NCT06576674

Satiety and Alcohol Challenge

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alcohol Drinking

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary Fiber + Green Tea Extract	10g fiber + 750mg green tea supplement will be administered at experimental arm
OTHER	Alcohol	alcohol administered up to a target BAC 0.06g/dL during lab sessions
OTHER	Aspartame Placebo Supplement	Aspartame sweetener mixed with water + aspartame capsule

Timeline

• Start date: 2024-09-03
• Primary completion: 2025-04-09
• Completion: 2025-04-09
• First posted: 2024-08-29
• Last updated: 2025-12-05
• Results posted: 2025-12-05

Locations

1 site across 1 country: United States