InflammationPBEERNCT05401604
Probiotic Beer to Enhance Gut Health and Immune System Function
A study testing Moderate probiotic beer consumption and Moderate normal beer consumption in people with Inflammation and Nutrition, Healthy, run by National University of Singapore at 1 site in Singapore.
Trial summary
This study investigates the immunological and gut microbiome effects of moderate probiotic beer consumption. Read more about this study
- Who is it for?
- Ages 21 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Nutrition, Healthy
- What is being tested?
- Moderate probiotic beer consumption and Moderate normal beer consumption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 27 Aug 2021to 18 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
This study investigates the immunological and gut microbiome effects of moderate probiotic beer consumption.
Read the 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
- Being tested
- Moderate probiotic beer consumption, Moderate normal beer consumption
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate probiotic beer consumptionDietary 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 consumptionDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Moderate probiotic beer consumption | Experimental | 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). Receives: Dietary Supplement: Moderate probiotic beer consumption |
| Moderate normal beer consumption | Placebo comparator | 1 can of 330ml (3.5-5% alcohol) normal beer. Ingredients: water, grains, raspberry puree, and yeast. Receives: Dietary Supplement: Moderate normal beer consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start27 Aug 2021
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Hui Liu, National University of Singapore
- Investigators
- Mei Hui Liu, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401604
- Sponsor's protocol ID
- 2021/00196
- Acronym
- PBEER
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Beer to Enhance Gut Health and Immune System Function
- ClinicalTrials.gov ID
- NCT05401604
- Acronym / sponsor ID
- PBEER / 2021/00196
- Conditions
- Inflammation, Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Moderate probiotic beer consumption | Experimental | Dietary Supplement: Moderate probiotic beer consumption1 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). |
| Moderate normal beer consumption | Placebo comparator | Dietary Supplement: Moderate normal beer consumption1 can of 330ml (3.5-5% alcohol) normal beer. Ingredients: water, grains, raspberry puree, and yeast. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate probiotic beer consumptionConsumption 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. | Dietary supplement | Moderate probiotic beer consumption |
| Moderate normal beer consumptionConsumption 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. | Dietary supplement | Moderate normal beer consumption |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei Hui Liu principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate probiotic beer consumption and Moderate normal beer consumption in people with Inflammation and Nutrition, Healthy, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in inflammatory cytokine profile after moderate probiotic beer consumption. (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.