Effect of Alcohol Reduction and Probiotic Interventions on Cognition and Brain Glucose Metabolism in Normal Aging Adults Who Are High-Risk Alcohol Drinkers
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Miami
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Total Cognition Composite score
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 65 Years to 84 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Change in Total Cognition Composite score
Time Frame: 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
Time Frame: Baseline, 30 days
Brain metabolism will be assessed using magnetic resonance spectroscopy (MRS) to quantify glucose uptake.
Secondary Outcomes
No secondary outcomes reported
Investigators
Teddy Salan
Research Assistant Professor
University of Miami