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Dietary Fiber + Green Tea Extract for Alcohol Consumption (SatTAC Trial)

N/A
Waitlist Available
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
* Meeting NIAAA criteria for current at-risk drinking (i.e., \>7/14 drinks in one week for women/men, with at least one episodes of 4+/5+ drinks in the past 30 days)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 60 minutes
Awards & highlights

Summary

The goal of this pilot study is to identify the role of satiety on responses to alcohol drinking using human subject laboratory methods. Satiety will be manipulated over two sessions using a dietary supplement (fiber+green tea) or a calorically matched placebo. Responses to an acute alcohol challenge are measured.

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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 60 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 60 minutes for reporting.

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 more

Trial 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.

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Who is running the clinical trial?

Research Society on Alcohol (RSA)UNKNOWN
North Carolina Translational and Clinical Sciences InstituteOTHER
58 Previous Clinical Trials
4,363 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,527 Previous Clinical Trials
4,197,237 Total Patients Enrolled
~37 spots leftby Jul 2025
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