Parkinson Disease Clinical Trial
Official title:
The Effect of Gluten-free Diet on Clinical Symptoms, Immune Parameters and Metabolome in Neurodegenerative Diseases With Alfa-synucleinopathy
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05415774 -
Combined Deep Brain Stimulation in Parkinson's Disease
|
N/A | |
Recruiting |
NCT04691661 -
Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease
|
Phase 2 | |
Active, not recruiting |
NCT05754086 -
A Multidimensional Study on Articulation Deficits in Parkinsons Disease
|
||
Completed |
NCT04045925 -
Feasibility Study of the Taïso Practice in Parkinson's Disease
|
N/A | |
Recruiting |
NCT04194762 -
PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation
|
N/A | |
Completed |
NCT02705755 -
TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)
|
Phase 2 | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Recruiting |
NCT05830253 -
Free-living Monitoring of Parkinson's Disease Using Smart Objects
|
||
Recruiting |
NCT03272230 -
Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System
|
N/A | |
Recruiting |
NCT06139965 -
Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
|
||
Completed |
NCT04580849 -
Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease
|
N/A | |
Completed |
NCT04477161 -
Effect of Ketone Esters in Parkinson's Disease
|
N/A | |
Completed |
NCT03980418 -
Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam
|
N/A | |
Completed |
NCT04942392 -
Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic
|
N/A | |
Terminated |
NCT03446833 -
LFP Beta aDBS Feasibility Study
|
N/A | |
Completed |
NCT03497884 -
Individualized Precise Localization of rTMS on Primary Motor Area
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Recruiting |
NCT04997642 -
Parkinson's Disease and Movement Disorders Clinical Database
|
||
Completed |
NCT04117737 -
A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
|
N/A | |
Recruiting |
NCT03618901 -
Rock Steady Boxing vs. Sensory Attention Focused Exercise
|
N/A |