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Completed

NCT Number: NCT05300165

Role of Gut Microbiome in the Health Benefits

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Changes in gut microbiota

    Time frame: Baseline, 2nd, 4th and 6th weeks visits

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

Secondary outcomes

  1. Change in caloric consumption

    Time frame: Baseline and 6th weeks visits

    change from baseline in the number of caloric consumption measured by an structured nutrient intake

  2. Change in waist circumference

    Time frame: Baseline and 6th weeks visits

    Change from baseline in waist circumference (cm) after the completion of the trial

  3. Change in glucose concentration

    Time frame: Baseline and 6th weeks visits

    Change from baseline in serum glucose level after the completion of the trial

  4. Change in HDL-cholesterol concentration

    Time frame: Baseline and 6th weeks visits

    Change from baseline in serum HDL-cholesterol level after the completion of the trial

  5. Change in triglycerides concentration

    Time frame: Baseline and 6th weeks visits

    Change from baseline in serum triglycerides level after the completion of the trial

  6. Change in blood pressure

    Time frame: Baseline and 6th weeks visits

    Change from baseline in blood pressure (systolic and diastolic) after the completion of the trial

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: BEEROTA18

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 29, 2022
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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