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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.