Role of Gut Microbiome in the Health Benefits

NCT ID: NCT05300165

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-13
• Study Completion Date: 2020-12-30

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.

Conditions

Normal Population

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Normal population

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.

Group Type: OTHER

Beer

Intervention Type: DIETARY_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

Interventions

Beer

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco J. Tinahones, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Investigacion Biomedica de Malaga

Locations

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Countries

Spain

Other Identifiers

BEEROTA18

Identifier Type: -

Identifier Source: org_study_id