Role of Gut Microbiome in the Health Benefits

Normal Population Clinical Trial

— BEEROTA18  

Official title:

Role of Gut Microbiome in the Health Benefits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05300165
• Other study ID #: BEEROTA18
• Status: Completed
• Phase: N/A
• Start date: February 13, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2022
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 30, 2020
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Normal Population

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de la Victoria	Málaga

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

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