Skip to content

Role of Gut Microbiome in the Health Benefits

Role of Gut Microbiome in the Health Benefits

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05300165
Acronym
BEEROTA18
Enrollment
20
Registered
2022-03-29
Start date
2019-02-13
Completion date
2020-12-30
Last updated
2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Population

Keywords

beer

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTBeer

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

Sponsors

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Age \> 18 years * Usual consumer of Beer

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in gut microbiotaBaseline, 2nd, 4th and 6th weeks visitschange from baseline in 16S rRNA amplicons determined in DNA from feces after 6 weeks

Secondary

MeasureTime frameDescription
Change in waist circumferenceBaseline and 6th weeks visitsChange from baseline in waist circumference (cm) after the completion of the trial
Change in glucose concentrationBaseline and 6th weeks visitsChange from baseline in serum glucose level after the completion of the trial
Change in caloric consumptionBaseline and 6th weeks visitschange from baseline in the number of caloric consumption measured by an structured nutrient intake
Change in triglycerides concentrationBaseline and 6th weeks visitsChange from baseline in serum triglycerides level after the completion of the trial
Change in blood pressureBaseline and 6th weeks visitsChange from baseline in blood pressure (systolic and diastolic) after the completion of the trial
Change in HDL-cholesterol concentrationBaseline and 6th weeks visitsChange from baseline in serum HDL-cholesterol level after the completion of the trial

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026