Exploring how fullness affects alcohol consumption
Effect of a Dietary Supplement on Satiety and Acute Responses to Laboratory Alcohol Challenge
NA · University of North Carolina, Chapel Hill · NCT06576674
This study is testing if feeling full from a fiber and green tea supplement changes how much alcohol people drink and how they react to it.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 21 Years to 45 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill (other) |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06576674 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the influence of satiety on alcohol drinking behavior using a controlled laboratory setting. Participants will consume either a dietary supplement containing fiber and green tea or a placebo before undergoing an alcohol challenge. Their responses to alcohol will be assessed through standardized questionnaires and cognitive tasks over a two-hour period. The study aims to understand how feelings of fullness may alter the effects of alcohol consumption.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-45 who engage in at-risk drinking behaviors.
Not a fit: Patients with severe alcohol use disorder or those currently undergoing treatment for alcohol dependence may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how dietary interventions might help manage alcohol consumption and reduce drinking-related harms.
How similar studies have performed: While the specific approach of manipulating satiety in relation to alcohol consumption is novel, similar studies have explored dietary influences on drinking behavior with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina — Chapel Hill, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Jimikaye Courtney, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Michael Bremmer, MA
- Email: mbremmer@unc.edu
- Phone: 216-376-7846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alcohol Drinking