Probiotic Beer to Enhance Gut Health and Immune System Function

NCT ID: NCT05401604

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-27
• Study Completion Date: 2022-02-18

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.

Conditions

Inflammation; Nutrition, Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Moderate probiotic beer consumption

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).

Group Type: EXPERIMENTAL

Moderate probiotic beer consumption

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Moderate normal beer consumption

Intervention Type: 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.

Interventions

Moderate probiotic beer consumption

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.

Intervention Type: DIETARY_SUPPLEMENT

Moderate normal beer consumption

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National University of Singapore

OTHER

Sponsor Role: lead

Responsible Party

Mei Hui Liu

Co-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mei Hui Liu

Role: PRINCIPAL_INVESTIGATOR

National University of Singapore

Locations

National University of Singapore

Singapore, , Singapore

Countries

Singapore

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2021/00196

Identifier Type: -

Identifier Source: org_study_id