N/A
N=44
Satiety and Alcohol Challenge
Alcohol Drinking
Bottom Line
View on ClinicalTrials.gov: NCT06576674 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Change in Alcohol Specific Satiety Score — -0.51; 4.85 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dietary Fiber + Green Tea Extract (Dietary_supplement); Alcohol (Other); Aspartame Placebo Supplement (Other)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Alcohol Specific Satiety Score |
-0.51; 4.85 | — |
| SECONDARY Change in Positive Affect Based on Subjective Effects of Alcohol Scale Score |
2.59; 2.84 | — |
| SECONDARY Change in Subjective Stimulation (Biphasic Alcohol Effects Scale) |
0.05; 0.05 | — |
| SECONDARY Change in Attention Bias to Alcohol Score |
-15.5; 6.63 | — |
| SECONDARY Change in Alcohol Demand Score |
-0.15; 0.00 | — |
| SECONDARY Change in Alcohol Urge Questionnaire Score |
3.66; 3.31 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
- Willingness to complete laboratory sessions involving blood draws and alcohol administration
- Ability to communicate and read in English
- Body mass index (BMI) of 21 - 30 kg/m^2
Exclusion Criteria
- Meets past-year criteria for severe Alcohol Use Disorder (>7 of 11 symptoms endorsed) or AUDIT score of 20+
- Meeting past-year criteria for a substance use disorder (with the exception of alcohol, tobacco or mild cannabis use disorder)
- Current engagement in alcohol treatments, or currently engaged in intentional efforts to quit alcohol use
- Current use of weight control medications
- Lifetime diagnosis of severe mental illness (including schizophrenia and bipolar disorder)
- History of suicide attempt, or psychiatric hospitalization in the last 6 months
- History of diabetes
- Medical conditions or medications for which alcohol is contraindicated
- Pregnant, nursing, or trying to become pregnant
- Plans to travel during the duration of study participation
Data sourced from ClinicalTrials.gov (NCT06576674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.