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

NCT ID: NCT03513432

Last Updated: 2019-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-26

Study Completion Date

2019-05-15

Brief Summary

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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

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Beer with 5.20 % alcohol

330 ml beer (5.20 % alcohol)/day

Group Type EXPERIMENTAL

Beer with 5.20 % alcohol

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

Non-alcoholic beer with 0.45 % alcohol

Intervention Type DIETARY_SUPPLEMENT

330 ml non-alcoholic beer (0.45 % alcohol)/day during 4 weeks

Non-alcoholic beer with 0.00 % alcohol

330 ml non-alcoholic beer (0.00 % alcohol)/day

Group Type EXPERIMENTAL

Non-alcoholic beer with 0.00 % alcohol

Intervention Type DIETARY_SUPPLEMENT

330 ml nonalcoholic beer (0.00 % alcohol)/day during 4 weeks

Interventions

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Beer with 5.20 % alcohol

330 ml beer (5.20 % alcohol)/day during 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Non-alcoholic beer with 0.45 % alcohol

330 ml non-alcoholic beer (0.45 % alcohol)/day during 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Non-alcoholic beer with 0.00 % alcohol

330 ml nonalcoholic beer (0.00 % alcohol)/day during 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Nova de Lisboa

OTHER

Sponsor Role collaborator

Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Conceição Calhau, PhD

Role: PRINCIPAL_INVESTIGATOR

NOVA Medical School

Locations

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Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

Lisbon, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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MICROAL

Identifier Type: -

Identifier Source: org_study_id

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