Single-center Study of Gustation in Idiopathic Parkinson's Disease and Lewy Body Disease Using Gustatory Evoked Potential Analysis (PI-PEG)

June 6, 2024 updated by: Centre Hospitalier Universitaire Dijon

The aim of the PI-PEG study is to explore the taste functions of the following 3 groups of participants:

  • 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Healthy volunteers:

  • 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:

  • Non-affiliated to national health insurance
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy volunteers
Biological: Fasting blood test
metabolic assays determination of food intake hormones oxidative stress and neurodegeneration marker assays
Other: Subject interview
socio-demographic data, medical and family history, treatment taken
Other: Motor assessment
MDS-UPDRS scale PART III
Other: Neurocognitive assessment
MoCA and MMSE scales
Other: 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)
Other: Taste tests
Recording of PEGs in response to a sucrose solution and a free fatty acid solution (prepared beforehand)
Experimental: Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years
Biological: Fasting blood test
metabolic assays determination of food intake hormones oxidative stress and neurodegeneration marker assays
Other: Subject interview
socio-demographic data, medical and family history, treatment taken
Other: Motor assessment
MDS-UPDRS scale PART III
Other: Neurocognitive assessment
MoCA and MMSE scales
Other: 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)
Other: Taste tests
Recording of PEGs in response to a sucrose solution and a free fatty acid solution (prepared beforehand)
Experimental: Patients with Lewy body disease (LBD) progressing ≤ 3 years
Biological: Fasting blood test
metabolic assays determination of food intake hormones oxidative stress and neurodegeneration marker assays
Other: Subject interview
socio-demographic data, medical and family history, treatment taken
Other: Motor assessment
MDS-UPDRS scale PART III
Other: Neurocognitive assessment
MoCA and MMSE scales
Other: 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)
Other: Taste tests
Recording of PEGs in response to a sucrose solution and a free fatty acid solution (prepared beforehand)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average latency of taste-evoked potentials
Time Frame: After a 2-hour fasting period
After a 2-hour fasting period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCHNEIDER J'InvEST-I 2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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