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Clinical Trials/NCT06576674
NCT06576674CompletedNot Applicable

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

University of North Carolina, Chapel Hill2 sites in 1 country64 target enrollmentStarted: September 3, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
64
Locations
2
Primary Endpoint
Change in Alcohol Specific Satiety Score

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Masking Description

participant will be blinded to the session order in which they receive either the dietary supplements (fiber and green tea) or a placebo.

Eligibility Criteria

Ages
21 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

  • 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 Alcohol Urge Questionnaire Score(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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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