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

• ClinicalTrials.gov Identifier: NCT03513432
• Recruitment Status: Completed
• First Posted: May 1, 2018
• Last Update Posted: May 28, 2019
• Sponsor: Universidade do Porto
• Collaborator: Universidade Nova de Lisboa
• Information provided by (Responsible Party): Universidade do Porto

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

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.

• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Influence of Beer on Gut Microbiota and Biochemical Outcomes: Alcohol Impact.
• Actual Study Start Date: March 26, 2018
• Actual Primary Completion Date: October 15, 2018
• Actual Study Completion Date: May 15, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Changes in intestinal microbiota from baseline [ Time Frame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) ]

Secondary Outcome Measures :

1. Changes in fasting serum total cholesterol from baseline [ Time Frame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) ]
2. Changes in fasting serum triglycerides from baseline [ Time Frame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) ]
3. Changes in fasting serum cHDL from baseline [ Time Frame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) ]
4. Changes in fasting serum cLDL from baseline [ Time Frame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) ]
5. Changes in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) from baseline [ Time Frame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) ]
6. Changes in body mass index from baseline [ Time Frame: 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.
7. Changes in total body fat mass from baseline [ Time Frame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) ]
8. Changes in fasting serum LPS levels from baseline [ Time Frame: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Portugal

Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

Lisboa, Portugal

Sponsors and Collaborators

Universidade do Porto

Universidade Nova de Lisboa

Investigators

• Principal Investigator: Conceição Calhau, PhD; NOVA Medical School

More Information

• Responsible Party: Universidade do Porto
• ClinicalTrials.gov Identifier: NCT03513432
• Other Study ID Numbers: MICROAL
• First Posted: May 1, 2018
• Last Update Posted: May 28, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universidade do Porto:

Gut microbiota; Beer; Alcohol; Cardiovascular disease

Additional relevant MeSH terms:

Ethanol; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Physiological Effects of Drugs