Effects of a gluten-free diet on Parkinson's disease and multiple system atrophy
The Effect of Gluten-free Diet on Clinical Symptoms, Immune Parameters and Metabolome in Neurodegenerative Diseases With Alfa-synucleinopathy
NA · General University Hospital, Prague · NCT05238545
This study is testing whether a gluten-free diet can help people with Parkinson's disease and multiple system atrophy feel better over a year.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | General University Hospital, Prague (other) |
| Locations | 1 site (Prague) |
| Trial ID | NCT05238545 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a gluten-free diet (GFD) on patients with Parkinson's disease (PD) and multiple system atrophy (MSA). It includes a human prospective trial assessing clinical symptoms over 12 months, alongside a mouse model study to explore immune and metabolic changes. The aim is to understand how dietary changes may influence neurodegenerative disease progression and symptoms. The study will be conducted at the General University Hospital in Prague, collaborating with the Czech Academy of Sciences.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older with a confirmed diagnosis of PD (stages 2-4) or MSA, who can comply with study protocols.
Not a fit: Patients with concurrent neurological, gastrointestinal, or immunological diseases, or those with acute psychiatric symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new dietary management strategies to improve symptoms and quality of life for patients with PD and MSA.
How similar studies have performed: While the approach of dietary intervention in neurodegenerative diseases is gaining interest, this specific study's focus on a gluten-free diet is relatively novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Prague
- GUHPrague — Prague, Czechia (RECRUITING)
Study contacts
- Study coordinator: Hana Brožová, MD, PhD
- Email: hana.brozova@lf1.cuni.cz
- Phone: 224965539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson Disease, Multiple System Atrophy, Non-celiac Gluten Sensitivity, Multiple system atrophy, Gluten-free Diet