Aging, Alcohol Drinking
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVisbiome
Participants will receive 900 billion Colony Forming Units (CFU) once daily for 30 days
BEHAVIORALMotivational Interviewing
Participants will receive one counseling session at baseline via video call, lasting up to 30 minutes
OTHERPlacebo
Participants will receive a standard placebo designed to resemble the probiotic once daily for 30 days
Sponsors
University of Miami
Exegi Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 84 Years
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
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Cognition Composite score | 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 | Baseline, 30 days | Brain metabolism will be assessed using magnetic resonance spectroscopy (MRS) to quantify glucose uptake. |
Countries
United States
Contacts
CONTACTTeddy Salan, PhD
PRINCIPAL_INVESTIGATORTeddy Salan, PhD
University of Miami
Outcome results
None listed