NCT05300165: BEEROTA18

Role of Gut Microbiome in the Health Benefits

Completed NA Last updated 29 March 2022

What this trial tests

NA trial testing Beer in Normal Population in 20 participants. Completed in 30 December 2020.

Timeline

13 February 2019

Primary endpoint
19 June 2019

30 December 2020

Quick facts

Lead sponsor	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	20
Start date	13 February 2019
Primary completion	19 June 2019
Estimated completion	30 December 2020
Sites	1 location across Spain

Drugs / interventions tested

• Beer — full drug profile →

Conditions studied

• Normal Population — all drugs for Normal Population →

Sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud — full company profile →

Who can join

Adults 18 to 70, any sex, with Normal Population. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Moderate Consumption of Different Phenolic-Content Beers on the Human Gut Microbiota Composition: A Randomized Crossover Trial.
   Martínez-Montoro JI, Quesada-Molina M, Gutiérrez-Repiso C, Ruiz-Limón P, et al · · 2022 · cited 12× · PMID 35453381 · DOI 10.3390/antiox11040696
2. Beer-Derived (Poly)phenol Metabolism in Individuals With and Without Metabolic Syndrome: A Comparative Dietary Intervention.
   Hinojosa-Nogueira D, Díaz-Perdigones CM, García-López MJ, Marcos A, et al · · 2025 · PMID 40733197 · DOI 10.3390/molecules30142932