NCT05238545: GFREEPARK

The Effect of Gluten-free Diet on Parkinsonism

Status unknown NA Last updated 8 April 2022

What this trial tests

NA trial testing gluten-free diet in Parkinson Disease in 90 participants. Status unknown.

Timeline

1 October 2021

Primary endpoint
31 December 2024

31 December 2025

Quick facts

Lead sponsor	General University Hospital, Prague
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	90
Start date	1 October 2021
Primary completion	31 December 2024
Estimated completion	31 December 2025
Sites	1 location across Czechia

Drugs / interventions tested

• gluten-free diet

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →
• Multiple System Atrophy — all drugs for Multiple System Atrophy →
• Non-celiac Gluten Sensitivity — all drugs for Non-celiac Gluten Sensitivity →

Sponsor

General University Hospital, Prague

Who can join

Adults 40 to 80, any sex, with Parkinson Disease or Multiple System Atrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut-brain axis: gut dysbiosis and psychiatric disorders in Alzheimer's and Parkinson's disease.
   Denman CR, Park SM, Jo J. · · 2023 · cited 20× · PMID 38075261 · DOI 10.3389/fnins.2023.1268419
2. Dietary Interventions in Parkinson's Disease.
   van der Berg I, Schootemeijer S, Overbeek K, Bloem BR, et al · · 2024 · cited 18× · PMID 38277304 · DOI 10.3233/jpd-230366