Satiety and Alcohol Challenge (SatTAC)

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

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking
• Intervention / Treatment: Dietary supplement: Dietary Fiber + Green Tea Extract; Other: Aspartame Placebo Supplement; Other: Alcohol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dietary supplement, then placebo; Participants receive a dietary supplement at the first study session (10g Fibersol®-2 mixed with water and aspartame sweetener + 725mg decaffeinated green tea extract capsule), and then the next study session they receive the placebo supplement (Aspartame sweetener mixed with water + aspartame capsule). Participants will also receive a drink containing alcohol (vodka + cranberry mixer) on both sessions.	Dietary supplement: Dietary Fiber + Green Tea Extract; 10g fiber + 750mg green tea supplement will be administered at experimental arm; Other Names: Fibersol®-2; decaffeinated green tea extract; Other: Aspartame Placebo Supplement; Aspartame sweetener mixed with water + aspartame capsule; Other Names: Equal; Other: Alcohol; alcohol administered up to a target BAC 0.06g/dL during lab sessions; Other Names: ethanol (ETOH)
Experimental: placebo, then dietary supplement; Participants receive a placebo supplement at the first study session (Aspartame sweetener mixed with water + aspartame capsule), then the next session they receive the dietary supplement (10g Fibersol®-2 mixed with water and aspartame sweetener + 725mg decaffeinated green tea extract capsule). Participants will also receive a drink containing alcohol (vodka + cranberry mixer) on both sessions.	Dietary supplement: Dietary Fiber + Green Tea Extract; 10g fiber + 750mg green tea supplement will be administered at experimental arm; Other Names: Fibersol®-2; decaffeinated green tea extract; Other: Aspartame Placebo Supplement; Aspartame sweetener mixed with water + aspartame capsule; Other Names: Equal; Other: Alcohol; alcohol administered up to a target BAC 0.06g/dL during lab sessions; Other Names: ethanol (ETOH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Change in Positive Affect Based on Subjective Effects of Alcohol Scale Score	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 Subjective Stimulation (Biphasic Alcohol Effects Scale)	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
Change in Attention Bias to Alcohol Score	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 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.	baseline to 60 minutes
Change in Alcohol Urge Questionnaire 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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: North Carolina Translational and Clinical Sciences Institute; Research Society on Alcohol
• Investigators: Principal Investigator: Jimikaye Courtney, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2024
• Primary Completion (Actual): April 9, 2025
• Study Completion (Actual): April 9, 2025

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Behavior; Alcohol Drinking; Organic Chemicals; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Carbohydrates; Carbohydrates; Beverages; Alcohols; Plant Preparations; Biological Products; Complex Mixtures; Ethanol; Dietary Fiber; Tea
• Other Study ID Numbers: 24-1095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: beginning 9 and continuing for 36 months following publication
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No