Clinical trial NCT05300165: Role of Gut Microbiome in the Health Benefits
Official title: Role of Gut Microbiome in the Health Benefits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Population
Keywords: beer
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in gut microbiota
timeFrame: Baseline, 2nd, 4th and 6th weeks visits
Secondary outcomes:
measure: Change in caloric consumption
timeFrame: Baseline and 6th weeks visits
measure: Change in waist circumference
timeFrame: Baseline and 6th weeks visits
measure: Change in glucose concentration
timeFrame: Baseline and 6th weeks visits
measure: Change in HDL-cholesterol concentration
timeFrame: Baseline and 6th weeks visits
measure: Change in triglycerides concentration
timeFrame: Baseline and 6th weeks visits
measure: Change in blood pressure
timeFrame: Baseline and 6th weeks visits
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
Study officials:
affiliation: Instituto de Investigacion Biomedica de Malaga
name: Francisco J. Tinahones, PhD
role: PRINCIPAL_INVESTIGATOR
References: