About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Visbiome
- Motivational Interviewing
- Placebo
Treatment groups
Sponsors and collaborators
University of Miami
Lead sponsor
Exegi Pharma
Collaborator