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

NCT03513432 | Completed

• 1 other identifier: MICROAL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Gut microbiota; Beer; Alcohol; Cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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)

Study Arms (3)

Beer with 5.20 % alcohol

EXPERIMENTAL

330 ml beer (5.20 % alcohol)/day

Dietary Supplement: Beer with 5.20 % alcohol

Non-alcoholic beer with 0.45 % alcohol

EXPERIMENTAL

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

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

Dietary Supplement: Non-alcoholic beer with 0.00 % alcohol

Interventions

Beer with 5.20 % alcohol DIETARY_SUPPLEMENT

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

Beer with 5.20 % alcohol

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 0.45 % alcohol

Non-alcoholic beer with 0.00 % alcohol DIETARY_SUPPLEMENT

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

Non-alcoholic beer with 0.00 % alcohol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead
• Universidade Nova de Lisboa: collaborator

Study Sites (1)

Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

Lisbon, Portugal

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Beer; Ethanol

Intervention Hierarchy (Ancestors)

Alcoholic Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Beverages; Fermented Foods; Food and Beverages; Alcohols; Organic Chemicals

Study Officials

• Conceição Calhau, PhD

  NOVA Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: May 1, 2018
• Study Start: March 26, 2018
• Primary Completion: October 15, 2018
• Study Completion: May 15, 2019
• Last Updated: May 28, 2019

Record last verified: 2019-05

Locations

PT (1)