Influence of Beer on Gut Microbiota and Biochemical Outcomes: Alcohol Impact.
Not Applicable
Completed
- Conditions
- Healthy Volunteers
- Registration Number
- NCT03513432
- Lead Sponsor
- Universidade do Porto
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 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 cLDL 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) Changes in body mass index from baseline at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) Weight and height will be combined to report BMI in kg/m\^2.
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)
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms link beer consumption to gut microbiota modulation in healthy adults?
How does non-alcoholic beer compare to standard dietary interventions in altering gut microbial diversity?
Which biochemical biomarkers are most responsive to moderate beer consumption in microbiota studies?
What adverse events are associated with beer's ethanol content in gut microbiome research?
Are there synergistic effects when combining beer with prebiotics or probiotics for microbiota health?
Trial Locations
- Locations (1)
Faculdade de Ciências Médicas da Universidade NOVA de Lisboa
🇵🇹Lisboa, Portugal
Faculdade de Ciências Médicas da Universidade NOVA de Lisboa🇵🇹Lisboa, Portugal