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

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: 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

• 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

Study Timeline

• Study Start: 2018-03-26
• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-30
• Study First Posted: 2018-05-01
• Primary Completion: 2018-10-15
• Status Verified: 2019-05
• Study Completion: 2019-05-15
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

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

Arm && Interventions

Group	Intervention	Description
Beer with 5.20 % alcohol	Beer with 5.20 % alcohol	330 ml beer (5.20 % alcohol)/day
Non-alcoholic beer with 0.45 % alcohol	Non-alcoholic beer with 0.45 % alcohol	330 ml non-alcoholic beer (0.45 % alcohol)/day
Non-alcoholic beer with 0.00 % alcohol	Non-alcoholic beer with 0.00 % alcohol	330 ml non-alcoholic beer (0.00 % alcohol)/day

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)

Trial Locations

Locations (1)

Faculdade de Ciências Médicas da Universidade NOVA de Lisboa; 🇵🇹 Lisboa, Portugal