Normal PopulationBEEROTA18NCT05300165
Role of Gut Microbiome in the Health Benefits
A study testing Beer in people with Normal Population, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial summary
Beneficial effects of moderate chronic consumption of beer have been extensively reported, however, the mechanisms have not been elucidated yet. Gut microbiota is an important mediator in the homeostasis of the host. Polyphenols act as bacterial substrates and modulators of the gut microbiota. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Population
- What is being tested?
- Beer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 13 Feb 2019to 30 Dec 2020
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Usual consumer of Beer
Who cannot join
- being a non usual beer-consumer,
- body mass index (BMI) > 40 kg m2.
- acute or chronic infection, inflammatory disease or endocrine disorders; history of cancer; leukocytosis; anti-inflammatory, corticosteroid or hormone treatment.
- history of alcohol abuse or drug dependence.
- under a restrictive diet or a weight change ≥5 kg during the 3 months prior to the study.
- antibiotic therapy, prebiotics, probiotics, synbiotics, vitamin supplements or any other medical treatment influencing intestinal microbiota during the 3 months before the start of the study or during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Beneficial effects of moderate chronic consumption of beer have been extensively reported, however, the mechanisms have not been elucidated yet. Gut microbiota is an important mediator in the homeostasis of the host. Polyphenols act as bacterial substrates and modulators of the gut microbiota. Indeed, the investigators have previously observed that the chronic moderate consumption of red wine by metabolic syndrome patients triggered in an amelioration of the metabolic syndrome variables, and this effect was mediated, at least partially, by the interaction of the gut microbiota with the polyphenols of the red wine. In this manner, beer has a medium content of polyphenols. Thus, the investigators propose that the beneficial effects of moderate chronic consumption of beer could be because of the action of the gut microbiota with the beer polyphenols. The investigators are going to perform an intervention study in which normal volunteers will consume three different beer types with different content in polyphenols and it will be analyzed the gut microbiota profile (Metagenomics), metabolites (Metabolomics) and metabolic syndrome markers (gene expression, ELISA) to establish the correspondent relationships, trying to decipher the implication of the gut microbiota in the beneficial effects of moderate chronic consumption of beer.
- Conditions
- Normal Population
- Being tested
- Beer
- Keywords
- beer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeerDietary supplement
A daily beer will be consumed by the participants during a total of 6 weeks, changing every 2 weeks from alcohol-free lager beer, lager beer and dark beer
| Study group | Role | What they receive |
|---|---|---|
| Normal population | Other | 20 participants representing a normal population will include a daily beer in their meals, changing the kind of beer every 2 weeks from alcohol-free lager beer, lager beer, or dark beer. Receives: Dietary Supplement: Beer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbiota
change from baseline in 16S rRNA amplicons determined in DNA from feces after 6 weeks
Measured: Baseline, 2nd, 4th and 6th weeks visits
Secondary outcomes (6)
Change in caloric consumption
change from baseline in the number of caloric consumption measured by an structured nutrient intake
Measured: Baseline and 6th weeks visits
Change in waist circumference
Change from baseline in waist circumference (cm) after the completion of the trial
Measured: Baseline and 6th weeks visits
Change in glucose concentration
Change from baseline in serum glucose level after the completion of the trial
Measured: Baseline and 6th weeks visits
Change in HDL-cholesterol concentration
Change from baseline in serum HDL-cholesterol level after the completion of the trial
Measured: Baseline and 6th weeks visits
Change in triglycerides concentration
Change from baseline in serum triglycerides level after the completion of the trial
Measured: Baseline and 6th weeks visits
Change in blood pressure
Change from baseline in blood pressure (systolic and diastolic) after the completion of the trial
Measured: Baseline and 6th weeks visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start13 Feb 2019
- Primary completion19 Jun 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal PopulationStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco J. Tinahones, PhD, Principal investigator, Instituto de Investigacion Biomedica de Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300165
- Sponsor's protocol ID
- BEEROTA18
- Acronym
- BEEROTA18
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Gut Microbiome in the Health Benefits
- ClinicalTrials.gov ID
- NCT05300165
- Acronym / sponsor ID
- BEEROTA18 / BEEROTA18
- Conditions
- Normal Population
- Keywords
- beer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 29 Mar 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.
Beneficial effects of moderate chronic consumption of beer have been extensively reported, however, the mechanisms have not been elucidated yet. Gut microbiota is an important mediator in the homeostasis of the host. Polyphenols act as bacterial substrates and modulators of the gut microbiota. Indeed, the investigators have previously observed that the chronic moderate consumption of red wine by metabolic syndrome patients triggered in an amelioration of the metabolic syndrome variables, and this effect was mediated, at least partially, by the interaction of the gut microbiota with the polyphenols of the red wine. In this manner, beer has a medium content of polyphenols. Thus, the investigators propose that the beneficial effects of moderate chronic consumption of beer could be because of the action of the gut microbiota with the beer polyphenols. The investigators are going to perform an intervention study in which normal volunteers will consume three different beer types with different content in polyphenols and it will be analyzed the gut microbiota profile (Metagenomics), metabolites (Metabolomics) and metabolic syndrome markers (gene expression, ELISA) to establish the correspondent relationships, trying to decipher the implication of the gut microbiota in the beneficial effects of moderate chronic consumption of beer.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal population | Other | Dietary Supplement: Beer20 participants representing a normal population will include a daily beer in their meals, changing the kind of beer every 2 weeks from alcohol-free lager beer, lager beer, or dark beer. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Usual consumer of Beer
Key exclusion criteria (6 listed)
- being a non usual beer-consumer,
- body mass index (BMI) > 40 kg m2.
- acute or chronic infection, inflammatory disease or endocrine disorders; history of cancer; leukocytosis; anti-inflammatory, corticosteroid or hormone treatment.
- history of alcohol abuse or drug dependence.
- under a restrictive diet or a weight change ≥5 kg during the 3 months prior to the study.
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 |
|---|---|---|
| BeerA daily beer will be consumed by the participants during a total of 6 weeks, changing every 2 weeks from alcohol-free lager beer, lager beer and dark beer | Dietary supplement | Normal population |
Primary outcome
Changes in gut microbiota
Time frame: Baseline, 2nd, 4th and 6th weeks visits
change from baseline in 16S rRNA amplicons determined in DNA from feces after 6 weeks
6 secondary outcomes
Change in caloric consumption
Time frame: Baseline and 6th weeks visits
Change in waist circumference
Time frame: Baseline and 6th weeks visits
Change in glucose concentration
Time frame: Baseline and 6th weeks visits
Change in HDL-cholesterol concentration
Time frame: Baseline and 6th weeks visits
Change in triglycerides concentration
Time frame: Baseline and 6th weeks visits
Change in blood pressure
Time frame: Baseline and 6th weeks visits
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 29 Mar 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.
Francisco J. Tinahones, PhD principal investigator
Instituto de Investigacion Biomedica de Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beer in people with Normal Population, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
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 2 inclusion and 6 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 29 Mar 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 Spain. 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. 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 gut microbiota (time frame: Baseline, 2nd, 4th and 6th weeks visits). 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 29 Mar 2022.