The Effect of Gluten-free Diet on Parkinsonism

Parkinson Disease Clinical Trial

— GFREEPARK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05238545
• Other study ID #: NU21-04-00443
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2022
• Source: General University Hospital, Prague
• Contact: Hana Brožová, MD, PhD
• Phone: 224965539
• Email: hana.brozova[@]lf1.cuni.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Non-celiac Gluten Sensitivity
• Parkinson Disease
• Shy-Drager Syndrome

Intervention

Other:
• gluten-free diet
Diet excluding foods containing gluten.

Locations

Country	Name	City	State
Czechia	GUHPrague	Prague

Sponsors (2)

Lead Sponsor	Collaborator
General University Hospital, Prague	Czech Academy of Sciences

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in severity of the clinical symptoms	Scored by the MDS-Unified Parkinson's Disease Rating Scale (scores ranging from 0 to 260, higher scores indicate greater impairment) or Unified Multiple System Atrophy Rating Scale (scores ranging from 0 to 104, higher scores indicate greater impairment).	Baseline, 1.5, 3, 6, 9, 12 and 13 months
Secondary	Cognition change	Scored by Montreal Cognitive Assessment (scores ranging from 0 to 30, lower scores indicate greater impairment).	Baseline, 1.5, 3, 6, 9, 12 and 13 months
Secondary	Change in severity of the autonomic symptoms (Autonomic Scale for Outcomes in Parkinson's Disease)	Scored by Autonomic Scale for Outcomes in Parkinson's Disease (scores ranging from 0 to 69, higher scores indicate greater impairment).	Baseline, 1.5, 3, 6, 9, 12 and 13 months
Secondary	Change in spatio temporal parameters of the gait	Investigated by GaitRite system	Baseline, 1.5, 3, 6, 9, 12 and 13 months
Secondary	Quality of sleep change	Scored by Pittsburgh Sleep Quality Index	Baseline, 1.5, 3, 6, 9, 12 and 13 months
Secondary	Mood change	Scored by Beck depression inventory (scores ranging from 0 to 63, higher scores indicate greater impairment).	Baseline, 1.5, 3, 6, 9, 12 and 13 months
Secondary	Change in quality of life	Scored by Quality of life questionnaire (scores ranging from 0 to 100, higher scores indicate greater impairment).	Baseline, 1.5, 3, 6, 9, 12 and 13 months