Amyotrophic Lateral Sclerosis (ALS), Parkinson's Disease (PD)
Conditions
Keywords
Mediterranean-DASH Intervention to Delay Neurodegeneration, MIND diet, microbiome, metabolome, dietary educational intervention
Brief summary
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.
Interventions
BEHAVIORALThe MIND diet
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.
Sponsors
The University of Tennessee, Knoxville
University of Tennessee
University of Tennessee Medical Center
East Tennessee State University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for Participants with ALS: * 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
Exclusion criteria
for Participants with ALS: * 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. Inclusion Criteria for Participants with PD: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MIND Diet Score (MDS) | From baseline to the end of 8 weeks | 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). |
| Gut microbiome | 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 | 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. |
| Metabolomics and lipidomics for plasma and stool specimens | 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. | Data will be analyzed by standard pipelines like MetaboAnalyst for relative abundances (peak area/intensity) of metabolites and lipids. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers from plasma | Blood collection will occur at baseline (day 1) and upon study completion, an average of 7 weeks. | Biomarkers of systemic inflammation, intestinal permeability, and metabolism will be quantified using ELISAs or multiplexing measured in units of concentration (pg/mL). |
| Weight | Prior to enrollment, an average of 3 months; baseline; and upon study completion, an average of 7 weeks. | Weight, measured in pounds (lb) and converted to kilograms (kg). Weight prior to enrollment will be abstracted from the medical record. |
| Height | baseline | Height will be abstracted from the subject's medical record and recorded in inches, then converted to centimeters. |
| ALS hand grip strength | baseline and upon completion of the study, an average of 7 weeks | pounds (lbs) |
| Unified Parkinson's Disease Rating Scale (UPDRS) for PD | baseline (day 1) and upon study completion, an average of 7 weeks. | 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. |
| ALS functional rating score-revised (ALSFRS-R) | baseline (day 1) and upon study completion, an average of 7 weeks | total score ranges from 48 (normal function) to 0 (severe impairment) |
| blood pressure | baseline and upon study completion, an average of 7 weeks | mm/Hg |
| Hoehn and Yahr (modified H&Y) score for PD | baseline and upon study completion, an average of 7 weeks | 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. |
| body mass index (BMI) | baseline and upon study completion, an average of 7 weeks | weight and height will be combined to report BMI in kg/m\^2 |
| Rate of weight change for ALS participants | 1) the clinical visit prior to enrollment, an average of 3 months, 2) baseline, and 3) upon study completion, an average of 7 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKatherine Hope Morgan, PhD, MSN, FNP-BC, RN
University of Tennessee
Outcome results
None listed