Single-center Study of Gustation in Idiopathic Parkinson's Disease and Lewy Body Disease Using Gustatory Evoked Potential Analysis
NCT ID: NCT06439355
Last Updated: 2024-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2024-05-27
2026-05-31
Brief Summary
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* healthy volunteers
* patients with early Parkinson's disease
* patients with incipient Lewy body disease.
To this end, the results obtained from taste evoked potentials in each of the 3 groups of participants will be compared with each other and with different nutritional, motor and cognitive data.
This study could reveal a difference in cortical processing of gustatory sensory information between patients who have had idiopathic Parkinson's disease progressing for 3 years or less, and patients who have had Lewy body disease progressing for 3 years or less. Indeed, a modification of taste evoked potentials (in terms of latencies) proportional to the degree of cerebral degeneration could be observed.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Healthy volunteers
Fasting blood test
metabolic assays determination of food intake hormones oxidative stress and neurodegeneration marker assays
Subject interview
socio-demographic data, medical and family history, treatment taken
Motor assessment
MDS-UPDRS scale PART III
Neurocognitive assessment
MoCA and MMSE scales
Nutritional assessment
anthropometric data (weight, height, BMI, waist circumference, hip circumference, android/gynoid ratio, triceps skin fold, brachial circumference), bioelectrical impedancemetry (fat mass, lean mass, water mass and bone mass)
Taste tests
Recording of PEGs in response to a sucrose solution and a free fatty acid solution (prepared beforehand)
Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years
Fasting blood test
metabolic assays determination of food intake hormones oxidative stress and neurodegeneration marker assays
Subject interview
socio-demographic data, medical and family history, treatment taken
Motor assessment
MDS-UPDRS scale PART III
Neurocognitive assessment
MoCA and MMSE scales
Nutritional assessment
anthropometric data (weight, height, BMI, waist circumference, hip circumference, android/gynoid ratio, triceps skin fold, brachial circumference), bioelectrical impedancemetry (fat mass, lean mass, water mass and bone mass)
Taste tests
Recording of PEGs in response to a sucrose solution and a free fatty acid solution (prepared beforehand)
Patients with Lewy body disease (LBD) progressing ≤ 3 years
Fasting blood test
metabolic assays determination of food intake hormones oxidative stress and neurodegeneration marker assays
Subject interview
socio-demographic data, medical and family history, treatment taken
Motor assessment
MDS-UPDRS scale PART III
Neurocognitive assessment
MoCA and MMSE scales
Nutritional assessment
anthropometric data (weight, height, BMI, waist circumference, hip circumference, android/gynoid ratio, triceps skin fold, brachial circumference), bioelectrical impedancemetry (fat mass, lean mass, water mass and bone mass)
Taste tests
Recording of PEGs in response to a sucrose solution and a free fatty acid solution (prepared beforehand)
Interventions
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Fasting blood test
metabolic assays determination of food intake hormones oxidative stress and neurodegeneration marker assays
Subject interview
socio-demographic data, medical and family history, treatment taken
Motor assessment
MDS-UPDRS scale PART III
Neurocognitive assessment
MoCA and MMSE scales
Nutritional assessment
anthropometric data (weight, height, BMI, waist circumference, hip circumference, android/gynoid ratio, triceps skin fold, brachial circumference), bioelectrical impedancemetry (fat mass, lean mass, water mass and bone mass)
Taste tests
Recording of PEGs in response to a sucrose solution and a free fatty acid solution (prepared beforehand)
Eligibility Criteria
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Inclusion Criteria
* Person who has given written consent
* Adult
* Enrolled in the national register of healthy volunteers
* Fasting \> 2 hours before PEG measurement
* Body Mass Index (BMI) \< 30 kg/m².
* No cognitive complaints and normal neurological assessment
Patients with idiopathic Parkinson's disease:
* Person who has given written consent
* Adult
* Fasting \> 2 hours before PEG measurement
* Body Mass Index (BMI) \< 30 kg/m².
* Diagnostic criteria for established or probable IPD
Patients with Lewy body disease:
* Person who has given written consent
* Adult
* Fasting \> 2 hours prior to PEG measurement
* Body Mass Index (BMI) \< 30 kg/m².
* Diagnostic criteria for probable or possible LBD
Exclusion Criteria
* Person under legal protection (curatorship, guardianship)
* Person subject to a court order
* Pregnant, parturient or breast-feeding women
* Major unable to give consent
* MMSE score \< 15 and/or MoCA \< 10
* Known infection with COVID-19 in the 6 months prior to inclusion
* Active smoker (\> 4 cigarettes per day on a regular basis)
* Subject with pacemaker (contraindication for bioelectrical impedancemetry)
* Diabetic (type 1 or type 2)
* Taking medication (in progress at the time of the study) that interferes with gustation
18 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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Chu Dijon Bourgogne
Dijon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SCHNEIDER J'InvEST-I 2023
Identifier Type: -
Identifier Source: org_study_id
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