Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The University of Tennessee, Knoxville
With
University of Tennessee
University of Tennessee Medical Center
East Tennessee State University
Age
30–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Meet the El Escorial Criteria for definite, probable, or possible ALS:
* Definite ALS is defined as presence of upper motor neuron (UMN) and lower motor neuron (LMN) signs in the bulbar region and at 2 of the other spinal regions
* Probable ALS is defined as presence of UMN and LMN in at least 2 regions with UMN signs rostral to LMN signs; probable ALS supported by laboratory results is defined as presence of UMN in 1 region with electromyographic evidence of LMN involvement in another region
* Possible ALS is defined as presence of UMN and LMN in 1 region or UMN in 2 or 3 regions (monomelic ALS, progressive bulbar palsy, and primary lateral sclerosis)
Voluntarily participate and able to consent
Have internet access
Willing to communicate by telephone or teleconferencing, and email
Minimum age of 30 years old
Able to masticate (chew) and swallow at the time of the study
Willing to return to the clinic eight weeks after enrolling for a regularly scheduled visit and post intervention data collection, or if they are not patients of the clinical sites, then they are willing to come to the clinic twice for study activities (once at enrollment and once upon exiting).
Patient (and their caregiver, if needed) must be willing and able (in the Investigator's opinion) to comply with all study requirements
Meet clinical criteria for PD per the MDS clinical criteria (Postuma et al, Movement Disorders,
2015\) as determined by the treating Movement Disorder specialist
Hoehn Yar \< 2.5, as determined by the treating Movement Disorder Specialist.
Be 50 to 80 years of age upon enrollment.
Levodopa daily equivalents of no more than 500 a day
Subjects are within five years of the onset of symptoms at time of study enrollment.
Participants agree not to change PD medications during the 7-week dietary intervention.
Voluntarily participate and able to consent
Able to masticate (chew) and swallow at the time of the study
Have internet access
Willing to communicate by telephone or teleconferencing, and email
Voluntarily participate and able to consent
Able to speak, read, and write English
Internet access,
Willing to communicate by telephone or teleconferencing, and email
Minimum age of 30 years
Able to masticate (chew) and swallow at the time of the study
Willing to visit the clinic two times to complete study activities
Patient (and their caregiver, if needed) must be willing and able (in the Investigator's opinion) to
comply with all study requirements
You may not be if
Patients that require a special diet (celiac/gluten free, vegetarian, or vegan)
Antibiotic use in past 6 months
History of bowel diseases or cancer (e.g., irritable bowel syndrome, celiac sprue, Crohn's
Younger than age 30
Unable to provide consent
Feeding by tube feed or primarily liquid diets
Unable to masticate or swallow.
May not be taking medications concerning for a drug induced parkinsonism two years prior to
study entry such as antipsychotics, metoclopramide (Reglan), prochlorperazine (Compazine),
promethazine (Phenergan) or amiodarone
The movement disorder specialist must find no red flags for concern for atypical or Parkinson's Plus per the MDS diagnostic criteria (Postuma et al)
Patients that require a special diet (celiac/gluten free, vegetarian, or vegan)
Antibiotic use in past 6 months
History of bowel diseases or cancer (e.g., irritable bowel syndrome, celiac sprue, Crohn's Disease, colorectal cancer)
Unable to provide consent or struggling with major cognitive concerns as determined by the
treating Movement Disorder specialist
Feeding by tube feed or primarily liquid diets
Unable to masticate or swallow.
Healthy people who require a special diet (celiac/gluten free, vegetarian, or vegan)
Antibiotic use in past 6 months
History of bowel diseases or cancer (e.g., irritable bowel syndrome, celiac sprue, Crohn's Disease, colorectal cancer)
Younger than age 30
Unable to consent
Feeding by tube feed or primarily liquid diets
Diagnosis with any neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis, peripheral neuropathies).
