Status:
COMPLETED
Probiotic Beer to Enhance Gut Health and Immune System Function
Lead Sponsor:
National University of Singapore
Conditions:
Inflammation
Nutrition, Healthy
Eligibility:
MALE
21-60 years
Phase:
NA
Brief Summary
This study investigates the immunological and gut microbiome effects of moderate probiotic beer consumption.
Detailed Description
Studies have shown that moderate alcohol consumption and probiotics have each shown immunomodulatory anti-inflammatory effects. However, to our knowledge, the effect of adding a probiotic strain to a ...
Eligibility Criteria
Inclusion
- Ability to give informed consent.
- 21 - 60 years of age (inclusive) at screening.
- Healthy male, as determined by medical history, physical examination and laboratory results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
- Race must be Chinese.
- Willing to consume 1 beer can per day for 14 days.
- Not on any regular medications (western/ traditional).
- No family history of alcoholism.
Exclusion
- Female.
- A current smoker, have smoked, or is a user of tobacco products for the past 2 years.
- History or presence of current lipid and cardiovascular disorders, respiratory, hepatic, renal, gastrointestinal, endocrine, lipid disorder, haematological, malignancy or neurological disorders capable of significantly altering the performance of the biomarker panel; or of interfering with the interpretation of data.
- History of alcoholism, alcohol dependence, alcohol abuse, alcohol allergy and/or any other alcohol use disorders.
- History of Type 1/ Type 2 diabetes and use of anti-diabetic medications in the past.
- Regular use of medication that are known to have an effect on immune function.
- Regular use of aspirin.
- A naïve alcohol drinker.
- Persons with known or ongoing psychiatric disorders or drug abuse within 3 years.
- Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to first visit of the study.
- Treatment with any investigational drug, or biological agent within one (1) month of screening or plans to enter into an investigational drug/ biological agent study during the duration of this study.
- Significant change in weight (+/- 5%) during the past month.
- Antibiotic use in the past 2 months.
Key Trial Info
Start Date :
August 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05401604
Start Date
August 27 2021
End Date
February 18 2022
Last Update
June 2 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National University of Singapore
Singapore, Singapore, 118177