Healthy Volunteers
Conditions
Keywords
Gut microbiota, Beer, Alcohol, Cardiovascular disease
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.
Interventions
DIETARY_SUPPLEMENTBeer with 5.20 % alcohol
330 ml beer (5.20 % alcohol)/day during 4 weeks
DIETARY_SUPPLEMENTNon-alcoholic beer with 0.45 % alcohol
330 ml non-alcoholic beer (0.45 % alcohol)/day during 4 weeks
DIETARY_SUPPLEMENTNon-alcoholic beer with 0.00 % alcohol
330 ml nonalcoholic beer (0.00 % alcohol)/day during 4 weeks
Sponsors
Universidade Nova de Lisboa
Universidade do Porto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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) | — |
| 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 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) | — |
Countries
Portugal
Outcome results
None listed