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

Primary Purpose

Inflammation, Nutrition, Healthy

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Moderate probiotic beer consumption
Moderate normal beer consumption
Sponsored by
National University of Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammation

Eligibility Criteria

21 Years - 60 Years (Adult)MaleAccepts 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.

Sites / Locations

  • National University of Singapore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Moderate probiotic beer consumption

Moderate normal beer consumption

Arm 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).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 24, 2022
Last Updated
May 27, 2022
Sponsor
National University of Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT05401604
Brief Title
Probiotic Beer to Enhance Gut Health and Immune System Function
Acronym
PBEER
Official Title
Probiotic Beer to Enhance Gut Health and Immune System Function
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
February 18, 2022 (Actual)
Study Completion Date
February 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Nutrition, Healthy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Participant
Masking Description
Participants are blinded as to which beer (i.e. normal or probiotic) they are receiving for each intervention arm.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate probiotic beer consumption
Arm Type
Experimental
Arm 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).
Arm Title
Moderate normal beer consumption
Arm Type
Placebo Comparator
Arm Description
1 can of 330ml (3.5-5% alcohol) normal beer. Ingredients: water, grains, raspberry puree, and yeast.
Intervention Type
Dietary Supplement
Intervention Name(s)
Moderate probiotic beer consumption
Intervention Description
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
Intervention Name(s)
Moderate normal beer consumption
Intervention Description
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 Outcome Measure Information:
Title
Changes in inflammatory cytokine profile after moderate probiotic beer consumption.
Description
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.
Time Frame
5 weeks
Title
Changes in gut microbiome profile after moderate probiotic beer consumption.
Description
Changes in gut microbiome profile from DNA sequencing in stool samples after moderate probiotic beer consumption, in comparison to moderate normal beer consumption.
Time Frame
5 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei Hui Liu
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University of Singapore
City
Singapore
ZIP/Postal Code
118177
Country
Singapore

12. IPD Sharing Statement

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Probiotic Beer to Enhance Gut Health and Immune System Function

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