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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
NameTimeMethod
Changes in intestinal microbiota from baselineat visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
Secondary Outcome Measures
NameTimeMethod
Changes in fasting serum triglycerides from baselineat visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
Changes in fasting serum cHDL from baselineat 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 baselineat visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
Changes in fasting serum total cholesterol from baselineat visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
Changes in fasting serum cLDL from baselineat visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
Changes in fasting serum LPS levels from baselineat visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
Changes in body mass index from baselineat 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 baselineat visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)

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

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