The Effect of Gluten-free Diet on Parkinsonism

NCT05238545 | Unknown

• 1 other identifier: NU21-04-00443
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Parkinson Disease; Multiple system atrophy; Gluten-free Diet

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, 1.5, 3, 6, 9, 12 and 13 months

Secondary Outcomes (6)

• Cognition change

  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)

  Baseline, 1.5, 3, 6, 9, 12 and 13 months

• Change in spatio temporal parameters of the gait

  Baseline, 1.5, 3, 6, 9, 12 and 13 months

• Quality of sleep change

  Baseline, 1.5, 3, 6, 9, 12 and 13 months

• Mood change

  Baseline, 1.5, 3, 6, 9, 12 and 13 months

Study Arms (4)

PD gluten-free diet group

EXPERIMENTAL

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

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.

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.

Interventions

gluten-free diet OTHER

Diet excluding foods containing gluten.

MSA gluten-free diet group; PD gluten-free diet group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• concomitant neurological, gastrointestinal or immunological disease
• diet restriction
• dementia affecting compliance
• acute psychiatric symptoms

Sponsors & Collaborators

• General University Hospital, Prague: lead
• Czech Academy of Sciences: collaborator

Study Sites (1)

GUHPrague

Prague, Czechia

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Hana Brožová, MD, PhD

CONTACT

224965539; hana.brozova@lf1.cuni.cz

Kamila Poláková, MD, PhD

CONTACT

224965539; kamila.polakova@vfn.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the movement disorder section in GUH Prague

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: October 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 8, 2022

Record last verified: 2022-03

Locations

CZ (1)