-30

Contact Information
Primary
Hana Brožová, MD, PhD
hana.brozova@lf1.cuni.cz
224965539
Backup
Kamila Poláková, MD, PhD
kamila.polakova@vfn.cz
224965539
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 90
Treatments
Experimental: PD gluten-free diet group
Subjects with PD on gluten-free diet, ie. excluding all gluten-containing food during the day.
No_intervention: PD gluten-containing diet group
Subjects with PD on regular, gluten-containing diet, i.e. no restrictions during eating.
Experimental: MSA gluten-free diet group
Subjects with PD on gluten-free diet, ie. excluding all gluten-containing food during the day.
No_intervention: MSA gluten-containing diet group
Subjects with MSA on regular gluten-containing diet, i.e. no restrictions during eating.
Sponsors
Collaborators: Czech Academy of Sciences
Leads: General University Hospital, Prague

This content was sourced from clinicaltrials.gov