Benefits of Alcoholic Hangover Medicine

NCT06126094 | Unknown

• 1 other identifier: BLAM123
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Microbiome

Keywords

Microbiota; Probiotics; Alcohol; Cognitive behaviour

Outcome Measures

Primary Outcomes (1)

• Gut microbiome composition

  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.

  one month

Secondary Outcomes (1)

• the subjective impression of a hangover

  one month

Other Outcomes (1)

• other approach of impression of a hangover

  one month

Study Arms (2)

Probiotic

EXPERIMENTAL

Participants will consume 800 mg of probiotic Myrkl before consuming alcohol in the form of one capsule. (Myrkl, De Fair Medical, Stockholm, Sweden). This formulation contains AB001™, and one capsule (800mg) consists of: * 560 mg of naturally fermented rice bran * Bacillus subtilis * B. coagulans * L-cysteine * dextrin * 36 mg of excipients: magnesium stearate salts, calcium phosphate, potassium phosphate

Dietary Supplement: Myrkl

Placebo

EXPERIMENTAL

The subject who consumed 800 mg of placebo- dextrin (maltodextrin) in the form of two capsules before consuming alcohol.

Dietary Supplement: dextrin

Interventions

Myrkl DIETARY_SUPPLEMENT

The subject of the test will be supplementation with precise probiotic for hangovers (Myrkl, De Fair) in the form of one pill of 800 mg

Probiotic

dextrin DIETARY_SUPPLEMENT

The subject of the test will be supplementation with placebo (maltodextrin) in the form of two pills (each 400 mg)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Both participants should be female twins
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fraternal twins who live and work together

You may not qualify if:

• consumption of other probiotics, antibiotics 30 days before the research
• Inability to drink alcohol

Sponsors & Collaborators

• The Gut Microbiome Center (Centar za crijevni mikrobiom): lead

Study Sites (1)

Gut Microbiome Center

Zagreb, 10000, Croatia

Location

Related Links

• Chronic Uptake of A Probiotic Nutritional Supplement (AB001) Inhibits Absorption of Ethylalcohol in the Intestine Tract - Results from a Randomized Double-blind Crossover Study
• Chronic Uptake of A Probiotic Nutritional Supplement (AB001) Inhibits Absorption of Ethylalcohol in the Intestine Tract - Results from a Randomized Double-blind Crossover Study

MeSH Terms

Interventions

Dextrins

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Andrija Karačić, dr.med

  Centar za crijevni mikrobiom

  STUDY DIRECTOR

Central Study Contacts

Andrija Karačić, dr.med

CONTACT

+385981373344; andrija@ccm.hr

Ira Renko, MS

CONTACT

+385993373343; info@ccm.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The test subjects receive capsules of probiotics and palcebo 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.

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 13, 2023
• Study Start: October 31, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 20, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)