Effect of Consumption of Different Foods on the Pharmacokinetics of a Small Dose of Ethanol: A Randomized Controlled, Clinical Trial in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Maximal blood alcohol concentration (BAC Cmax)
研究概览
简要总结
Alcohol consumption is prevalent and frequently excessive and its use poses a major risk to both personal and public health. In the U.S., every month over 25% of adults and 40% of college students drink until their blood alcohol concentration (BAC) exceeds the legal limit of 0.08% and there is a great unmet need for interventions to help individuals better manage their BACs. Zeno Functional Foods has developed a protein bar, SOBAR, with the aim to control alcohol absorption when eaten prior to drinking. It is hypothesized that the SOBAR will slow stomach emptying resulting in a comparatively diminished peak BAC as well as a more stable BAC-time profile that is both safer and more pleasurable for the drinker.
详细描述
Alcohol consumption is not a new phenomenon; it has been part of human culture since the start of recorded time. As a consequence, advice on alcohol consumption is also not new with probably the best-known one by the Greek playwright Eubulus:
"Three bowls do I mix for the temperate: one to health, which they empty first; the second to love and pleasure; the third to sleep. When this bowl is drunk up, wise guests go home. The fourth bowl is ours no longer, but belongs to violence; the fifth to uproar; the sixth to drunken revel; the seventh to black eyes; the eighth is the policeman's; the ninth belongs to biliousness, and the tenth to madness and the hurling of furniture".
Moderate alcohol consumption appears to provide some protection against certain illnesses, including heart disease and diabetes, however counterbalancing this is that, simultaneously, alcohol consumption will also increase the risk of other serious diseases (Bagnardi et al, 2004; Di Castelnouvo et al, 2006; Djousse and Gaziano, 2008; Rehm et al, 2006; Standridge et al, 2004) as well as injury (Taylor et al, 2010). As the amount of alcohol usually consumed in a day increases, so does the risk of a wide range of physical and mental illnesses, including a number of cancers, liver disease and depression (Rehm et al, 2006).
As a consequence, the current advice as given by the USDA is not to consume alcohol at all and, when alcohol is consumed, it is to be done in moderation within a healthy eating pattern. These recommendations are consistent with the most recent review of global alcohol usage and the risks it poses (GBD 2016 Alcohol Collaborators, 2018).
Despite these guidelines, alcohol consumption is prevalent and frequently excessive and its use poses a major risk to both personal and public health. In the U.S., every month over 25% of adults and 40% of college students drink until their blood alcohol concentration (BAC) exceeds the legal limit of 0.08% and there is a great unmet need for interventions to help individuals better manage their BACs (www.niaaa.nih.gov/alcohol-health).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant, non-lactating females, 25-65 years of age, inclusive
- •Body mass index 20 - 30 kg/m2 inclusive
- •Blood pressure: systolic < 140 and diastolic <95 mmHg.
- •Social drinkers; average 2 or fewer drinks per day and have not had an episode of "binge drinking" over the previous 30 days. Binge drinking is defined has having 4 or more drinks (for women) / 5 or more drinks (for men) over the course of 2 hours. One drink is defined as either 5oz wine, 341ml of beer/cider or 1.5 oz. of distilled 80-proof spirit.
- •Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and consume the standard meal provided by GI Labs the evening before each test day
- •Subject is willing to abstain from strenuous exercise, alcoholic drinks, and cannabis use 24hours before study visits.
- •Subject is willing to refrain from driving or operating any vehicle when leaving GI Labs after the test visit
- •Subject is willing to sign on each test day a statement acknowledging that the subject is aware that he/she has consumed alcohol that morning
- •Willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements or caffeine. Failure to comply will result in a rescheduled test visit.
- •No major illness or surgery requiring hospitalization within 3 months of the first study visit after screening.
- •No history of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease.
- •Subjects must be eligible to receive income in Canada and be covered by a health insurance such as OHIP.
- •Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
- •Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
- •Female subjects are willing to use a contraceptive method to avoid pregnancy during the study period. Willing to take a urine pregnancy test the day of each study.
排除标准
- •Failure to meet all the inclusion criteria
- •Known history of gastrointestinal, liver, kidney, or cardiovascular (including but not limited to atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), and pulmonary disease
- •History of mental disease, seizures, use or abuse of psychoactive medications (including but not limited to cocaine, amphetamines, opiates, sedatives, benzodiazepines, and hallucinogens) or any medication or condition which might, in the opinion of Dr. Wolever, the medical director of GI labs, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- •Use of antibiotics within 4 weeks of start of study.
- •History or diagnosis of alcohol use disorder or binge drinking (4 or more drinks for women and 5 or more drinks for men within a 2-hour window) as defined by the current NIAAA guidelines.
- •Major trauma or surgical event within 3 months of screening.
- •Of East Asian descent or having a history of alcohol induced flushing reaction.
- •Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
- •Known intolerance, sensitivity or allergy to any ingredients in the study products.
- •Extreme dietary habits as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc).
- •Change in body weight of >3.5kg within 4 weeks of the screening visit.
- •Presence of any signs or symptoms of an active infection within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment (i.e. antibiotic therapy) has been completed at least 5 d prior to each test visit.
- •History of cancer in the prior two years, except for non-melanoma skin cancer.
结局指标
主要结局
Maximal blood alcohol concentration (BAC Cmax)
时间窗: 90 minutes
As measured indirectly using a breathalyzer, the level of peak BAC during the experimental timeframe.
次要结局
- Incremental area under the curve at 60min (IAUC 60)(60 minutes)
- Incremental area under the curve at 90min (IAUC 90)(90 minutes)
- Time to reach maximal blood alcohol concentration (BAC Tmax)(90 minutes)