Role of Gut Microbiome in the Health Benefits

Study Overview
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Brief Summary
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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.

Official Title
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Role of Gut Microbiome in the Health Benefits

Conditions
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Normal Population

Intervention / Treatment
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* Dietary Supplement: Beer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Normal population<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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beer