Satiety and Alcohol Challenge

NCT06576674 | Completed Results

• 1 other identifier: 24-1095
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Drinking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  baseline to 60 minutes

• Change in Subjective Stimulation (Biphasic Alcohol Effects Scale)

  baseline to 60 minutes

• Change in Attention Bias to Alcohol Score

  30 minutes after alcohol administration

• Change in Alcohol Demand Score

  baseline to 60 minutes

• Change in Alcohol Urge Questionnaire Score

  baseline to 60 minutes

Study Arms (2)

dietary supplement, then placebo

EXPERIMENTAL

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; Other: Alcohol; Other: Aspartame Placebo Supplement

placebo, then dietary supplement

EXPERIMENTAL

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; Other: Alcohol; Other: Aspartame Placebo Supplement

Interventions

Aspartame Placebo Supplement OTHER

Aspartame sweetener mixed with water + aspartame capsule

Also known as: Equal

dietary supplement, then placebo; placebo, then dietary supplement

Dietary Fiber + Green Tea Extract DIETARY_SUPPLEMENT

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

Also known as: Fibersol®-2, decaffeinated green tea extract

dietary supplement, then placebo; placebo, then dietary supplement

Alcohol OTHER

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

Also known as: ethanol (ETOH)

dietary supplement, then placebo; placebo, then dietary supplement

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Research Society on Alcohol: collaborator
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Dietary Fiber; Tea; Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Alcohols; Organic Chemicals

Results Point of Contact

• Title: Michael Bremmer, PhD
• Organization: University of North Carolina at Chapel Hill

mbremmer@unc.edu

301-827-0566

Study Officials

• Jimikaye Courtney, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participant will be blinded to the session order in which they receive either the dietary supplements (fiber and green tea) or a placebo.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: within-subjects placebo-controlled design

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: September 3, 2024
• Primary Completion: April 9, 2025
• Study Completion: April 9, 2025
• Last Updated: December 5, 2025
• Results First Posted: December 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)