The Effect of Gluten-free Diet on Parkinsonism

NCT ID: NCT05238545

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

This project is based on two research lines, testing the effect of gluten-free diet in a patients with PD and MSA (a human prospective trial) and in the chronic MPTP (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine)-induced mouse model of PD.

Research line 1. Assessments of effects of gluten-free diet (GFD) on clinical symptoms of Parkinson's disease (PD) and multiple system atrophy (MSA) in a prospective, controlled, randomized, rater-blinded human study. The goal of the research line 1 is to assess the effects of 12 months of administration of GFD on clinical symptoms of PD and MSA.

Research line 2. Effects of GFD on the development of PD in the chronic MPTP-induced mouse model of PD. The goal of the research line 2 is to study the effects of GFD in the chronic MPTP-induced mouse model of PD in order to evaluate its impact on clinical development of PD's features as well as immune and metabolomic characteristics that should shed more light on the possible mechanisms and potential novel treatment opportunities.

Conditions

Parkinson Disease; Multiple System Atrophy; Non-celiac Gluten Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PD gluten-free diet group

Subjects with PD on gluten-free diet, ie. excluding all gluten-containing food during the day.

Group Type: EXPERIMENTAL

gluten-free diet

Intervention Type: OTHER

Diet excluding foods containing gluten.

PD gluten-containing diet group

Subjects with PD on regular, gluten-containing diet, i.e. no restrictions during eating.

Group Type: NO_INTERVENTION

No interventions assigned to this group

MSA gluten-free diet group

Subjects with PD on gluten-free diet, ie. excluding all gluten-containing food during the day.

Group Type: EXPERIMENTAL

gluten-free diet

Intervention Type: OTHER

Diet excluding foods containing gluten.

MSA gluten-containing diet group

Subjects with MSA on regular gluten-containing diet, i.e. no restrictions during eating.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

gluten-free diet

Diet excluding foods containing gluten.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• concomitant neurological, gastrointestinal or immunological disease
• diet restriction
• dementia affecting compliance
• acute psychiatric symptoms

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Czech Academy of Sciences

OTHER

Sponsor Role: collaborator

General University Hospital, Prague

OTHER

Sponsor Role: lead

Responsible Party

Hana Brozova

Head of the movement disorder section in GUH Prague

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

GUHPrague

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Hana Brožová, MD, PhD

Role: CONTACT

hana.brozova@lf1.cuni.cz

224965539 ext. 00420

Kamila Poláková, MD, PhD

Role: CONTACT

kamila.polakova@vfn.cz

224965539 ext. 00420

Facility Contacts

Hana Brožová, MD

Role: primary

hana.brozova@lf1.cuni.cz

224965539 ext. 00420

Other Identifiers

NU21-04-00443

Identifier Type: -

Identifier Source: org_study_id