The GLUCID Study: Effect of Alcohol Reduction and Probiotic Interventions on Cognition and Brain Glucose Metabolism in Normal Aging Adults Who Are High-Risk Alcohol Drinkers

Purpose

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.

Conditions

  • Aging
  • Alcohol Drinking

Eligibility

Eligible Ages
Between 65 Years and 84 Years
Eligible 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

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Dietary Supplement: Visbiome
    Participants will receive 900 billion Colony Forming Units (CFU) once daily for 30 days
  • Behavioral: Motivational Interviewing
    Participants will receive one counseling session at baseline via video call, lasting up to 30 minutes
Placebo Comparator
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.
  • Behavioral: Motivational Interviewing
    Participants will receive one counseling session at baseline via video call, lasting up to 30 minutes
  • Other: Placebo
    Participants will receive a standard placebo designed to resemble the probiotic once daily for 30 days

Recruiting Locations

University of Miami
Miami, Florida 33136
Contact:
Teddy Salan, PhD
305-243-9228
txs785@med.miami.edu

More Details

Status
Recruiting
Sponsor
University of Miami

Study Contact

Teddy Salan, PhD
305-243-9228
txs785@med.miami.edu