The Meals Study for Amyotrophic Lateral Sclerosis and Parkinson's Disease (Meals)
2026년 5월 28일 업데이트: Katherine Morgan, The University of Tennessee, Knoxville
Assessing the Feasibility of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Dietary Pattern for Amyotrophic Lateral Sclerosis and Parkinson's Disease Treatment (Meals Study)
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.
연구 개요
연구 유형
중재적
등록 (실제)
43
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Tennessee
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Elizabethton, Tennessee, 미국, 37643
- Gary E Shealy Memorial ALS Clinic
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Knoxville, Tennessee, 미국, 37920
- University Neurology
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Knoxville, Tennessee, 미국, 37922
- The Cole Center for Parkinson's & Movement Disorders
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
Exclusion Criteria for Participants with PD:
- 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.
Inclusion Criteria for Healthy Controls:
- 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
Exclusion Criteria for Healthy Controls:
- 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).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Healthy controls
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 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.
다른 이름들:
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실험적: Participants with a neurodegenerative disease (amyotrophic lateral sclerosis or Parkinson's disease)
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).
|
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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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MIND Diet Score (MDS)
기간: From baseline to the end of 8 weeks
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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).
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From baseline to the end of 8 weeks
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Gut microbiome
기간: 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
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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.
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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
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Metabolomics and lipidomics for plasma and stool specimens
기간: 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.
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Data will be analyzed by standard pipelines like MetaboAnalyst for relative abundances (peak area/intensity) of metabolites and lipids.
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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.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Biomarkers from plasma
기간: Blood collection will occur at baseline (day 1) and upon study completion, an average of 7 weeks.
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Biomarkers of systemic inflammation, intestinal permeability, and metabolism will be quantified using ELISAs or multiplexing measured in units of concentration (pg/mL).
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Blood collection will occur at baseline (day 1) and upon study completion, an average of 7 weeks.
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Weight
기간: Prior to enrollment, an average of 3 months; baseline; and upon study completion, an average of 7 weeks.
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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.
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Prior to enrollment, an average of 3 months; baseline; and upon study completion, an average of 7 weeks.
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Height
기간: baseline
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Height will be abstracted from the subject's medical record and recorded in inches, then converted to centimeters.
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baseline
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ALS hand grip strength
기간: baseline and upon completion of the study, an average of 7 weeks
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pounds (lbs)
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baseline and upon completion of the study, an average of 7 weeks
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Unified Parkinson's Disease Rating Scale (UPDRS) for PD
기간: baseline (day 1) and upon study completion, an average of 7 weeks.
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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.
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baseline (day 1) and upon study completion, an average of 7 weeks.
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ALS functional rating score-revised (ALSFRS-R)
기간: baseline (day 1) and upon study completion, an average of 7 weeks
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total score ranges from 48 (normal function) to 0 (severe impairment)
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baseline (day 1) and upon study completion, an average of 7 weeks
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blood pressure
기간: baseline and upon study completion, an average of 7 weeks
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mm/Hg
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baseline and upon study completion, an average of 7 weeks
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Hoehn and Yahr (modified H&Y) score for PD
기간: baseline and upon study completion, an average of 7 weeks
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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
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body mass index (BMI)
기간: baseline and upon study completion, an average of 7 weeks
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weight and height will be combined to report BMI in kg/m^2
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baseline and upon study completion, an average of 7 weeks
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Rate of weight change for ALS participants
기간: 1) the clinical visit prior to enrollment, an average of 3 months, 2) baseline, and 3) upon study completion, an average of 7 weeks
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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.
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1) the clinical visit prior to enrollment, an average of 3 months, 2) baseline, and 3) upon study completion, an average of 7 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Katherine Hope Morgan, PhD, MSN, FNP-BC, RN, University of Tennessee
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2023년 11월 20일
기본 완료 (실제)
2025년 5월 21일
연구 완료 (실제)
2025년 5월 21일
연구 등록 날짜
최초 제출
2025년 11월 4일
QC 기준을 충족하는 최초 제출
2026년 5월 28일
처음 게시됨 (실제)
2026년 6월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 28일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 5081
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .