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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03513432
• Other study ID #: MICROAL
• Status: Completed
• Phase: N/A
• Start date: March 26, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: May 2019
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 15, 2019
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Beer with 5.20 % alcohol
330 ml beer (5.20 % alcohol)/day during 4 weeks
• Non-alcoholic beer with 0.45 % alcohol
330 ml non-alcoholic beer (0.45 % alcohol)/day during 4 weeks
• Non-alcoholic beer with 0.00 % alcohol
330 ml nonalcoholic beer (0.00 % alcohol)/day during 4 weeks

Locations

Country	Name	City	State
Portugal	Faculdade de Ciências Médicas da Universidade NOVA de Lisboa	Lisboa

Sponsors (2)

Lead Sponsor	Collaborator
Universidade do Porto	Universidade Nova de Lisboa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)