Addiction, AlcoholNCT05134675
Does Homebrewing Beer Affect Urinary Tract Symptoms and Bladder Cancer
An observational study of Addiction, Alcohol and Urinary Tract Disease, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, investigators aim to reveal the harmful effects of increasing consumption of homemade beer in recent years on the urinary tract. The high amount of carbonyl compounds in the content of homemade beer has been proven by studies. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Addiction, Alcohol, Urinary Tract Disease
- What is being tested?
- Homemade beer
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jun 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who consume and do not consume homemade beer will be included in our study. Homemade beer consumption definition, for more than 3 months; regular consumption of 1 or more home-made beer in 1 week for women was considered as 2 or more home-made beer consumption in 1 week for men.
Who may be able to join
- Homemade beer consumption and not consumption
Who cannot join
- Bleeding disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, Altindag, 06230
About this study
In this study, investigators aim to reveal the harmful effects of increasing consumption of homemade beer in recent years on the urinary tract. The high amount of carbonyl compounds in the content of homemade beer has been proven by studies. In this study, which will be conducted in the form of a questionnaire, it is aimed to evaluate the effects of the consumption of homemade beer and the long-term exposure of the urinary system to carbonyl compounds.
Read the detailed description
Homemade and craft beers are perceived as a popular alternative to beers produced on a larger scale in recent years, due to the choice of consumers according to different taste preferences and the raw materials used for brewing. According to nationally representative survey data from the American Homebrewers Association (AHA), the U.S. had an estimated 1.1 million homebrew brewers in 2017, with annual homebrew beer production in excess of 1.4 million barrels (about 1% of annual U.S. beer production). Again in 2017, 40% of home brewers started production within the last 4 years. Due to the prohibitions that have arisen due to the pandemic all over the world, the production of homemade beer has reached its peak today. In recent years, home-made beer consumption has gained popularity in parallel with low-alcohol and non-alcoholic beers, which are prone to microbial spoilage, due to the ease of access to the material, financial returns and hobby acquisition.
Homemade beer is typically more susceptible to spoilage as it is not pasteurized or sterile filtered. The microbiota, which is associated with organic raw materials, fruits, herbs, honey, spices and vegetables, and non-traditional starch-rich ingredients added to produce different aromas and flavors, increases the risk of spoilage. In addition, home brewers often lack the advantages of a sophisticated microbiological laboratory, and optimal temperature control during brewing and storage cannot be guaranteed. In addition to the fermentation conditions (time and temperature), yeast strain and mash composition (types of grain used in malting, mashing/boiling conditions) can also affect the chemical profile of beer, resulting in a wide variety of components. Carbonyl compounds [acetaldehyde, acrolein, ethyl carbamate (EC) and formaldehyde] are particularly toxic compounds that can occur. Acetaldehyde, acrolein, and formaldehyde are highly reactive due to their electrophilic nature, so they easily react with biological nucleophilic targets such as proteins, RNA, and DNA.
- Conditions
- Addiction, Alcohol, Urinary Tract Disease
- Being tested
- Homemade beer
- Keywords
- beer, urinary tract
- Medical subject headings
- Alcoholism, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homemade beerDietary supplement
Also called Homebrewing beer
The data of patients who consume and do not consume homemade beer will be cross-sectionally evaluated and compared.
| Study group | Role | What they receive |
|---|---|---|
| Consumption | Patients consuming homemade beer Receives: Dietary Supplement: Homemade beer | |
| Not consumption | Patients are not consuming homemade beer Receives: Dietary Supplement: Homemade beer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of urinary tract symptoms
Rates of urinary tract symptoms who consumed the homemade beer
Measured: 3 months
Rates of bladder cancer
Rates of bladder cancer who consumed the homemade beer
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start16 Jun 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Addiction, AlcoholStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Kaan Yildiz, Ankara Training and Research Hospital
- Investigators
- Ali Kaan Yildiz, Principal investigator, Ankara Training and Resarch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134675
- Sponsor's protocol ID
- CB2021
- Status last verified
- Feb 2022
- First submitted
- 15 Nov 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lachenmeier DW, Przybylski MC, Rehm J. Comparative risk assessment of carcinogens in alcoholic beverages using the margin of exposure approach. Int J Cancer. 2012 Sep 15;131(6):E995-1003. doi: 10.1002/ijc.27553. Epub 2012 Apr 17.
PubMed 22447328
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Homebrewing Beer Affect Urinary Tract Symptoms and Bladder Cancer
- ClinicalTrials.gov ID
- NCT05134675
- Acronym / sponsor ID
- CB2021
- Conditions
- Addiction, Alcohol, Urinary Tract Disease
- Keywords
- beer, urinary tract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 16 Jun 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, investigators aim to reveal the harmful effects of increasing consumption of homemade beer in recent years on the urinary tract. The high amount of carbonyl compounds in the content of homemade beer has been proven by studies. In this study, which will be conducted in the form of a questionnaire, it is aimed to evaluate the effects of the consumption of homemade beer and the long-term exposure of the urinary system to carbonyl compounds.
Detailed description
Homemade and craft beers are perceived as a popular alternative to beers produced on a larger scale in recent years, due to the choice of consumers according to different taste preferences and the raw materials used for brewing. According to nationally representative survey data from the American Homebrewers Association (AHA), the U.S. had an estimated 1.1 million homebrew brewers in 2017, with annual homebrew beer production in excess of 1.4 million barrels (about 1% of annual U.S. beer production). Again in 2017, 40% of home brewers started production within the last 4 years. Due to the prohibitions that have arisen due to the pandemic all over the world, the production of homemade beer has reached its peak today. In recent years, home-made beer consumption has gained popularity in parallel with low-alcohol and non-alcoholic beers, which are prone to microbial spoilage, due to the ease of access to the material, financial returns and hobby acquisition.
Homemade beer is typically more susceptible to spoilage as it is not pasteurized or sterile filtered. The microbiota, which is associated with organic raw materials, fruits, herbs, honey, spices and vegetables, and non-traditional starch-rich ingredients added to produce different aromas and flavors, increases the risk of spoilage. In addition, home brewers often lack the advantages of a sophisticated microbiological laboratory, and optimal temperature control during brewing and storage cannot be guaranteed. In addition to the fermentation conditions (time and temperature), yeast strain and mash composition (types of grain used in malting, mashing/boiling conditions) can also affect the chemical profile of beer, resulting in a wide variety of components. Carbonyl compounds [acetaldehyde, acrolein, ethyl carbamate (EC) and formaldehyde] are particularly toxic compounds that can occur. Acetaldehyde, acrolein, and formaldehyde are highly reactive due to their electrophilic nature, so they easily react with biological nucleophilic targets such as proteins, RNA, and DNA.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Consumption | – | Dietary Supplement: Homemade beerPatients consuming homemade beer |
| Not consumption | – | Dietary Supplement: Homemade beerPatients are not consuming homemade beer |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who consume and do not consume homemade beer will be included in our study. Homemade beer consumption definition, for more than 3 months; regular consumption of 1 or more home-made beer in 1 week for women was considered as 2 or more home-made beer consumption in 1 week for men.
Key inclusion criteria (1 listed)
- Homemade beer consumption and not consumption
Key exclusion criteria (1 listed)
- Bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homemade beerAlso: Homebrewing beerThe data of patients who consume and do not consume homemade beer will be cross-sectionally evaluated and compared. | Dietary supplement | Consumption, Not consumption |
Primary outcome
Rates of urinary tract symptoms
Time frame: 3 months
Rates of urinary tract symptoms who consumed the homemade beer
Rates of bladder cancer
Time frame: 3 months
Rates of bladder cancer who consumed the homemade beer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Results publication: PubMed 22447328Lachenmeier DW, Przybylski MC, Rehm J. Comparative risk assessment of carcinogens in alcoholic beverages using the margin of exposure approach. Int J Cancer. 2012 Sep 15;131(6):E995-1003. doi: 10.1002/ijc.27553. Epub 2012 Apr 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Kaan Yildiz principal investigator
Ankara Training and Resarch Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Addiction, Alcohol and Urinary Tract Disease, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Kaan Yildiz (+90 554 773 16 96, alikaanyildiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of urinary tract symptoms (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05134675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.