Effect of Alcohol Reduction and Probiotic Interventions on Cognition and Brain Glucose Metabolism in Normal Aging Adults Who Are High-Risk Alcohol Drinkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Total Cognition Composite score
研究概览
简要总结
The goal of this pilot study is to explore a combination of two interventions: (1) a behavioral alcohol-reduction intervention using motivational interviewing, and (2) a blinded probiotic microbiome or placebo intervention. The study examines whether these interventions improve cognitive and neurophysiological function, including brain metabolism, in older adults who are high-risk alcohol drinkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 84 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 65 and 84 years of age
- •English speaking
- •Able to provide valid informed consent, understand requirement and risk/benefits of the study and comply with study protocol
- •Heavy drinker defined as >14 alcoholic drinks/week for men and >7 drinks/week for women
- •Interested in reducing their alcohol consumption
排除标准
- •Fasting Glucose > 125 mg/dL
- •Current or previously diagnosed with Type 1 or 2 Diabetes
- •Requires the use of insulin and/or other glucose lowering agents
- •Unable to fast for 12 hours
- •Past serious alcohol withdrawal symptoms
- •MRI Contraindications (e.g., certain devices and implants, claustrophobic)
- •Diagnosed with a neurodegenerative disease (e.g., Alzheimer's Disease)
- •Diagnosed with a psychotic disorder
- •Current substance dependence diagnosis (except for mild or moderate alcohol)
- •Consumption of over 300 drinks in the past 30 days
- •Current probiotic use or recent probiotic use within the past 30 days
- •Current antibiotic use or recent antibiotic use within the past 30 days
- •In active cancer treatment and/or have advanced cancer
- •Taking daily steroids and/or immunosuppressants
- •Lifetime organ or bone marrow transplant; primary immunodeficiency (e.g., DiGeorge syndrome or Wiskott-Aldrich syndrome) or transplant recipient or prescribed immunosuppressant medications
- •PI's discretion
研究组 & 干预措施
Motivational Interviewing + Probiotic
Participants in this arm will be given a brief motivational interview to promote drinking reduction. During the 30-day intervention, participants will receive an active probiotic supplement 900 billion colony forming units (CFU), once daily.
干预措施: Visbiome (Dietary Supplement)
Motivational Interviewing + Probiotic
Participants in this arm will be given a brief motivational interview to promote drinking reduction. During the 30-day intervention, participants will receive an active probiotic supplement 900 billion colony forming units (CFU), once daily.
干预措施: Motivational Interviewing (Behavioral)
Motivational Interviewing + Placebo
Participants in this arm will be given a brief motivational interview to promote drinking reduction. During the 30-day intervention, participants will receive a placebo supplement once daily.
干预措施: Motivational Interviewing (Behavioral)
Motivational Interviewing + Placebo
Participants in this arm will be given a brief motivational interview to promote drinking reduction. During the 30-day intervention, participants will receive a placebo supplement once daily.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Total Cognition Composite score
时间窗: Baseline, 30 days
Cognitive performance will be assessed using the NIH Toolbox Cognition Battery v3 to measure the Total Cognition Composite score at two time-points and examined for change within subjects.
Change in Brain Metabolism
时间窗: Baseline, 30 days
Brain metabolism will be assessed using magnetic resonance spectroscopy (MRS) to quantify glucose uptake.
次要结局
未报告次要终点
研究者
Teddy Salan
Research Assistant Professor
University of Miami