Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06126094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-10-31
Brief Title:
Benefits of Alcoholic Hangover Medicine
Sponsor:
The Gut Microbiome Center Centar za crijevni mikrobiom
Organization:
The Gut Microbiome Center Centar za crijevni mikrobiom
Study Overview
Official Title:
Benefits of Alcoholic Hangover Medicine Myrkl
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLAM
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 generageneraspecies average results by questionnaires The entered data is processed as part of statistical analysis
Detailed Description:
A cure for an alcoholic hangover has been put on the market that is it relieves the symptoms and ailments hangover alcohol httpswwwmyrklcom 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 httpsformsofficecomPagesDesignPageV2aspx subpagedesignampFormIdhN0190t4UESOZ73jM ACw9LJ5ROlYHHVMuwYZ6ti3GaRUOEZEUVhSNDlPVjMwT1ZJVUFWTjQ3QldYRC4uampTokenfcda6871a 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
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 The CFU per strain in the formulation is minimal ask the manufacturer The probiotic comes in capsule form blister stored at room temperature An 800 mg capsule containing dextrin maltodextrin will be used for the placebo Its a placebo dose also two capsules of 800 mg each
The recommended intake will be two capsules exactly two hours before alcohol consumption Control entry will be through a video diary
Methods Analyzes of the intestinal microbiome Since the impact of probiotics on the intestinal microbiome will be measured before and after the investigated intervention two analyzes of the intestinal microbiome will be carried out on Day 0 ie on the day of the start of the intervention and Day 1 the day after the intervention The BIOMES sampling kit will be used for the analysis and intestpro The analysis will be performed on a sample of the first morning stool that the test subjects will take independently in home conditions Day 0 and Day 1 Samples will be delivered to the companys laboratory by logistics service BOMES BIOMES GmbH Wildau Germany where next-generation sequencing of 16s will be performed ribosomal RNA and bioinformatic analysis of the results review of taxonomy and functionality These results will be delivered to the researchers
Statistical analysis Statistical data processing will analyze the changes in both test subjects B1 and B2 taking taking into account whether the intervention was verum V or placebo P Upon maturity descriptive and inferential statistics will be made of the results using the appropriate program Statistica Palo Alto USA For normally distributed data use the Kolmogorov-Smirnoff test will be the average and standard deviation and for the second group the median and percentiles To analyze the hypothesis treatment Mann-Whitney test and paired t-test will be used Statistically significant will be considered p- values less than 005
The research is divided into three phases - before the intervention intervention and after interventions Alcohol is administered during the intervention The respondents choose the drink they want consumed in two categories welcome drink - žestice brandy liqueur wormwood evening drink - gemišt wine beer gin and tonic juice and juice
Before intervention
the test subjects took the tests and research material at the Sky Office reception
48 hours before the intervention they monitor their diet through a diary
both test subjects eat absolutely identical food before each intervention
on Day 0 they take the first stool sample test A test C ideally the morning stoolthe first stool
do not consume any alcohol
two hours before the planned intervention say 630 pm that means around 430 pm they take a capsule with 1 dl water
Intervention
the subjects come to the recording on Day 0 around 1800 in the CCM area the conference room
from 1800 to 1830 is preparation for recording
at 630 pm the first sip of alcohol follows - a welcome drink zestica liqueur
around 640 pm the drinks of the evening follow gemišt gin and tonic beer wine
the first interview follows in terms of checking the degree of intoxication cognitive tests 1-25quiz
around 700 pm the first cut follows - a welcome drink
around 710 pm another drink in the evening
a second conversation follows in terms of checking the degree of intoxication cognitive tests 1-25quiz
during the second interview the interviewees have the opportunity to eat something small mealsandwich
around 1910 the last drink of the evening goes possibly and a welcome drink
a third interview follows in terms of checking the degree of intoxication cognitive tests 1-25quiz
Human Lab takes a blood sample to determine blood ethanol which CCM employees will take to HKA KBSD same evening immediately
After the intervention
after waking up and then within two hours the subjects fill out the questionnaire httpsformsofficecomPagesResponsePageaspxidhN0190t4UESOZ73jMACw9LJ5ROlYH HVMuwYZ6ti3GaRUOEZEUVhSNDlPVjMwT1ZJVUFWTjQ3QldYRC4u
the morning stool or the first stool after the intervention should be sampled on Day 1
on Day 1 around 1800 arrival for filming at the same place
from 1800 to 1900 a conversation about how they feel and whether they think they received a placebo or a probiotic
After the end of the cycle and the arrival of the results of the analysis the researchers enter the data into the for that predicted Access table rel representation of generageneraspecies average results by questionnaires The entered data is processed as part of the statistical analysis in the previously explained manner In these last steps student research assistants may be involved
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 httpsformsofficecomPagesDesignPageV2aspx subpagedesignampFormIdhN0190t4UESOZ73jM ACw9LJ5ROlYHHVMuwYZ6ti3GaRUOEZEUVhSNDlPVjMwT1ZJVUFWTjQ3QldYRC4uampTokenfcda6871a 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
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 The CFU per strain in the formulation is minimal ask the manufacturer The probiotic comes in capsule form blister stored at room temperature An 800 mg capsule containing dextrin maltodextrin will be used for the placebo Its a placebo dose also two capsules of 800 mg each
The recommended intake will be two capsules exactly two hours before alcohol consumption Control entry will be through a video diary
Methods Analyzes of the intestinal microbiome Since the impact of probiotics on the intestinal microbiome will be measured before and after the investigated intervention two analyzes of the intestinal microbiome will be carried out on Day 0 ie on the day of the start of the intervention and Day 1 the day after the intervention The BIOMES sampling kit will be used for the analysis and intestpro The analysis will be performed on a sample of the first morning stool that the test subjects will take independently in home conditions Day 0 and Day 1 Samples will be delivered to the companys laboratory by logistics service BOMES BIOMES GmbH Wildau Germany where next-generation sequencing of 16s will be performed ribosomal RNA and bioinformatic analysis of the results review of taxonomy and functionality These results will be delivered to the researchers
Statistical analysis Statistical data processing will analyze the changes in both test subjects B1 and B2 taking taking into account whether the intervention was verum V or placebo P Upon maturity descriptive and inferential statistics will be made of the results using the appropriate program Statistica Palo Alto USA For normally distributed data use the Kolmogorov-Smirnoff test will be the average and standard deviation and for the second group the median and percentiles To analyze the hypothesis treatment Mann-Whitney test and paired t-test will be used Statistically significant will be considered p- values less than 005
The research is divided into three phases - before the intervention intervention and after interventions Alcohol is administered during the intervention The respondents choose the drink they want consumed in two categories welcome drink - žestice brandy liqueur wormwood evening drink - gemišt wine beer gin and tonic juice and juice
Before intervention
the test subjects took the tests and research material at the Sky Office reception
48 hours before the intervention they monitor their diet through a diary
both test subjects eat absolutely identical food before each intervention
on Day 0 they take the first stool sample test A test C ideally the morning stoolthe first stool
do not consume any alcohol
two hours before the planned intervention say 630 pm that means around 430 pm they take a capsule with 1 dl water
Intervention
the subjects come to the recording on Day 0 around 1800 in the CCM area the conference room
from 1800 to 1830 is preparation for recording
at 630 pm the first sip of alcohol follows - a welcome drink zestica liqueur
around 640 pm the drinks of the evening follow gemišt gin and tonic beer wine
the first interview follows in terms of checking the degree of intoxication cognitive tests 1-25quiz
around 700 pm the first cut follows - a welcome drink
around 710 pm another drink in the evening
a second conversation follows in terms of checking the degree of intoxication cognitive tests 1-25quiz
during the second interview the interviewees have the opportunity to eat something small mealsandwich
around 1910 the last drink of the evening goes possibly and a welcome drink
a third interview follows in terms of checking the degree of intoxication cognitive tests 1-25quiz
Human Lab takes a blood sample to determine blood ethanol which CCM employees will take to HKA KBSD same evening immediately
After the intervention
after waking up and then within two hours the subjects fill out the questionnaire httpsformsofficecomPagesResponsePageaspxidhN0190t4UESOZ73jMACw9LJ5ROlYH HVMuwYZ6ti3GaRUOEZEUVhSNDlPVjMwT1ZJVUFWTjQ3QldYRC4u
the morning stool or the first stool after the intervention should be sampled on Day 1
on Day 1 around 1800 arrival for filming at the same place
from 1800 to 1900 a conversation about how they feel and whether they think they received a placebo or a probiotic
After the end of the cycle and the arrival of the results of the analysis the researchers enter the data into the for that predicted Access table rel representation of generageneraspecies average results by questionnaires The entered data is processed as part of the statistical analysis in the previously explained manner In these last steps student research assistants may be involved
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None