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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05134675
Other study ID # CB2021
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 16, 2022
Est. completion date December 30, 2022

Study information

Verified date February 2022
Source Ankara Training and Research Hospital
Contact Ali Kaan Yildiz
Phone +90 554 773 16 96
Email alikaanyildiz@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date December 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Homemade beer consumption and not consumption Exclusion Criteria - Bleeding disorders

Study Design


Intervention

Dietary Supplement:
Homemade beer
The data of patients who consume and do not consume homemade beer will be cross-sectionally evaluated and compared.

Locations

Country Name City State
Turkey Ankara Training and Research Hospital Ankara Altindag

Sponsors (1)

Lead Sponsor Collaborator
Ankara Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rates of urinary tract symptoms Rates of urinary tract symptoms who consumed the homemade beer 3 months
Primary Rates of bladder cancer Rates of bladder cancer who consumed the homemade beer 3 months
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