Role of Gut Microbiome in the Health Benefits (BEEROTA18)

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 Overview

• Status: Completed
• Conditions: Normal Population
• Intervention / Treatment: Dietary supplement: Beer

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in caloric consumption	change from baseline in the number of caloric consumption measured by an structured nutrient intake	Baseline and 6th weeks visits
Change in waist circumference	Change from baseline in waist circumference (cm) after the completion of the trial	Baseline and 6th weeks visits
Change in glucose concentration	Change from baseline in serum glucose level after the completion of the trial	Baseline and 6th weeks visits
Change in HDL-cholesterol concentration	Change from baseline in serum HDL-cholesterol level after the completion of the trial	Baseline and 6th weeks visits
Change in triglycerides concentration	Change from baseline in serum triglycerides level after the completion of the trial	Baseline and 6th weeks visits
Change in blood pressure	Change from baseline in blood pressure (systolic and diastolic) after the completion of the trial	Baseline and 6th weeks visits

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Investigators: Principal Investigator: Francisco J. Tinahones, PhD, Instituto de Investigación Biomédica de Málaga

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Actual): June 19, 2019
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: beer
• Other Study ID Numbers: BEEROTA18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No