Satiety and Alcohol Challenge
NCT Number: NCT06576674
Acronym: SatTAC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alcohol Drinking
Interventions: DIETARY_SUPPLEMENT: Dietary Fiber + Green Tea Extract|OTHER: Alcohol|OTHER: Aspartame Placebo Supplement
Sponsor: University of North Carolina, Chapel Hill
Collaborators: Research Society on Alcohol (RSA)|North Carolina Translational and Clinical Sciences Institute
Sex: ALL
Age: ADULT
Enrollment: 55
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08
Completion Date: 2025-07
Locations: University of North Carolina, Chapel Hill, North Carolina, 27599, United States

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.

Primary Outcome Measures: Change in alcohol specific satiety score, 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., baseline to 60 minutes
Secondary Outcome Measures: Change in SEAS Score, ues representing greater alcohol-specific satiety.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., baseline to 60 minutes|Change in BAES Score, 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., baseline to 60 minutes|Attention bias to alcohol, 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., 30 minutes after alcohol administration|Change in alcohol demand score, The alcohol purchase task (APT) measures the hypothetical behavioral economic demand for alcohol at 14 different price points. Willingness to purchase a greater relative number of drinks at increasing price points indicates greater alcohol demand., baseline to 60 minutes|Change in AUQ score, 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., baseline to 60 minutes