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OpenTrials
Completed

NCT Number: NCT03513432

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.

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Key information

Conditions

Healthy Volunteers Cardiovascular Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

Lisbon, Portugal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Beer with 5.20 % alcohol

Dietary Supplement

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

Non-alcoholic beer with 0.45 % alcohol

Dietary Supplement

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

Non-alcoholic beer with 0.00 % alcohol

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Collaborators

  • Universidade Nova de Lisboa

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 1, 2018
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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