Probiotic Beer to Enhance Gut Health and Immune System Function (PBEER)

National University of Singapore

Status: Completed

Conditions: Inflammation; Nutrition, Healthy

Treatments: Dietary Supplement: Moderate normal beer consumption; Dietary Supplement: Moderate probiotic beer consumption

Study type: Interventional

Funder types: Other

Identifiers

NCT05401604

2021/00196

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: Male

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Moderate probiotic beer consumption

Experimental group

Description:

1 can of 330ml (3.5-5% alcohol) probiotic beer. Ingredients: water, grains, raspberry puree, yeast, and lactic acid bacteria (Lactobacillus paracasei Lpc-37®, or Lactobacillus paracasei LAFTI®L26).

Treatment:

Dietary Supplement: Moderate probiotic beer consumption

Moderate normal beer consumption

Placebo Comparator group

Description:

1 can of 330ml (3.5-5% alcohol) normal beer. Ingredients: water, grains, raspberry puree, and yeast.

Treatment:

Dietary Supplement: Moderate normal beer consumption