Effects of Ketogenic Diet on Alcohol Intoxication
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
The research study is being conducted to better understand the effects of ketosis on brain functioning and the acute effects of alcohol. Participants will be asked to undergo ~4 weeks of ketogenic diet intervention. The study involves three lab visits: Lab 1 before starting the diet, Lab 2 after about 2 weeks after starting the diet, and Lab 3 after being on the diet for 4 weeks. All of the labs will include an alcohol tolerance test, and blood draws. Lab 1 and Lab 3 will also include an Magnetic resonance imaging scan. Due to scheduling, study procedures at 2 and 4 weeks may occur +/- 3 days. Magnetic resonance imaging (MRI) of the brain will measure levels of nicotinamide adenine dinucleotide (NAD) (a coenzyme that is important for energy metabolism), lactate (a metabolite produced during energy metabolism), and neurotransmitters glutamate and GABA. Alcohol tolerance will be tested using a dose of alcohol (approximately 4-5 alcohol beverages) to will elevate breath alcohol levels to approximately 0.08% to measure the acute effects of alcohol. Blood samples will be collected to measure varying metabolites.
详细描述
Consent and Screening Session (approximately 4 hours).
The following will occur at this visit. The visit may be completed on more than one day at the CSA following signed consent:
- Participants 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 breath alcohol level must be 0.000% to sign the consent form.
- Participants will be asked to provide demographic information, including current address to be registered as a patient at the University of Pennsylvania.
- A clinician will perform a medical history and physical examination. Trained study staff will draw a total of approximately 3 tablespoons (44 mL) of blood for standard laboratory tests and genetic analysis.
- A urine sample is required for routine urinalysis, drug screen, ketone levels, and a pregnancy test for woman who are able to become pregnant.
- Study personnel will measure vital signs (blood pressure and pulse), weight, and height.
- Study personnel will complete a brief psychiatric interview record alcohol and cigarette use over the past 90 days.
- Participants must complete a screening evaluation form in advance of the MRI exam for the presence of medical implants or other foreign bodies that could pose an injury when undergoing MRI.
Staff will call participants within 5 business days of completing the screening visit to confirm whether study eligibility and schedule the rest of the study visits.
Dietary Intervention (4 weeks each)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Age 21 years to 50 years old.
- •Willingness to provide signed, informed consent and commit to completing study procedures. Reported on at least one day in the month prior to consent of consuming 2 or more standard alcohol drinks on a single day.
排除标准
- •Unwilling or unable to refrain from use, within 24 hours of the alcohol lab procedures, psychoactive medications or medication that may affect study results.
- •Current DSM-5 diagnosis of any major psychiatric disorder (other than nicotine use disorders, or marijuana use disorders) as identified by clinical examination or structured interview that could interfere with study participation or make it hazardous for the subject.
- •Currently taking medication(s) 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 at screening or study visits (may be repeated once and if the result is negative on repeat, it is not exclusionary).
- •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, administration of ketogenic diet, 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 has 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, inter-cranial bleeding or abnormal MRI (self-report, medical history).
- •Weight greater than 225lbs (Need to cap amount of alcohol given based on weight to individuals).
- •Females who are pregnant or breast-feeding
- •Contraindication to MRI, including presence of ferromagnetic objects, claustrophobia or fear of enclosed, medical conditions that prevent subjects from lying comfortably flat on his/ her back for up to 2 hrs.
研究组 & 干预措施
Ketogenic diet
4 week ketogenic diet intervention
干预措施: Ketogenic diet (Other)