RecruitingNot ApplicableNCT07415707

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

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


Sponsor

University of Miami

Enrollment

20 participants

Start Date

Feb 26, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 65 YearsMax Age: 84 Years

Inclusion Criteria5

  • 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 Criteria17

  • 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

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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


Locations(1)

University of Miami

Miami, Florida, United States

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NCT07415707


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