Reducing alcohol and trying a probiotic to improve thinking and brain glucose use in older high-risk drinkers
Effect of Alcohol Reduction and Probiotic Interventions on Cognition and Brain Glucose Metabolism in Normal Aging Adults Who Are High-Risk Alcohol Drinkers
This study will test whether reducing alcohol with motivational interviewing plus taking a blinded probiotic or placebo can improve thinking and brain glucose metabolism in people ages 65–84 who drink heavily.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 65 Years to 84 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07415707 on ClinicalTrials.gov |
What this trial studies
This pilot interventional study enrolls older adults who are high-risk alcohol drinkers and combines a behavioral alcohol-reduction program using motivational interviewing with a randomized, blinded probiotic (Visbiome) or placebo. Participants will be monitored for changes in cognitive performance and neurophysiological measures, including brain glucose metabolism. The probiotic intervention is double-blinded while the behavioral component is delivered to all participants who want to reduce drinking. Outcomes will compare cognitive and brain metabolism measures before and after the combined interventions.
Who should consider this trial
Good fit: Ideal candidates are English-speaking men and women aged 65–84 who are heavy drinkers (>14 drinks/week for men, >7 drinks/week for women) and are willing to try reducing their alcohol use and attend on-site visits.
Not a fit: Patients with BMI ≥35, diabetes or fasting glucose >125 mg/dL, current insulin or glucose-lowering therapy, prior serious alcohol withdrawal, diagnosed neurodegenerative or psychotic disorders, current substance dependence (other than mild/moderate alcohol), recent probiotic use, MRI contraindications, or excessive recent drinking are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the approach could lead to improved cognitive function and healthier brain glucose metabolism in older adults who reduce alcohol and alter their gut microbiome.
How similar studies have performed: Prior alcohol-reduction programs have improved some cognitive outcomes and probiotics show early, mixed evidence for brain effects, but combining motivational alcohol reduction with a blinded probiotic is largely novel and unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Teddy Salan, PhD — University of Miami
- Study coordinator: Teddy Salan, PhD
- Email: txs785@med.miami.edu
- Phone: 305-243-9228
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.