Clinical trial NCT05401604: Probiotic Beer to Enhance Gut Health and Immune System Function
Official title: Probiotic Beer to Enhance Gut Health and Immune System Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Nutrition, Healthy
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 30
Sex: MALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The experimental design used in this study is a randomised, controlled, within-subject cross-over design. Each individual will undergo a 2-week intervention each of moderate beer consumption and moderate probiotic beer consumption, with a 1-week period of washout in between. The total study duration will be 5 weeks.
Primary purpose: PREVENTION

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 beer drink, together with moderate alcohol consumption, on immunity and gut microbiome has yet to be studied. The probiotic beer used in this study taps on this unexplored research area and may potentially serve as a more healthful option to consumers than normal beer in the future, given the vast popularity of this beverage and probiotics.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Changes in inflammatory cytokine profile after moderate probiotic beer consumption.
timeFrame: 5 weeks
measure: Changes in gut microbiome profile after moderate probiotic beer consumption.
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
Study officials:
affiliation: National University of Singapore
name: Mei Hui Liu
role: PRINCIPAL_INVESTIGATOR
References: