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

• Sponsor: Universidade do Porto (Other)
• Overall Status: Completed
• CT.gov ID: NCT03513432
• Collaborator: Universidade Nova de Lisboa (Other)
• Enrollment: 30
• Location: 1
• Arms: 3
• Actual Duration (Months): 13.6
• Patients Per Site Per Month: 2.2

Study Details

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	N/A

Study Design

• Study Type: Interventional
• 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.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: Mar 26, 2018
• Actual Primary Completion Date: Oct 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 [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 [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 [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 [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 [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 [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 [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 [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 [at visit 1 (after 1-week run-in period) and at visit 2 (after 4-week intake period)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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

Study Results

No Results Posted as of May 28, 2019