The Meals Study for Amyotrophic Lateral Sclerosis and Parkinson's Disease (NCT07625605) | Clinical Trial Compass
CompletedNot Applicable
The Meals Study for Amyotrophic Lateral Sclerosis and Parkinson's Disease
United States43 participantsStarted 2023-11-20
Plain-language 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.
Who can participate
Age range
30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, vegeta…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is already completed and was measuring things like diet scores, gut bacteria, and blood and stool metabolites in people with ALS or Parkinson's — has the data been published yet, and if so, what did it find about the role of diet and gut health in these conditions?
2Since this was a diet-focused observational study rather than a treatment trial, does what researchers learned here about the MIND diet and gut microbiome actually change any recommendations you'd make for my care right now?
3The study collected stool and blood samples to look at metabolomics and lipidomics — can you help me understand what those measurements tell us about how diet might be affecting disease progression in ALS or Parkinson's, and whether that's relevant to my situation?
4Are there any follow-up studies or active clinical trials building on what this MIND diet study found that might be worth considering, given that this one is already completed?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MIND Diet Score (MDS)
Timeframe: From baseline to the end of 8 weeks
2
Gut microbiome
Timeframe: 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
3
Metabolomics and lipidomics for plasma and stool specimens
Timeframe: 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.