PBEER: Probiotic Beer to Enhance Gut Health and Immune System Function

Sponsor

National University, Singapore (Other)

Overall Status

Completed

CT.gov ID

NCT05401604

Collaborator

(none)

Enrollment

Location

Arms

5.7

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Inflammation Nutrition, Healthy	Dietary Supplement: Moderate probiotic beer consumption Dietary Supplement: Moderate normal beer consumption	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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:

Single (Participant)

Masking Description:

Participants are blinded as to which beer (i.e. normal or probiotic) they are receiving for each intervention arm.

Primary Purpose:

Prevention

Official Title:

Probiotic Beer to Enhance Gut Health and Immune System Function

Actual Study Start Date :

Aug 27, 2021

Actual Primary Completion Date :

Feb 18, 2022

Actual Study Completion Date :

Feb 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Dietary Supplement: 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.
Placebo Comparator: Moderate normal beer consumption 1 can of 330ml (3.5-5% alcohol) normal beer. Ingredients: water, grains, raspberry puree, and yeast.	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.

Arm

Intervention/Treatment

Experimental: 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).

Dietary Supplement: 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.

Placebo Comparator: Moderate normal beer consumption

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

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.

Outcome Measures

Primary Outcome Measures

Changes in inflammatory cytokine profile after moderate probiotic beer consumption. [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.
Changes in gut microbiome profile after moderate probiotic beer consumption. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National University of Singapore	Singapore		Singapore	118177

Sponsors and Collaborators

National University, Singapore

Investigators

Principal Investigator: Mei Hui Liu, National University, Singapore

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Jul 28, 2021

More Information

Publications

None provided.

Responsible Party:

Mei Hui Liu, Co-Investigator, National University, Singapore

ClinicalTrials.gov Identifier:

NCT05401604

Other Study ID Numbers:

2021/00196

First Posted:

Jun 2, 2022

Last Update Posted:

Jun 2, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Inflammation

Study Results

No Results Posted as of Jun 2, 2022