BEEROTA18: Role of Gut Microbiome in the Health Benefits

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT05300165

Collaborator

(none)

Enrollment

Location

Arm

22.5

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Normal Population	Dietary Supplement: Beer	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Role of Gut Microbiome in the Health Benefits

Actual Study Start Date :

Feb 13, 2019

Actual Primary Completion Date :

Jun 19, 2019

Actual Study Completion Date :

Dec 30, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Changes in gut microbiota [Baseline, 2nd, 4th and 6th weeks visits]
change from baseline in 16S rRNA amplicons determined in DNA from feces after 6 weeks

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Virgen de la Victoria	Málaga		Spain	29010

Sponsors and Collaborators

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 (IBIMA).

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT05300165

Other Study ID Numbers:

BEEROTA18

First Posted:

Mar 29, 2022

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

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

beer

Study Results

No Results Posted as of Mar 29, 2022