Clinical trial NCT03513432: Influence of Beer on Gut Microbiota and Biochemical Outcomes: Alcohol Impact.
Official title: Influence of Beer on Gut Microbiota and Biochemical Outcomes: Alcohol Impact.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Gut microbiota
Beer
Alcohol
Cardiovascular disease
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Universidade Nova de Lisboa
First posted: 2018-05-01
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in intestinal microbiota from baseline
timeFrame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
Secondary outcomes:
measure: Changes in fasting serum total cholesterol from baseline
timeFrame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
measure: Changes in fasting serum triglycerides from baseline
timeFrame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
measure: Changes in fasting serum cHDL from baseline
timeFrame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
measure: Changes in fasting serum cLDL from baseline
timeFrame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
measure: Changes in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) from baseline
timeFrame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
measure: Changes in body mass index from baseline
timeFrame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
measure: Changes in total body fat mass from baseline
timeFrame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
measure: Changes in fasting serum LPS levels from baseline
timeFrame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Faculdade de Ciências Médicas da Universidade NOVA de Lisboa
Study officials:
affiliation: NOVA Medical School
name: Conceição Calhau, PhD
role: PRINCIPAL_INVESTIGATOR
References: