Satiety and Alcohol Challenge

Participants will receive a beverage containing either a dietary supplement (10g Fibersol®-2 mixed with water and aspartame sweetener for taste + 725mg decaffeinated green tea extract capsule) or a calorically matched placebo supplement (Aspartame sweetener mixed with water + aspartame capsule) counterbalanced at two separate visits. Forty-five minutes after the dietary supplement, a priming drink (calculated to achieve 0.03g/dL Blood Alcohol Concentration; BAC) is administered. Response to alcohol is measured using standardized questionnaires and a cognitive task. Then over a 2-hour period, additional mini-drinks are administered. Responses to standardized questionnaires are collected after each drink.

• Dietary Fiber + Green Tea Extract (Dietary supplement), also known as Fibersol®-2, decaffeinated green tea extract: 10g fiber + 750mg green tea supplement will be administered at experimental arm
• Alcohol (Other), also known as ethanol (ETOH): alcohol administered up to a target BAC 0.06g/dL during lab sessions
• Aspartame Placebo Supplement (Other), also known as Equal: Aspartame sweetener mixed with water + aspartame capsule

Primary outcomes

• Change in Alcohol Specific Satiety Score [baseline to 60 minutes]: The Alcohol-specific Satiety Questionnaire is a 16-item instrument designed to measure satiety to alcohol's effects. Ratings are made from Not at all; 0 to Extremely; 10, yielding total scores from 0 to 160 with higher values representing greater alcohol-specific satiety.

Secondary outcomes

• Change in Positive Affect Based on Subjective Effects of Alcohol Scale Score [baseline to 60 minutes]: The Subjective Effects of Alcohol Scale (SEAS) (0-70, 10 point scale) is a 14 item instrument designed to measure the magnitude of alcohol's subjective effects. Ratings are made from Not at all; 0 to Extremely; 10, yielding total scores from 0 to 70 with higher values indicating a greater subjective response to alcohol.
• Change in Subjective Stimulation (Biphasic Alcohol Effects Scale) [baseline to 60 minutes]: The Biphasic Alcohol Effect Scale (BAES) is a 14-item instrument designed to measure the stimulant and sedative subjective effects of alcohol. Ratings are made from Not at all; 0 to Extremely; 10, yielding total scores from 0 to 70 with higher values indicating a greater subjective response to alcohol.
• Change in Attention Bias to Alcohol Score [30 minutes after alcohol administration]: The Visual Dot-Probe Paradigm is used to measure attention bias to alcohol. Participants are asked to detect a target stimulus that is embedded in a matrix of distracting stimuli (e.g., a target stimulus, an alcohol related image, might be embedded in a matrix of neutral images). Attention biases are inferred from faster response times to detect a alcohol related stimulus in a matrix of neutral stimuli relative to response time to detect neutral stimuli in neutral matrices. Thus, positive times reflect attention bias toward alcohol, whereas negative times reflect attention bias away from alcohol.
• Change in Alcohol Demand Score [baseline to 60 minutes]: The Alcohol Purchase Task is a 20-question self-report measure which asks participants about the number of drinks they would purchase and consume based at different monetary costs. Intensity scores reflect the number of drinks that would be purchased when cost is zero.
• Change in Alcohol Urge Questionnaire Score [baseline to 60 minutes]: The Alcohol Urge Questionnaire (AUQ) is an 8 item instrument designed to measure the magnitude of alcohol's subjective effects. Ratings are made from Strongly agree; 1 to Agree; 7, yielding average scores from 1 to 7 with higher values indicating a greater alcohol craving.

Sex: All, ages: 21 Years to 45 Years, accepts healthy volunteers

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

Participant flow

Outcome results

• Change in Alcohol Specific Satiety Score (Primary), Mean, score on a scale: Dietary Supplement -0.51 +/- 5.25; Placebo 4.85 +/- 5.45
• Change in Positive Affect Based on Subjective Effects of Alcohol Scale Score (Secondary), Mean, score on a scale: Dietary Supplement 2.59 +/- 0.98; Placebo 2.84 +/- 0.94
• Change in Subjective Stimulation (Biphasic Alcohol Effects Scale) (Secondary), Mean, score on a scale: Dietary Supplement 0.05 +/- 1.05; Placebo 0.05 +/- 0.89
• Change in Attention Bias to Alcohol Score (Secondary), Mean, milliseconds: Dietary Supplement -15.5 +/- 45.3; Placebo 6.63 +/- 30.3
• Change in Alcohol Demand Score (Secondary), Mean, number of drinks: Dietary Supplement -0.15 +/- 1.67; Placebo 0.00 +/- 1.00
• Change in Alcohol Urge Questionnaire Score (Secondary), Mean, score on a scale: Dietary Supplement 3.66 +/- 7.43; Placebo 3.31 +/- 4.37

Adverse events

Time frame: Adverse Events were not assessed prior to randomization. Adverse Events were monitored during each session (up to 6 hours). Additionally, an end of session questionnaire gave participants an opportunity to report any adverse events following each session.

• Study Protocol and Statistical Analysis Plan (PDF, 2024-10-30)
• Informed Consent Form (PDF, 2024-06-26)

• Jimikaye Courtney, PhD, Principal investigator, University of North Carolina, Chapel Hill