Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07415707

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

65 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Teddy Salan, PhD

CONTACT

[email protected]

305-243-9228

Teddy Salan, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visbiome

Dietary Supplement

Participants will receive 900 billion Colony Forming Units (CFU) once daily for 30 days

Motivational Interviewing

Behavioral

Participants will receive one counseling session at baseline via video call, lasting up to 30 minutes

Placebo

Other

Participants will receive a standard placebo designed to resemble the probiotic once daily for 30 days

Primary outcomes

  1. Change in Total Cognition Composite score

    Time frame: 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.

  2. Change in Brain Metabolism

    Time frame: Baseline, 30 days

    Brain metabolism will be assessed using magnetic resonance spectroscopy (MRS) to quantify glucose uptake.

Study contacts

Contact information is provided by the study sponsor or research team.

Teddy Salan, PhD

CONTACT

[email protected]

305-243-9228

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Exegi Pharma

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.