[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07415707":3,"trial-entities:NCT07415707":109,"trial-summary:NCT07415707":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":46,"secondary_outcomes":54,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":15,"eligibility_criteria":58,"std_ages":84,"locations":86,"central_contacts":103,"overall_officials":105,"references":107,"see_also_links":108},"NCT07415707","20250474","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","Effect of Alcohol Reduction and Probiotic Interventions on Cognition and Brain Glucose Metabolism in Normal Aging Adults Who Are High-Risk Alcohol Drinkers","RECRUITING","2027-04-30","2026-03","2026-03-04","2026-02-26","University of Miami","OTHER",false,"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.",null,[19,20],"Aging","Alcohol Drinking",[],"INTERVENTIONAL","BASIC_SCIENCE",[25],"NA",{"count":27,"type":28},20,"ESTIMATED",[30,36,42],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DIETARY_SUPPLEMENT","Visbiome","Participants will receive 900 billion Colony Forming Units (CFU) once daily for 30 days",[35],"Motivational Interviewing + Probiotic",{"type":37,"name":38,"description":39,"armGroupLabels":40},"BEHAVIORAL","Motivational Interviewing","Participants will receive one counseling session at baseline via video call, lasting up to 30 minutes",[41,35],"Motivational Interviewing + Placebo",{"type":14,"name":43,"description":44,"armGroupLabels":45},"Placebo","Participants will receive a standard placebo designed to resemble the probiotic once daily for 30 days",[41],[47,51],{"measure":48,"description":49,"timeFrame":50},"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.","Baseline, 30 days",{"measure":52,"description":53,"timeFrame":50},"Change in Brain Metabolism","Brain metabolism will be assessed using magnetic resonance spectroscopy (MRS) to quantify glucose uptake.",[],"ALL","65 Years","84 Years",{"inclusion":59,"exclusion":65,"raw_text":83},[60,61,62,63,64],"Between 65 and 84 years of age","English speaking","Able to provide valid informed consent, understand requirement and risk\u002Fbenefits of the study and comply with study protocol","Heavy drinker defined as \\>14 alcoholic drinks\u002Fweek for men and \\>7 drinks\u002Fweek for women","Interested in reducing their alcohol consumption",[66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82],"BMI ≥ 35","Fasting Glucose \\> 125 mg\u002FdL","Current or previously diagnosed with Type 1 or 2 Diabetes","Requires the use of insulin and\u002For 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\u002For have advanced cancer","Taking daily steroids and\u002For 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","Inclusion Criteria:\n\n* Between 65 and 84 years of age\n* English speaking\n* Able to provide valid informed consent, understand requirement and risk\u002Fbenefits of the study and comply with study protocol\n* Heavy drinker defined as \\>14 alcoholic drinks\u002Fweek for men and \\>7 drinks\u002Fweek for women\n* Interested in reducing their alcohol consumption\n\nExclusion Criteria:\n\n* BMI ≥ 35\n* Fasting Glucose \\> 125 mg\u002FdL\n* Current or previously diagnosed with Type 1 or 2 Diabetes\n* Requires the use of insulin and\u002For other glucose lowering agents\n* Unable to fast for 12 hours\n* Past serious alcohol withdrawal symptoms\n* MRI Contraindications (e.g., certain devices and implants, claustrophobic)\n* Diagnosed with a neurodegenerative disease (e.g., Alzheimer's Disease)\n* Diagnosed with a psychotic disorder\n* Current substance dependence diagnosis (except for mild or moderate alcohol)\n* Consumption of over 300 drinks in the past 30 days\n* Current probiotic use or recent probiotic use within the past 30 days\n* Current antibiotic use or recent antibiotic use within the past 30 days\n* In active cancer treatment and\u002For have advanced cancer\n* Taking daily steroids and\u002For immunosuppressants\n* Lifetime organ or bone marrow transplant; primary immunodeficiency (e.g., DiGeorge syndrome or Wiskott-Aldrich syndrome) or transplant recipient or prescribed immunosuppressant medications\n* PI's discretion",[85],"OLDER_ADULT",[87],{"facility":13,"status":8,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":100},"Miami","Florida","33136","United States",[93,98],{"name":94,"role":95,"phone":96,"email":97},"Teddy Salan, PhD","CONTACT","305-243-9228","txs785@med.miami.edu",{"name":94,"role":99},"PRINCIPAL_INVESTIGATOR",{"lat":101,"lon":102},25.77427,-80.19366,[104],{"name":94,"role":95,"phone":96,"email":97},[106],{"name":94,"affiliation":13,"role":99},[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[19,111],"Alcohol Consumption",[],{"nct_id":4,"found":114,"summary":115,"prompt_version":125},true,{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is an interventional study exploring two approaches: a behavioral intervention (motivational interviewing) and a blinded probiotic or placebo. It plans to enroll 20 participants.","completed","GLUCID Study: Alcohol Reduction and Probiotics for Cognition in Older Adults","This study, called GLUCID, is looking at how two interventions might affect thinking skills (cognition) and brain sugar use (metabolism) in older adults (ages 65-84) who drink a lot of alcohol. You would receive either a probiotic called Visbiome or a placebo (an inactive substance that looks like the probiotic) for 30 days. You would also have one counseling session to help reduce alcohol use. Researchers want to see if these interventions improve your thinking abilities and how your brain uses energy. The study aims to enroll 20 participants, but its current status is unclear.","Your cognition and brain metabolism will be measured at the beginning of the study and again after 30 days.",95,"You would receive a daily dietary supplement (Visbiome or placebo) for 30 days. You would also have one video call counseling session lasting up to 30 minutes.","Not stated in the trial record.",[32,43],"v2"]