A Single-Center, Open-Label, Crossover Exploratory Study of NatureU Cheers Friends Curcumin on Acute Alcohol Hangover Symptoms in Healthy Adult Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
This was a single-center, open-label, exploratory crossover study evaluating acute hangover symptoms after use of NatureU Cheers Friends Curcumin compared with an active comparator product in healthy adult men. Participants completed two independent test-food sessions separated by at least 48 hours. Sixteen participants were recruited, 12 were screened and enrolled, and 12 were included in the effectiveness analysis. In the control session, participants took Herbsense hangover relief tablets 30 minutes before alcohol intake. In the NatureU Cheers Friends Curcumin session, participants took NatureU Cheers Friends Curcumin 30 minutes before alcohol intake. The main outcome was the Acute Hangover Scale (AHS) assessed the morning after each test session. Safety was monitored during the test procedures.
详细描述
The study was designed as an exploratory human evaluation of a functional food product intended to support post-alcohol hangover relief. Eligible healthy adult male participants completed two independent test-food sessions under researcher supervision. Screening was performed on June 19, 2024, eligible participants were enrolled on June 20, 2024, and the final next-morning questionnaire assessment was completed on June 21, 2024. Participants were instructed not to drink alcohol for 24 hours before each test day and not to eat during the 3 hours before testing. On each test day, participants arrived at the study center at approximately 18:00, completed check-in and baseline assessments including blood pressure, pulse rate, and breath alcohol measurement, and received the assigned test product at approximately 18:30. At approximately 19:00, participants consumed 100 mL of commercially available 52% Chinese baijiu within 10-15 minutes and consumed a standardized meal within 30 minutes. Blood pressure and pulse rate were measured 30, 60, and 120 minutes after alcohol intake. Participants completed the Acute Hangover Scale the next morning after waking. The study was open-label and exploratory, with no masking. Analyses compared AHS scores after NatureU Cheers Friends Curcumin with scores after the comparator product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
盲法说明
The study was open-label with no masking.
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent before the study and understood the study content, procedures, and possible adverse reactions.
- •Healthy adult man aged 20 to 48 years, inclusive.
- •Normal social drinking lifestyle and no alcohol dependence.
- •Aspartate aminotransferase and alanine aminotransferase values within two standard deviations of the normal range.
- •Able to maintain normal healthy routines during the study.
- •Able to avoid other interfering supplements for 2 weeks before and during the study.
- •Abstained from alcohol for 24 hours before the study.
- •Abstained from caffeinated beverages, including coffee, tea, and energy drinks, for 12 hours before the study.
排除标准
- •Known allergy or hypersensitivity to product ingredients, including magnolia bark, milk thistle extract, turmeric, or alcohol.
- •History of multiple drug or food allergies.
- •Acute or chronic inflammatory disease, including influenza A, within the previous month.
- •Hypertension.
- •Participation in any other clinical trial within 1 month before first use of the study product.
- •Clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immune, psychiatric, cardiovascular, cerebrovascular, or metabolic disease within the previous 6 months.
- •Acute illness or concomitant medication use from screening to first use of the study product.
- •Surgery within the previous 3 months.
- •Blood donation or major blood loss greater than 450 mL within the previous 3 months.
- •Difficulty swallowing.
- •Use of prescription or non-prescription medications affecting nutritional supplements or alcohol metabolism.
- •Any other factor judged by the investigator to make participation inappropriate.