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Completed

NCT Number: NCT06576674

Satiety and Alcohol Challenge

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.

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Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Fiber + Green Tea Extract

Dietary Supplement

10g fiber + 750mg green tea supplement will be administered at experimental arm

Other names: Fibersol®-2, decaffeinated green tea extract

Alcohol

Other

alcohol administered up to a target BAC 0.06g/dL during lab sessions

Other names: ethanol (ETOH)

Aspartame Placebo Supplement

Other

Aspartame sweetener mixed with water + aspartame capsule

Other names: Equal

Primary outcomes

  1. Change in Alcohol Specific Satiety Score

    Time frame: 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

  1. Change in Positive Affect Based on Subjective Effects of Alcohol Scale Score

    Time frame: 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.

  2. Change in Subjective Stimulation (Biphasic Alcohol Effects Scale)

    Time frame: 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.

  3. Change in Attention Bias to Alcohol Score

    Time frame: 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.

  4. Change in Alcohol Demand Score

    Time frame: 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.

  5. Change in Alcohol Urge Questionnaire Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Translational and Clinical Sciences Institute
  • Research Society on Alcohol

Registry information

Official study title

Effect of a Dietary Supplement on Satiety and Acute Responses to Laboratory Alcohol Challenge

Acronym: SatTAC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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