NCT07625605已完成不适用
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)
The University of Tennessee, Knoxville3 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2023年11月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 3
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
研究者
Katherine Morgan
Principal Investigator
The University of Tennessee, Knoxville
研究点 (3)
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