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Completed

NCT Number: NCT05401604

Probiotic Beer to Enhance Gut Health and Immune System Function

This study investigates the immunological and gut microbiome effects of moderate probiotic beer consumption.

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Key information

Age range

21 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

National University of Singapore

Singapore, 118177

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moderate probiotic beer consumption

Dietary Supplement

Consumption of one can of probiotic beer per day for 14 days. Blood and fecal samples will be collected at the start and end of the intervention to analyse for immunological biomarkers and gut microbiome.

Moderate normal beer consumption

Dietary Supplement

Consumption of one can of normal beer per day for 14 days. Blood and fecal samples will be collected at the start and end of the intervention to analyse for immunological biomarkers and gut microbiome.

Primary outcomes

  1. Changes in inflammatory cytokine profile after moderate probiotic beer consumption.

    Time frame: 5 weeks

    Changes in inflammatory cytokine profile (IFNg, TNFa, IL-1b, IL-2, IL-4, IL-6, IL-10, IL-12) in blood samples of individuals after moderate probiotic beer consumption, in comparison to moderate normal beer consumption.

  2. Changes in gut microbiome profile after moderate probiotic beer consumption.

    Time frame: 5 weeks

    Changes in gut microbiome profile from DNA sequencing in stool samples after moderate probiotic beer consumption, in comparison to moderate normal beer consumption.

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Acronym: PBEER

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 2, 2022
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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