Acute Effects of Ketone Supplementation on Subjective and Objective Responses to Alcohol in Healthy Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Acute effects of breath/blood alcohol levels in response to ketone supplement verse placebo
研究概览
简要总结
This is a single blinded, randomized trial to evaluate the immediate subjective and objective effects of alcohol after a dose ketone supplement compared to a placebo in 10 health volunteers. Subjects will complete 2 lab visits where they consume a dose of alcohol (based on weight), to bring their breath alcohol concentration to about 0.050%. Participants will randomly receive ketone supplement at one lab and the placebo at the next lab.
详细描述
The purpose of the study is to evaluate the immediate subjective and objective effects of alcohol after consuming a ketone supplement beverage, compared to a placebo beverage (an inactive substance). Participants will not know which lab they receive the ketone drink, however they will be asked to drink an alcohol beverage (based on weight), to bring breath alcohol concentration (BrAC) to about 0.050% at each lab visit.
The goal of the study is to see how measure subjective effects of alcohol, once after drinking the ketone supplement and once after drinking a placebo beverage. The study will use questionnaires, blood, and breath alcohol tests to see how subjects body and brain experience alcohol. The study is also interested in if the ketone supplement makes people want to drink alcohol more or less.
Consent and Screening Session (approximately 3 hrs)
The following will occur at the screening session, following signed consent:
- First, subjects will be asked to show a legal photo ID and then undergo a breathalyzer test to ensure that they are able to make a well-reasoned decision about whether or not to participate in the study. The BrAC must be at 0.000% to complete this visit.
- Demographic information, such as date of birth, age, biological sex, marital status, education, race, and ethnicity will be collected.
- Subjects will be asked to provide current information about address and contact information to register them as a patient at the University of Pennsylvania, if they have not been a patient here before.
- Approximately 2 tablespoons of blood for standard laboratory tests will be drawn. It is possible that bloodwork will need to be repeated due to unforeseen events (abnormal findings or potential lab errors).
- Subject's will be asked to provide a urine sample for routine urinalysis, drug screen, and a pregnancy test in women who are able to become pregnant.
- Study personnel will measure vital signs (blood pressure and pulse), weight, and height. Subject's will be asked to complete a questionnaire about current and past medical history and any medications currently taking.
- Study personnel will complete a brief psychiatric interview and ask about alcohol and cigarette use over the past 90 days.
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
Single blind
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willingness to provide signed, informed consent and commit to completing the alcohol lab studies.
- •All subjects must report at least one occasion in the prior month of drinking at least 2 drinks on a single day.
排除标准
- •Unwilling or unable to refrain from use, within 24 hours of alcohol lab procedures, psychoactive medications or medications that may affect study results.
- •Current DSM-5 diagnosis of a major psychiatric disorder (other than nicotine use disorders, or marijuana use disorders) (identified by clinical examination or the structured interview) that could interfere with study participation or make it hazardous for the subject.
- •Currently taking a medication that could interfere with study participation or make it hazardous for the subject to participate. (e.g., anticholinergics; antipsychotics; lithium; psychotropic drugs not otherwise specified)
- •Positive urine drug screen positive for all substances but marijuana on study visits (may be repeated once and if the result is negative on repeat it is not exclusionary).
- •A baseline breath alcohol concentration of greater than 0.00% on study visit prior to alcohol tolerance test
- •A current, clinically significant physical disease or abnormality on the basis of medical history, or routine laboratory evaluation that can impact brain function, the use of a ketone supplement or the use of alcohol (e.g., epilepsy, diabetes, irritable bowel syndrome, Crohn's disease, liver disease, kidney disease, kidney stones, chronic metabolic acidosis or a cardiomyopathy as determined by history and clinical exam).
- •Currently suffering from or with a history of stroke and/or stroke related spasticity.
- •Head trauma with loss of consciousness for more than 30 minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI. (self-report, medical history).
- •Weight greater than 225lbs (Need to cap amount of alcohol give based on weight to individuals).
- •Judged by the principal investigator or his designee to be an unsuitable candidate for study participation.
研究组 & 干预措施
ketone supplement
Subjects will drink single dose of ketone supplement 25g
干预措施: Alcohol Beverage (Other)
Placebo beverage
Subjects will drink single dose of placebo beverage that will look and taste the same as ketone supplement.
干预措施: Alcohol Beverage (Other)
ketone supplement
Subjects will drink single dose of ketone supplement 25g
干预措施: Ketone Supplement (Dietary Supplement)
结局指标
主要结局
Acute effects of breath/blood alcohol levels in response to ketone supplement verse placebo
时间窗: 4 hours
Change in breath/blood alcohol levels (grams per 210 Liters of breath) in response to ketone supplement verse placebo
次要结局
- Acute effects of subjective reports of intoxication and alcohol craving in response to ketone supplement verse placebo after alcohol drinks.(4 hours)