Healthy VolunteersNCT03513432
Influence of Beer on Gut Microbiota and Biochemical Outcomes: Alcohol Impact.
A study testing Beer with 5.20 % alcohol, Non-alcoholic beer with 0.45 % alcohol and Non-alcoholic beer with 0.00 % alcohol in people with Healthy Volunteers, run by Universidade do Porto at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Beer with 5.20 % alcohol, Non-alcoholic beer with 0.45 % alcohol and Non-alcoholic beer with 0.00 % alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 26 Mar 2018to 15 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculdade de Ciências Médicas da Universidade NOVA de Lisboa
Lisbon
About this study
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.
- Conditions
- Healthy Volunteers
- Being tested
- Beer with 5.20 % alcohol, Non-alcoholic beer with 0.45 % alcohol, Non-alcoholic beer with 0.00 % alcohol
- Keywords
- Gut microbiota, Beer, Alcohol, Cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beer with 5.20 % alcoholDietary supplement
330 ml beer (5.20 % alcohol)/day during 4 weeks
Non-alcoholic beer with 0.45 % alcoholDietary supplement
330 ml non-alcoholic beer (0.45 % alcohol)/day during 4 weeks
Non-alcoholic beer with 0.00 % alcoholDietary supplement
330 ml nonalcoholic beer (0.00 % alcohol)/day during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Beer with 5.20 % alcohol | Experimental | 330 ml beer (5.20 % alcohol)/day Receives: Dietary Supplement: Beer with 5.20 % alcohol |
| Non-alcoholic beer with 0.45 % alcohol | Experimental | 330 ml non-alcoholic beer (0.45 % alcohol)/day Receives: Dietary Supplement: Non-alcoholic beer with 0.45 % alcohol |
| Non-alcoholic beer with 0.00 % alcohol | Experimental | 330 ml non-alcoholic beer (0.00 % alcohol)/day Receives: Dietary Supplement: Non-alcoholic beer with 0.00 % alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in intestinal microbiota from baseline
Measured: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
Secondary outcomes (8)
Changes in fasting serum total cholesterol from baseline
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start26 Mar 2018
- Primary completion15 Oct 2018
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Nova de Lisboa
- Responsible party
- Sponsor
- Investigators
- Conceição Calhau, PhD, Principal investigator, NOVA Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513432
- Sponsor's protocol ID
- MICROAL
- Status last verified
- May 2019
- First submitted
- 12 Apr 2018
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Beer on Gut Microbiota and Biochemical Outcomes: Alcohol Impact.
- ClinicalTrials.gov ID
- NCT03513432
- Acronym / sponsor ID
- MICROAL
- Conditions
- Healthy Volunteers
- Keywords
- Gut microbiota, Beer, Alcohol, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Universidade Nova de Lisboa
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Beer with 5.20 % alcohol | Experimental | Dietary Supplement: Beer with 5.20 % alcohol330 ml beer (5.20 % alcohol)/day |
| Non-alcoholic beer with 0.45 % alcohol | Experimental | Dietary Supplement: Non-alcoholic beer with 0.45 % alcohol330 ml non-alcoholic beer (0.45 % alcohol)/day |
| Non-alcoholic beer with 0.00 % alcohol | Experimental | Dietary Supplement: Non-alcoholic beer with 0.00 % alcohol330 ml non-alcoholic beer (0.00 % alcohol)/day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beer with 5.20 % alcohol330 ml beer (5.20 % alcohol)/day during 4 weeks | Dietary supplement | Beer with 5.20 % alcohol |
| Non-alcoholic beer with 0.45 % alcohol330 ml non-alcoholic beer (0.45 % alcohol)/day during 4 weeks | Dietary supplement | Non-alcoholic beer with 0.45 % alcohol |
| Non-alcoholic beer with 0.00 % alcohol330 ml nonalcoholic beer (0.00 % alcohol)/day during 4 weeks | Dietary supplement | Non-alcoholic beer with 0.00 % alcohol |
Primary outcome
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)
8 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conceição Calhau, PhD principal investigator
NOVA Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beer with 5.20 % alcohol, Non-alcoholic beer with 0.45 % alcohol and Non-alcoholic beer with 0.00 % alcohol in people with Healthy Volunteers, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.