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The Effect of Gluten-free Diet on Parkinsonism (GFREEPARK)

Primary Purpose

Parkinson Disease, Multiple System Atrophy, Non-celiac Gluten Sensitivity

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
gluten-free diet
Sponsored by
General University Hospital, Prague
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Multiple system atrophy, Gluten-free Diet

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GUHPragueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

PD gluten-free diet group

PD gluten-containing diet group

MSA gluten-free diet group

MSA gluten-containing diet group

Arm Description

Subjects with PD on gluten-free diet, ie. excluding all gluten-containing food during the day.

Subjects with PD on regular, gluten-containing diet, i.e. no restrictions during eating.

Subjects with PD on gluten-free diet, ie. excluding all gluten-containing food during the day.

Subjects with MSA on regular gluten-containing diet, i.e. no restrictions during eating.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Cognition change
Scored by Montreal Cognitive Assessment (scores ranging from 0 to 30, lower scores indicate greater impairment).
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).
Change in spatio temporal parameters of the gait
Investigated by GaitRite system
Quality of sleep change
Scored by Pittsburgh Sleep Quality Index
Mood change
Scored by Beck depression inventory (scores ranging from 0 to 63, higher scores indicate greater impairment).
Change in quality of life
Scored by Quality of life questionnaire (scores ranging from 0 to 100, higher scores indicate greater impairment).

Full Information

First Posted
February 3, 2022
Last Updated
March 30, 2022
Sponsor
General University Hospital, Prague
Collaborators
Czech Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05238545
Brief Title
The Effect of Gluten-free Diet on Parkinsonism
Acronym
GFREEPARK
Official Title
The Effect of Gluten-free Diet on Clinical Symptoms, Immune Parameters and Metabolome in Neurodegenerative Diseases With Alfa-synucleinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General University Hospital, Prague
Collaborators
Czech Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Multiple System Atrophy, Non-celiac Gluten Sensitivity
Keywords
Parkinson Disease, Multiple system atrophy, Gluten-free Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PD gluten-free diet group
Arm Type
Experimental
Arm Description
Subjects with PD on gluten-free diet, ie. excluding all gluten-containing food during the day.
Arm Title
PD gluten-containing diet group
Arm Type
No Intervention
Arm Description
Subjects with PD on regular, gluten-containing diet, i.e. no restrictions during eating.
Arm Title
MSA gluten-free diet group
Arm Type
Experimental
Arm Description
Subjects with PD on gluten-free diet, ie. excluding all gluten-containing food during the day.
Arm Title
MSA gluten-containing diet group
Arm Type
No Intervention
Arm Description
Subjects with MSA on regular gluten-containing diet, i.e. no restrictions during eating.
Intervention Type
Other
Intervention Name(s)
gluten-free diet
Intervention Description
Diet excluding foods containing gluten.
Primary Outcome Measure Information:
Title
Change in severity of the clinical symptoms
Description
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).
Time Frame
Baseline, 1.5, 3, 6, 9, 12 and 13 months
Secondary Outcome Measure Information:
Title
Cognition change
Description
Scored by Montreal Cognitive Assessment (scores ranging from 0 to 30, lower scores indicate greater impairment).
Time Frame
Baseline, 1.5, 3, 6, 9, 12 and 13 months
Title
Change in severity of the autonomic symptoms (Autonomic Scale for Outcomes in Parkinson's Disease)
Description
Scored by Autonomic Scale for Outcomes in Parkinson's Disease (scores ranging from 0 to 69, higher scores indicate greater impairment).
Time Frame
Baseline, 1.5, 3, 6, 9, 12 and 13 months
Title
Change in spatio temporal parameters of the gait
Description
Investigated by GaitRite system
Time Frame
Baseline, 1.5, 3, 6, 9, 12 and 13 months
Title
Quality of sleep change
Description
Scored by Pittsburgh Sleep Quality Index
Time Frame
Baseline, 1.5, 3, 6, 9, 12 and 13 months
Title
Mood change
Description
Scored by Beck depression inventory (scores ranging from 0 to 63, higher scores indicate greater impairment).
Time Frame
Baseline, 1.5, 3, 6, 9, 12 and 13 months
Title
Change in quality of life
Description
Scored by Quality of life questionnaire (scores ranging from 0 to 100, higher scores indicate greater impairment).
Time Frame
Baseline, 1.5, 3, 6, 9, 12 and 13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hana Brožová, MD, PhD
Phone
224965539
Ext
00420
Email
hana.brozova@lf1.cuni.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Kamila Poláková, MD, PhD
Phone
224965539
Ext
00420
Email
kamila.polakova@vfn.cz
Facility Information:
Facility Name
GUHPrague
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hana Brožová, MD
Phone
224965539
Ext
00420
Email
hana.brozova@lf1.cuni.cz

12. IPD Sharing Statement

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The Effect of Gluten-free Diet on Parkinsonism

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