Role of Gut Microbiome in the Health Benefits

NCT05300165 | Completed

• 1 other identifier: BEEROTA18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

beer

Outcome Measures

Primary Outcomes (1)

• Changes in gut microbiota

  change from baseline in 16S rRNA amplicons determined in DNA from feces after 6 weeks

  Baseline, 2nd, 4th and 6th weeks visits

Secondary Outcomes (6)

• Change in caloric consumption

  Baseline and 6th weeks visits

• Change in waist circumference

  Baseline and 6th weeks visits

• Change in glucose concentration

  Baseline and 6th weeks visits

• Change in HDL-cholesterol concentration

  Baseline and 6th weeks visits

• Change in triglycerides concentration

  Baseline and 6th weeks visits

Study Arms (1)

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.

Dietary Supplement: Beer

Interventions

Beer 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

Normal population

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Usual consumer of Beer

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

MeSH Terms

Interventions

Beer

Intervention Hierarchy (Ancestors)

Alcoholic Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Beverages; Fermented Foods; Food and Beverages

Study Officials

• Francisco J. Tinahones, PhD

  Instituto de Investigacion Biomedica de Malaga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 29, 2022
• Study Start: February 13, 2019
• Primary Completion: June 19, 2019
• Study Completion: December 30, 2020
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

ES (1)