Parkinson DiseaseGFREEPARKNCT05238545
The Effect of Gluten-free Diet on Parkinsonism
A study testing gluten-free diet in people with Parkinson Disease and Multiple System Atrophy, run by General University Hospital, Prague at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease, Multiple System Atrophy, Non-celiac Gluten Sensitivity
- What is being tested?
- gluten-free diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Oct 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- concomitant neurological, gastrointestinal or immunological disease
- diet restriction
- dementia affecting compliance
- acute psychiatric symptoms
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
GUHPrague
Prague
Hana Brožová, MD, 224965539 ext. 00420, hana.brozova@lf1.cuni.cz
About this study
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.
Read the 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.
- Being tested
- gluten-free diet
- Keywords
- Parkinson Disease, Multiple system atrophy, Gluten-free Diet
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gluten-free dietOther
Diet excluding foods containing gluten.
| Study group | Role | What they receive |
|---|---|---|
| PD gluten-free diet group | Experimental | Subjects with PD on gluten-free diet, ie. excluding all gluten-containing food during the day. Receives: Other: gluten-free diet |
| PD gluten-containing diet group | No intervention | Subjects with PD on regular, gluten-containing diet, i.e. no restrictions during eating. |
| MSA gluten-free diet group | Experimental | Subjects with PD on gluten-free diet, ie. excluding all gluten-containing food during the day. Receives: Other: gluten-free diet |
| MSA gluten-containing diet group | No intervention | Subjects with MSA on regular gluten-containing diet, i.e. no restrictions during eating. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 1.5, 3, 6, 9, 12 and 13 months
Secondary outcomes (6)
Cognition change
Scored by Montreal Cognitive Assessment (scores ranging from 0 to 30, lower scores indicate greater impairment).
Measured: 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)
Scored by Autonomic Scale for Outcomes in Parkinson's Disease (scores ranging from 0 to 69, higher scores indicate greater impairment).
Measured: Baseline, 1.5, 3, 6, 9, 12 and 13 months
Change in spatio temporal parameters of the gait
Investigated by GaitRite system
Measured: Baseline, 1.5, 3, 6, 9, 12 and 13 months
Quality of sleep change
Scored by Pittsburgh Sleep Quality Index
Measured: Baseline, 1.5, 3, 6, 9, 12 and 13 months
Mood change
Scored by Beck depression inventory (scores ranging from 0 to 63, higher scores indicate greater impairment).
Measured: Baseline, 1.5, 3, 6, 9, 12 and 13 months
Change in quality of life
Scored by Quality of life questionnaire (scores ranging from 0 to 100, higher scores indicate greater impairment).
Measured: Baseline, 1.5, 3, 6, 9, 12 and 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Oct 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study groups in PD and MSA group with gluten-free diet and on regular gluten-containing diet. Randomization: patients will be randomized by diagnosis, age and disease duration, a numbered envelope in 1:1 ration to gluten-free diet group and regular gluten-containing diet group will be used.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Czech Academy of Sciences
- Responsible party
- Principal investigator, Hana Brozova, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238545
- Sponsor's protocol ID
- NU21-04-00443
- Acronym
- GFREEPARK
- Status last verified
- Mar 2022
- First submitted
- 3 Feb 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gluten-free Diet on Clinical Symptoms, Immune Parameters and Metabolome in Neurodegenerative Diseases With Alfa-synucleinopathy
- ClinicalTrials.gov ID
- NCT05238545
- Acronym / sponsor ID
- GFREEPARK / NU21-04-00443
- Keywords
- Parkinson Disease, Multiple system atrophy, Gluten-free Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Collaborators
- Czech Academy of Sciences
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Study groups in PD and MSA group with gluten-free diet and on regular gluten-containing diet. Randomization: patients will be randomized by diagnosis, age and disease duration, a numbered envelope in 1:1 ration to gluten-free diet group and regular gluten-containing diet group will be used.
| Arm | Type | Receives |
|---|---|---|
| PD gluten-free diet group | Experimental | Other: gluten-free dietSubjects with PD on gluten-free diet, ie. excluding all gluten-containing food during the day. |
| PD gluten-containing diet group | No intervention | –Subjects with PD on regular, gluten-containing diet, i.e. no restrictions during eating. |
| MSA gluten-free diet group | Experimental | Other: gluten-free dietSubjects with PD on gluten-free diet, ie. excluding all gluten-containing food during the day. |
| MSA gluten-containing diet group | No intervention | –Subjects with MSA on regular gluten-containing diet, i.e. no restrictions during eating. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- concomitant neurological, gastrointestinal or immunological disease
- diet restriction
- dementia affecting compliance
- acute psychiatric symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gluten-free dietDiet excluding foods containing gluten. | Other | MSA gluten-free diet group, PD gluten-free diet group |
Primary outcome
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).
6 secondary outcomes
Cognition change
Time frame: 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)
Time frame: Baseline, 1.5, 3, 6, 9, 12 and 13 months
Change in spatio temporal parameters of the gait
Time frame: Baseline, 1.5, 3, 6, 9, 12 and 13 months
Quality of sleep change
Time frame: Baseline, 1.5, 3, 6, 9, 12 and 13 months
Mood change
Time frame: Baseline, 1.5, 3, 6, 9, 12 and 13 months
Change in quality of life
Time frame: Baseline, 1.5, 3, 6, 9, 12 and 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gluten-free diet in people with Parkinson Disease and Multiple System Atrophy, run by General University Hospital, Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hana Brožová, MD, PhD (224965539 ext. 00420, hana.brozova@lf1.cuni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in severity of the clinical symptoms (time frame: Baseline, 1.5, 3, 6, 9, 12 and 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.