Benefits of Alcoholic Hangover Medicine Myrkl
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Gut microbiome composition
研究概览
简要总结
Myrkl is advertised as a dietary supplement for use before alcohol consumption that is effective in prevention of side effects during the next day. With this research, the investigators want to determine the impact of the mentioned dietary supplement on the intestinal microbiome. For this purpose, the research was designed in three phases before, during and after the research as a double blind trial. In doing so, the subjects take a stool sample before and after the intervention and during the intervention, fill out questionnaires and undergo cognitive tests. At the same time, they give a blood sample after the intervention. After the results of the analysis are due, the researchers enter the data into the for that the predicted Access table (rel. representation of genera/genera/species, average results by questionnaires). The entered data is processed as part of statistical analysis.
详细描述
A "cure" for an alcoholic hangover has been put on the market, that is, it relieves the symptoms and ailments hangover alcohol (https://www.myrkl.com/). This medicine contains probiotic strains in its formulation (Bacillus subtilis, Bacillus coagulans). Myrkl has been advertised as a dietary supplement for use before alcohol consumption that is effective in prevention of side effects during the next day. The manufacturer claims that after taking Myrkl participants feel fresh even after a "long night". In addition to the probiotics mentioned above, Myrkl also contains L-cysteine and vitamins B12. The formula is said to be activated in the intestines. The manufacturer states that 77 of users are satisfied product and how it is completely natural. It is recommended to take two capsules two hours before consumption alcohol. With this research, the investigators wanted to determine the taxonomic changes within the intestinal microbiome after the intervention. In addition, the investigators wanted to determine changes in the subjective impression of a hangover measured by a validated questionnaires. The research was designed as a double-blind placebo-controlled intervention study twins (controlled for age, sex, cohabitation, genetics).
Before the start of the intervention, the test subjects will be instructed to eat the same diet during the 48 hours before beginning of each intervention. The subjects will keep a food diary for two days in order to accurately evaluated the nutritional status. The key is that both subjects consume the same food in both times before the intervention. The food intake itself is determined by the respondents independently.
After the intervention, the respondents will fill out a selection of questionnaires created in the form using the link a special online document (Project BLAM, Forms, Microsoft, USA) that will evaluate theirs alcoholic hangover. In order to evaluate the dynamics of the hangover, the test subject will again every 2 hours fill out the questionnaire (6 evaluations in total - waking up, 2, 4, 6, 8 and 10 hours after waking up). The result of each questionnaire is obtained by calculating the arithmetic mean of all answers (0-5, 0-10). Using all questionnaire was approved by the publisher and the English version will be used. Questionnaires were used https://forms.office.com/Pages/DesignPageV2.aspx subpage=design&FormId=hN0190t4UESOZ73jM ACw9LJ5ROlYHHVMuwYZ6ti3GaRUOEZEUVhSNDlPVjMwT1ZJVUFWTjQ3QldYRC4u&Token=fcda6871a b5d4009b779536b561d8dfb :
- Alcohol Hangover Questionnaire (AHQ)
- Alcohol Hangover Severity Scale (AHSS)
Materials The subject of the test will be supplementation with a precise probiotic for hangovers (Myrkl, De Fair
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
The test subjects receive capsules of probiotics and palceb in marked bags and take one or the other arbitrarily without being told what is in which bag. Likewise, the researchers do not know whether the subjects took the probiotic or the placebo
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •fraternal twins who live and work together
排除标准
- •consumption of other probiotics, antibiotics 30 days before the research
- •Inability to drink alcohol
结局指标
主要结局
Gut microbiome composition
时间窗: one month
The impact of Myrkl on gut microbiome shall assessed through monitoring of relative taxonomic abundance of bacteria that compose gut microbiota from samples taken day before the intervention and after the intervention. The composition of the intestinal microbiota will be determined by sequencing the 16s rRNA bacteria in the stool sample. Subjects take a sample with a sterile cotton swab by wiping stool with toilet paper in their home on a given day research. The sample is stored in a tube with a buffer liquid so that the sample can be stored and transported at room temperature temperature. The test sample is transported by air to the laboratory of Biomes NGS Gesellschaft mit beschränkter Haftung, Wildau, Germany.
次要结局
- the subjective impression of a hangover(one month)