Clinical trial NCT06576674: Satiety and Alcohol Challenge
Official title: Effect of a Dietary Supplement on Satiety and Acute Responses to Laboratory Alcohol Challenge
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Research Society on Alcohol
name: North Carolina Translational and Clinical Sciences Institute
First posted: 2024-08-29
Enrollment: 55
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: within-subjects placebo-controlled design
Primary purpose: BASIC_SCIENCE

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 30mg% 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in alcohol specific satiety score
timeFrame: baseline to 60 minutes
Secondary outcomes:
measure: Change in SEAS Score
timeFrame: baseline to 60 minutes
measure: Change in BAES Score
timeFrame: baseline to 60 minutes
measure: Attention bias to alcohol
timeFrame: 30 minutes after alcohol administration
measure: Change in alcohol demand score
timeFrame: baseline to 60 minutes
measure: Change in AUQ score
timeFrame: baseline to 60 minutes
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jimikaye Courtney, PhD
role: PRINCIPAL_INVESTIGATOR
References: