AgingNCT07415707
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
A study testing Visbiome and Motivational Interviewing in people with Aging and Alcohol Drinking, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 84 years
- Conditions the study is for
- Aging, Alcohol Drinking
- What is being tested?
- Visbiome and Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 84 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Teddy Salan, PhD, 305-243-9228, txs785@med.miami.edu
Teddy Salan, PhD
About this study
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
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.
- Conditions
- Aging, Alcohol Drinking
- Being tested
- Visbiome, Motivational Interviewing, Placebo
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisbiomeDietary supplement
Participants will receive 900 billion Colony Forming Units (CFU) once daily for 30 days
Motivational InterviewingBehavioural
Participants will receive one counseling session at baseline via video call, lasting up to 30 minutes
PlaceboOther
Participants will receive a standard placebo designed to resemble the probiotic once daily for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing + Probiotic | Experimental | Participants in this arm will be given a brief motivational interview to promote drinking reduction. During the 30-day intervention, participants will receive an active probiotic supplement 900 billion colony forming units (CFU), once daily. Receives: Dietary Supplement: Visbiome; Behavioral: Motivational Interviewing |
| Motivational Interviewing + Placebo | Placebo comparator | Participants in this arm will be given a brief motivational interview to promote drinking reduction. During the 30-day intervention, participants will receive a placebo supplement once daily. Receives: Behavioral: Motivational Interviewing; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Cognition Composite score
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.
Measured: Baseline, 30 days
Change in Brain Metabolism
Brain metabolism will be assessed using magnetic resonance spectroscopy (MRS) to quantify glucose uptake.
Measured: Baseline, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start26 Feb 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Exegi Pharma
- Responsible party
- Principal investigator, Teddy Salan, University of Miami
- Investigators
- Teddy Salan, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415707
- Sponsor's protocol ID
- 20250474
- Status last verified
- Mar 2026
- First submitted
- 22 Jan 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07415707
- Acronym / sponsor ID
- 20250474
- Conditions
- Aging, Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Exegi Pharma
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing + Probiotic | Experimental | Dietary Supplement: Visbiome, Behavioral: Motivational InterviewingParticipants in this arm will be given a brief motivational interview to promote drinking reduction. During the 30-day intervention, participants will receive an active probiotic supplement 900 billion colony forming units (CFU), once daily. |
| Motivational Interviewing + Placebo | Placebo comparator | Behavioral: Motivational Interviewing, Other: PlaceboParticipants in this arm will be given a brief motivational interview to promote drinking reduction. During the 30-day intervention, participants will receive a placebo supplement once daily. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VisbiomeParticipants will receive 900 billion Colony Forming Units (CFU) once daily for 30 days | Dietary supplement | Motivational Interviewing + Probiotic |
| Motivational InterviewingParticipants will receive one counseling session at baseline via video call, lasting up to 30 minutes | Behavioural | Motivational Interviewing + Placebo, Motivational Interviewing + Probiotic |
| PlaceboParticipants will receive a standard placebo designed to resemble the probiotic once daily for 30 days | Other | Motivational Interviewing + Placebo |
Primary outcome
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.
Change in Brain Metabolism
Time frame: Baseline, 30 days
Brain metabolism will be assessed using magnetic resonance spectroscopy (MRS) to quantify glucose uptake.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Teddy Salan, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visbiome and Motivational Interviewing in people with Aging and Alcohol Drinking, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teddy Salan, PhD (305-243-9228, txs785@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Cognition Composite score (time frame: Baseline, 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.