Brief summary template The goal of this trial is to test the feasibility and efficacy of the Mediterranean-DASH Intervention for Neurodegenerative Delay (the MIND diet) in people living with amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD) and healthy controls. The main question\[s\] it aims to answer are: * How feasibile is our educational dietary intervention, which teaches participants with ALS, PD, and healthy controls to eat by the neuroprotective MIND dietary pattern? * How does the MIND dietary pattern affect the gut microbiome, metabolome, and lipidome in people with a neurodegenerative disease (ALS or PD) and healthy controls? * Does the MIND diet affect clinical measures of ALS and PD? * Does the MIND diet affect human biomarkers of systemic inflammation, metabolism, and neurodegeneration? Participants will: * Receive a MIND diet cookbook, a folder with educational handouts, and weekly emails with links to educational videos about the MIND diet. * Complete a food diary, a MIND diet tracker, and a weekly questionnaire about their experience of eating by the MIND diet. * Collect stool specimens at the beginning, middle, and end of the study. * Undergo venipuncture at the beginning and end of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
43
Participants meet briefly in person with a study team member to receive study materials (e.g., a MIND diet cookbook, a folder, olive oil, and stool collection kits) and an introduction to the MIND dietary pattern. Instruction includes recognizing the 10 healthy food categories (green leafy vegetables, other vegetables, berries, beans \& legumes, poultry, seafood, whole grains, nuts, wine, and olive oil as the primary oil) and the 5 food categories that are to be limited (sweets, butter/margarine, red meats, eggs, and cheese). Participants receive weekly emails with links to educational videos about the MIND diet, handouts about the MIND diet food categories, serving/portion sizes, and weekly questionnaires. Participants keep food diaries a minimum of three days per week, and complete a daily MIND diet tracker, which reinforces learning the MIND dietary pattern.
Gary E Shealy Memorial ALS Clinic
Elizabethton, Tennessee, United States
University Neurology
Knoxville, Tennessee, United States
The Cole Center for Parkinson's & Movement Disorders
Knoxville, Tennessee, United States
MIND Diet Score (MDS)
The MIND Diet Score (MDS) originally included 10 "brain-healthy" food categories, and 5 "unhealthy" food categories. Zero is equivalent to no adherence to the MIND diet and 15 is the highest possible adherence. The MDS is calculated for each week of the study. In this study, the maximum score will be 13, since we did not collect daily measures of olive oil and wine (2 out of 15 categories of healthy foods).
Time frame: From baseline to the end of 8 weeks
Gut microbiome
A metagenomic approach will be utilized to sequence the total DNA from participants' stool samples. Standard metagenomic pipelines will be used to identify the microbiome composition and determine their relative abundances (e.g., percentages, relative abundance). Associations between the MIND Diet Score (MDS) and gut microbiome will be tested.
Time frame: Stool is collected at three time points and analyzed by metagenomic sequencing: at baseline, 4 weeks after beginning the intervention, and 7 weeks after beginning the intervention
Metabolomics and lipidomics for plasma and stool specimens
Data will be analyzed by standard pipelines like MetaboAnalyst for relative abundances (peak area/intensity) of metabolites and lipids.
Time frame: Stool will be collected during baseline (days 1-7), during the 4th week of intervention (days 21-28), and during week 7 (days 42-49). Blood will be collected at baseline (day 1) and through study completion, an average of 7 weeks.
Biomarkers from plasma
Biomarkers of systemic inflammation, intestinal permeability, and metabolism will be quantified using ELISAs or multiplexing measured in units of concentration (pg/mL).
Time frame: Blood collection will occur at baseline (day 1) and upon study completion, an average of 7 weeks.
Weight
Weight, measured in pounds (lb) and converted to kilograms (kg). Weight prior to enrollment will be abstracted from the medical record.
Time frame: Prior to enrollment, an average of 3 months; baseline; and upon study completion, an average of 7 weeks.
Height
Height will be abstracted from the subject's medical record and recorded in inches, then converted to centimeters.
Time frame: baseline
ALS hand grip strength
pounds (lbs)
Time frame: baseline and upon completion of the study, an average of 7 weeks
Unified Parkinson's Disease Rating Scale (UPDRS) for PD
A 4-part, 0-199 point scale used to measure Parkinson's severity, where higher scores indicate greater impairment and a score of 0 indicated normal. UPDRS inventories mental state, daily activities, motor function, and treatment complications.
Time frame: baseline (day 1) and upon study completion, an average of 7 weeks.
ALS functional rating score-revised (ALSFRS-R)
total score ranges from 48 (normal function) to 0 (severe impairment)
Time frame: baseline (day 1) and upon study completion, an average of 7 weeks
blood pressure
mm/Hg
Time frame: baseline and upon study completion, an average of 7 weeks
Hoehn and Yahr (modified H&Y) score for PD
A clinician-rated scale assessed by the movement disorder specialist to assess the progression of PD from Stage 1.0 - Stage 5.0). Each stage is described as follows. Stage 1.0: Symptoms affect only one side of the body (unilateral). Stage 1.5: Unilateral and axial (midline/neck/trunk) involvement. Stage 2.0: Bilateral involvement (both sides) without balance impairment. Stage 2.5: Mild bilateral disease with recovery on the pull test (test of postural stability). Stage 3.0: Mild to moderate bilateral disease, some postural instability, but physically independent. Stage 4.0: Severe disability; however, still able to walk or stand unassisted. Stage 5.0: Confinement to a wheelchair or bed unless assisted.
Time frame: baseline and upon study completion, an average of 7 weeks
body mass index (BMI)
weight and height will be combined to report BMI in kg/m\^2
Time frame: baseline and upon study completion, an average of 7 weeks
Rate of weight change for ALS participants
Rate and direction of weight change per unit of time (e.g., change in weight (lbs)/weeks) will be collected from the ALS patients' medical records prior to the intervention and during the intervention to compare the rate of change before the study and during the intervention.
Time frame: 1) the clinical visit prior to enrollment, an average of 3 months, 2) baseline, and 3) upon study completion, an average of 7 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.