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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Visbiome, Motivational Interviewing, Placebo.
- Who it may be relevant to
- Registry conditions: Aging, Alcohol Drinking. Basic parameters: 65 years — 84 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Alcohol Reduction and Probiotic Interventions on Cognition and Brain Glucose Metabolism in Normal Aging Adults Who Are High-Risk Alcohol Drinkers
Overview
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 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 - Other Placebo
Participants will receive a standard placebo designed to resemble the probiotic once daily for 30 days
Primary outcome measures
- Change in Total Cognition Composite score [Time frame: Baseline, 30 days]
- Change in Brain Metabolism [Time frame: Baseline, 30 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT07415707 · 20250474