The Effect of Gluten-free Diet on Clinical Symptoms, Immune Parameters and Metabolome in Neurodegenerative Diseases With Alfa-synucleinopathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- General University Hospital, Prague
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change in severity of the clinical symptoms
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
Hana Brozova
Head of the movement disorder section in GUH Prague
General University Hospital, Prague
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
Outcomes
Primary Outcomes
Change in severity of the clinical symptoms
Time Frame: Baseline, 1.5, 3, 6, 9, 12 and 13 months
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).
Secondary Outcomes
- Cognition change(Baseline, 1.5, 3, 6, 9, 12 and 13 months)
- Change in severity of the autonomic symptoms (Autonomic Scale for Outcomes in Parkinson's Disease)(Baseline, 1.5, 3, 6, 9, 12 and 13 months)
- Quality of sleep change(Baseline, 1.5, 3, 6, 9, 12 and 13 months)
- Change in spatio temporal parameters of the gait(Baseline, 1.5, 3, 6, 9, 12 and 13 months)
- Mood change(Baseline, 1.5, 3, 6, 9, 12 and 13 months)
- Change in quality of life(Baseline, 1.5, 3, 6, 9, 12 and 13 months)