Influence of Beer on Gut Microbiota and Biochemical Outcomes: Alcohol Impact.

Study Overview
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Brief Summary
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Our aim is to assess the effects of moderate consumption of beer and non-alcoholic beer on gut microbiota and biochemical biomarkers in healthy adults.

Official Title
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Influence of Beer on Gut Microbiota and Biochemical Outcomes: Alcohol Impact.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Beer with 5.20 % alcohol
* Dietary Supplement: Non-alcoholic beer with 0.45 % alcohol
* Dietary Supplement: Non-alcoholic beer with 0.00 % alcohol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men (18-65 years); Healthy volunteers free of chronic diseases with relevant effect on gastrointestinal system; Without a diagnosis of any digestive disease including functional bowel disorders such as IBS; Moderate alcohol consumers; Willing and able to provide written informed consent. Exclusion Criteria: Documented cardiovascular disease (ischaemic heart disease - angina or recent or old myocardial infarction or previous or cerebral vascular accident, peripheral vascular disease); With diabetes or other relevant metabolic diseases; With any known infectious diseases, namely infections with HIV, Hepatitis B or C virus; Intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks; Subjects with history of drug, alcohol or other substances abuse.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a three-arm parallel-group, randomized controlled study to evaluate the effect of consumption of beer with or without alcohol (5.20 %, 0.45 % and 0.00 %), during 4 weeks, on healthy individuals. The study will focus on the effects of beer on microbiota and biochemical biomarkers in healthy human volunteers.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beer with 5.20 % alcohol<br>330 ml beer (5.20 % alcohol)/day | Dietary Supplement: Beer with 5.20 % alcohol<br>* 330 ml beer (5.20 % alcohol)/day during 4 weeks<br>|
| Experimental: Non-alcoholic beer with 0.45 % alcohol<br>330 ml non-alcoholic beer (0.45 % alcohol)/day | Dietary Supplement: Non-alcoholic beer with 0.45 % alcohol<br>* 330 ml non-alcoholic beer (0.45 % alcohol)/day during 4 weeks<br>|
| Experimental: Non-alcoholic beer with 0.00 % alcohol<br>330 ml non-alcoholic beer (0.00 % alcohol)/day | Dietary Supplement: Non-alcoholic beer with 0.00 % alcohol<br>* 330 ml nonalcoholic beer (0.00 % alcohol)/day during 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in intestinal microbiota from baseline |  | at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fasting serum total cholesterol from baseline |  | at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) | 
| Changes in fasting serum triglycerides from baseline |  | at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) | 
| Changes in fasting serum cHDL from baseline |  | at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) | 
| Changes in fasting serum cLDL from baseline |  | at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) | 
| Changes in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) from baseline |  | at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) | 
| Changes in body mass index from baseline | Weight and height will be combined to report BMI in kg/m^2. | at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) | 
| Changes in total body fat mass from baseline |  | at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) | 
| Changes in fasting serum LPS levels from baseline |  | at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Beer, Gut microbiota, Alcohol, Cardiovascular disease