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
| NCT ID | NCT07415707 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Miami |
| Condition | Aging |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-02-26 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-02-26 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Teddy Salan, PhD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT07415707 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 84 Years, studying Aging. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07415707 currently recruiting?
Yes, NCT07415707 is actively recruiting participants. Contact the research team at txs785@med.miami.edu for enrollment information.
Where is the NCT07415707 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT07415707 clinical trial?
NCT07415707 is sponsored by University of Miami. The principal investigator is Teddy Salan, PhD at University of Miami. The trial plans to enroll 20 participants.