Clinical trial NCT05134675: Does Homebrewing Beer Affect Urinary Tract Symptoms and Bladder Cancer
Official title: Does Homebrewing Beer Affect Urinary Tract Symptoms and Bladder Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Addiction, Alcohol
Urinary Tract Disease
Keywords: beer
urinary tract
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Homemade beer consumption and not consumption

Exclusion Criteria

* Bleeding disorders

Primary outcomes:
measure: Rates of urinary tract symptoms
timeFrame: 3 months
measure: Rates of bladder cancer
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
state: Altindag
Study officials:
affiliation: Ankara Training and Resarch Hospital
name: Ali Kaan Yildiz
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.