Effect of a Dietary Supplement on Satiety and Acute Responses to Laboratory Alcohol Challenge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in Alcohol Specific Satiety Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
participant will be blinded to the session order in which they receive either the dietary supplements (fiber and green tea) or a placebo.
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Alcohol Specific Satiety Score
时间窗: 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.
次要结局
- 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)