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| Name | Class |
|---|---|
| University of Tennessee | OTHER |
| University of Tennessee Medical Center | OTHER |
| East Tennessee State University | OTHER |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy controls | Experimental | The control arm follows the same dietary educational intervention as the neurodegenerative arm. In the first week (week 0), baseline data, stool and blood samples, and dietary data is collected. The dietary educational intervention begins after baseline and comprises weeks 1-7. During these weeks, participants learn about the MIND diet, keep dietary records, and complete weekly questionnaires. The dietary education intervention consists of a brief meeting with a study team member, weekly emails, instructional videos, handouts, and a MIND diet cookbook. Stool is collected at baseline, and weeks 4 and 7. Venipuncture is performed in week 0 and 7 (before and after the intervention). |
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| Participants with a neurodegenerative disease (amyotrophic lateral sclerosis or Parkinson's disease) | Experimental | People who have been diagnosed with either ALS or PD will enroll in an 8-week study. In the first week (week 0), baseline data, stool and blood samples, and dietary data will be collected. The dietary educational intervention begins after baseline and comprises weeks 1-7. During these weeks, participants learn about the MIND diet, keep dietary records, and complete weekly questionnaires. The dietary education intervention consists of a brief meeting with a study team member, weekly emails, instructional videos, handouts, and a MIND diet cookbook. Stool is collected at baseline, and weeks 4 and 7. Venipuncture is performed in week 0 and 7 (before and after the intervention). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The MIND diet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Blood collection will occur at baseline (day 1) and upon study completion, an average of 7 weeks. |
| Weight |
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Inclusion Criteria for Participants with ALS:
Meet the El Escorial Criteria for definite, probable, or possible ALS:
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:
Inclusion Criteria for Participants with PD:
Exclusion Criteria for Participants with PD:
Inclusion Criteria for Healthy Controls:
Exclusion Criteria for Healthy Controls:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Hope Morgan, PhD, MSN, FNP-BC, RN | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gary E Shealy Memorial ALS Clinic | Elizabethton | Tennessee | 37643 | United States | ||
| University Neurology |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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Weight, measured in pounds (lb) and converted to kilograms (kg). Weight prior to enrollment will be abstracted from the medical record. |
| 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. | baseline |
| ALS hand grip strength | pounds (lbs) | 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. | 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) | baseline (day 1) and upon study completion, an average of 7 weeks |
| blood pressure | mm/Hg | 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. | 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 | 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. | 1) the clinical visit prior to enrollment, an average of 3 months, 2) baseline, and 3) upon study completion, an average of 7 weeks |
| Knoxville |
| Tennessee |
| 37920 |
| United States |
| The Cole Center for Parkinson's & Movement Disorders | Knoxville | Tennessee | 37922 | United States |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |