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Dietary Fiber + Green Tea Extract for Alcohol Consumption (SatTAC Trial)
N/A
Recruiting
Led By Jimikaye Courtney, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 21-45
Be between 18 and 65 years old
Must not have
Medical conditions or medications for which alcohol is contraindicated
Current use of weight control medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 60 minutes
Summary
This trial aims to understand how feeling full affects how people respond to drinking alcohol. Participants will be given a dietary supplement or a placebo to make them feel full, and then their reactions to alcohol will be
Who is the study for?
This trial is for individuals who consume alcohol. Specific eligibility criteria are not provided, but typically participants would need to be healthy adults willing to have their satiety manipulated and alcohol response measured over two sessions.
What is being tested?
The study tests how feeling full (satiety) affects reactions to drinking alcohol. Participants will take a dietary supplement with fiber and green tea or a placebo that has no active ingredients before an alcohol challenge in two separate sessions.
What are the potential side effects?
Possible side effects may include digestive discomfort from the dietary fiber, caffeine-related side effects from the green tea extract such as jitteriness or insomnia, and typical effects of alcohol consumption like drowsiness or impaired coordination.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 45 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot consume alcohol due to my medical condition or medications.
Select...
I am currently taking medication to help control my weight.
Select...
I have not attempted suicide or been hospitalized for psychiatric reasons in the last 6 months.
Select...
I have a history of diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 60 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in alcohol specific satiety score
Secondary study objectives
Attention bias to alcohol
Change in AUQ score
Change in BAES Score
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: placebo, then dietary supplementExperimental Treatment3 Interventions
Participants receive a placebo supplement at the first study session (Aspartame sweetener mixed with water + aspartame capsule), then the next session they receive the dietary supplement (10g Fibersol®-2 mixed with water and aspartame sweetener + 725mg decaffeinated green tea extract capsule). Participants will also receive a drink containing alcohol (vodka + cranberry mixer) on both sessions.
Group II: dietary supplement, then placeboExperimental Treatment3 Interventions
Participants receive a dietary supplement at the first study session (10g Fibersol®-2 mixed with water and aspartame sweetener + 725mg decaffeinated green tea extract capsule), and then the next study session they receive the placebo supplement (Aspartame sweetener mixed with water + aspartame capsule). Participants will also receive a drink containing alcohol (vodka + cranberry mixer) on both sessions.
Find a Location
Who is running the clinical trial?
Research Society on Alcohol (RSA)UNKNOWN
North Carolina Translational and Clinical Sciences InstituteOTHER
59 Previous Clinical Trials
4,403 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,569 Previous Clinical Trials
4,319,652 Total Patients Enrolled
Jimikaye Courtney, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill