Satiety and Alcohol Challenge (SatTAC)

University of North Carolina (UNC)

Status: Completed

Conditions: Alcohol Drinking

Treatments: Other: Aspartame Placebo Supplement; Other: Alcohol; Dietary Supplement: Dietary Fiber + Green Tea Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT06576674

24-1095

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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64 participants in 2 patient groups

dietary supplement, then placebo

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Dietary Fiber + Green Tea Extract

Other: Alcohol

Other: Aspartame Placebo Supplement

placebo, then dietary supplement

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Dietary Fiber + Green Tea Extract

Other: Alcohol

Other: Aspartame Placebo Supplement