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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal
    • Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Beer with 5.20 % alcohol; 330 ml beer (5.20 % alcohol)/day	Dietary supplement: Beer with 5.20 % alcohol; 330 ml beer (5.20 % alcohol)/day during 4 weeks
EXPERIMENTAL: Non-alcoholic beer with 0.45 % alcohol; 330 ml non-alcoholic beer (0.45 % alcohol)/day	Dietary supplement: Non-alcoholic beer with 0.45 % alcohol; 330 ml non-alcoholic beer (0.45 % alcohol)/day during 4 weeks
EXPERIMENTAL: Non-alcoholic beer with 0.00 % alcohol; 330 ml non-alcoholic beer (0.00 % alcohol)/day	Dietary supplement: Non-alcoholic beer with 0.00 % alcohol; 330 ml nonalcoholic beer (0.00 % alcohol)/day during 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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 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)
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)

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: Universidade Nova de Lisboa

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 26, 2018
• Primary Completion (ACTUAL): October 15, 2018
• Study Completion (ACTUAL): May 15, 2019

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (ACTUAL): May 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Alcohol; Gut microbiota; Beer
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: MICROAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No