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Role of Gut Microbiome in the Health Benefits (BEEROTA18)

F

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

Status

Completed

Conditions

Normal Population

Treatments

Dietary Supplement: Beer

Study type

Interventional

Funder types

Other

Identifiers

NCT05300165
BEEROTA18

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Normal population
Other group
Description:
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.
Treatment:
Dietary Supplement: Beer

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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