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.
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
BMI ≥ 35
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
Parallel
Visbiome
Dietary supplementParticipants will receive 900 billion Colony Forming Units (CFU) once daily for 30 days
Motivational Interviewing
BehavioralParticipants will receive one counseling session at baseline via video call, lasting up to 30 minutes
Placebo
Other interventionParticipants will receive a standard placebo designed to resemble the probiotic once daily for 30 days
Change in Total Cognition Composite score
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
Brain metabolism will be assessed using magnetic resonance spectroscopy (MRS) to quantify glucose uptake.
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University of Miami
Lead sponsor
Exegi Pharma
Collaborator
