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Identification of Biomarkers for Acute Intake of Beer and Alcohol and Acute Effects on Plasma and Insulin Response (METABEER)

Primary Purpose

Alcohol Consumption, Insulin Resistance

Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Beverage sequence ABCD
Beverage sequence CADB
Beverage sequence DACB
Beverage sequence CBAD
Beverage sequence ABDC
Beverage sequence DABC
Beverage sequence DCAB
Beverage sequence DBCA
Beverage sequence ADCB
Beverage sequence BADC
Beverage sequence ACDB
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Consumption focused on measuring Metabolomics, Beer, Biomarker, Glucose response, Insulin response

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy man or woman in the age group 18-60 years
  • Likes and tolerates pasta, tomatoes and cheese, and is not a vegetarian or vegan, since meat (beef and pork) is included in the standardized dinner, breakfast and in the test meal
  • Habitual alcohol intake (high: up to 7/14 units per week for women/men) or low: 0-2 units per week for both genders
  • Tolerates alcohol

Exclusion Criteria:

  • Systematic infections, psychiatric conditions and metabolic disease, and any clinical condition and other condition/situation, which according to the experimenter's assessment makes the person unfit to participate in the study
  • Donation of a larger amount of blood (more than 24 ml) e.g. in connection with donation or other scientific research study, during the study and 3 months before start of the study
  • Alcohol intake above the Danish Health and Medicines Authority's recommended 7 respective 14 drinks (units) per week for women and men
  • Have or have had a drug addiction
  • Allergy or intolerance to any of the tested drinks, or to any other foods included in the study. The participant will be specifically screened for possible alcohol allergy or intolerance
  • Nursing, pregnancy or planned pregnancy.
  • Not capable of complying with the procedures stipulated in the protocol.

Sites / Locations

  • Department of Nutrition, Exercise and Sports, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Beverage sequence ABCD

Beverage sequence CADB

Beverage sequence DACB

Beverage sequence CBAD

Beverage sequence ABDC

Beverage sequence DABC

Beverage sequence DCAB

Beverage sequence DBCA

Beverage sequence ADCB

Beverage sequence BADC

Beverage sequence ACDB

Arm Description

Each participant randomized to this arm is exposed to 4 test meals in the order ABCD with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Each participant randomized to this arm is exposed to 4 test meals in the order CADB with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Each participant randomized to this arm is exposed to 4 test meals in the order DACB with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Each participant randomized to this arm is exposed to 4 test meals in the order CBAD with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Each participant randomized to this arm is exposed to 4 test meals in the order ABDC with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Each participant randomized to this arm is exposed to 4 test meals in the order DABC with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Each participant randomized to this arm is exposed to 4 test meals in the order DCAB with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Each participant randomized to this arm is exposed to 4 test meals in the order DBCA with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Each participant randomized to this arm is exposed to 4 test meals in the order ADCB with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Each participant randomized to this arm is exposed to 4 test meals in the order BADC with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Each participant randomized to this arm is exposed to 4 test meals in the order ACDB with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)

Outcomes

Primary Outcome Measures

Area under the curve (AUC) for glucose
Glucose is measured at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.

Secondary Outcome Measures

Area under the curve for insulin
Insulin is measured at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.
Plasma concentration of fatty acid ethyl esters (FAEE)
Change in FAEE from baseline to 180min by LC-MS/MS analysis of plasma.
Blood level of ethanol
The amount of ethanol is measured via a breath test using an alcoholmeter.
Plasma beer metabolites (metabolic profiling with NMR and mass spectrometry).
Explorative marker to identify new beer intake-related metabolites in plasma.
Urinary content of paraaminobenzoic acid (PABA)
Total PABA metabolites by colorimetric assay to account for completeness of urine collection.
Urinary content of ethyl glucuronide (EtG) and ethyl sulphate (EtS)
EtG and EtS by quantitative LC-MS/MS
Blood content of ethyl glucuronide (EtG) and ethyl sulphate (EtS)
EtG and EtS are measured at 0, 45, 90, 120 and 180 minutes and the difference between treatments is determined by multivariate ANOVA followed (if significantly different) by t-tests for each time point.
Urinary content of acetaldehyde (ethanal)
Ethanal is measured by a kit and compared between treatments.
Urinary compounds of beer metabolites
Metabolic profiling of urine by NMR and mass spectrometry.
Blood pressure
Measurement of supine systolic and diastolic blood pressure
Body fat mass and body fat percentage
Measurement of body fat mass and fat percentage by bioimpedance
Urinary creatinine
Creatinine is measured by standard clinical chemistry.

Full Information

First Posted
June 28, 2013
Last Updated
May 19, 2015
Sponsor
University of Copenhagen
Collaborators
Carlsberg Breweries A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02449577
Brief Title
Identification of Biomarkers for Acute Intake of Beer and Alcohol and Acute Effects on Plasma and Insulin Response
Acronym
METABEER
Official Title
Metabolomics in Beer Research: Identification of Biomarkers for Acute Intake of Beer and Alcohol in Individuals With a High or Low Habitual Intake, and Acute Effects on Plasma Glucose and Insulin Response Compared to Regular Soda
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Carlsberg Breweries A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of the study is to identify biomarkers for acute intake of beer and alcohol in individuals with a high or low habitual intake. Furthermore, we wish to identify compounds and metabolites in different types of beer and alcohol, which can serve as compliance markers for intake under the test conditions (blood tests and urine samples). We also wish to determine the acute effects of these beverages on plasma glucose and insulin response, compared to regular soda.
Detailed Description
The study is designed as a randomized, 4-way single-blinded cross-over intervention study. The participants are randomized individually to the order by which they shall receive 4 test meals. There will be implemented a standardized lunch which includes respectively 1) Light/alcohol-free (Tuborg Super Light 0,1% alcohol), 2) Regular lager (4,6% alcohol), 3) Strong beer(7,2% alcohol) and 4) a control drink without alcohol but with the same energy content (carbohydrate and protein) as the average of the other beverages ("sportsdrink"). Besides 330 ml of each test drink, each test meal consists of grilled cheese sandwiches (Tulip Food Company) and the amount of toast adjusted according to the type of drink served with each meal, so the content of macronutrients is the same in each meal. The study includes 16-20 participants, randomized as to which order they will receive the 4 test meals with a washout period of at least 6 days in between test days. Upon arrival the test persons are asked to urinate (baseline sample), and at the 1st visit they are then weighed, height is measured and body composition (bioimpedance) is measured. After resting briefly, a baseline blood sample is taken and blood pressure is measured (1st and 4th visit). 45 minutes after start of the test meal the first postprandial blood sample is taken, and again after 45, 120 and 180 minutes. Urine is collected again at 0-90 min, 90-180 min and 3-24 hours after the test meal. Participants are provided with containers and equipment for this purpose, and must submit samples on an ongoing basis to the Dept. of Nutrition, Exercise and Sports.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption, Insulin Resistance
Keywords
Metabolomics, Beer, Biomarker, Glucose response, Insulin response

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beverage sequence ABCD
Arm Type
Experimental
Arm Description
Each participant randomized to this arm is exposed to 4 test meals in the order ABCD with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)
Arm Title
Beverage sequence CADB
Arm Type
Experimental
Arm Description
Each participant randomized to this arm is exposed to 4 test meals in the order CADB with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)
Arm Title
Beverage sequence DACB
Arm Type
Experimental
Arm Description
Each participant randomized to this arm is exposed to 4 test meals in the order DACB with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)
Arm Title
Beverage sequence CBAD
Arm Type
Experimental
Arm Description
Each participant randomized to this arm is exposed to 4 test meals in the order CBAD with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)
Arm Title
Beverage sequence ABDC
Arm Type
Experimental
Arm Description
Each participant randomized to this arm is exposed to 4 test meals in the order ABDC with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)
Arm Title
Beverage sequence DABC
Arm Type
Experimental
Arm Description
Each participant randomized to this arm is exposed to 4 test meals in the order DABC with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)
Arm Title
Beverage sequence DCAB
Arm Type
Experimental
Arm Description
Each participant randomized to this arm is exposed to 4 test meals in the order DCAB with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)
Arm Title
Beverage sequence DBCA
Arm Type
Experimental
Arm Description
Each participant randomized to this arm is exposed to 4 test meals in the order DBCA with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)
Arm Title
Beverage sequence ADCB
Arm Type
Experimental
Arm Description
Each participant randomized to this arm is exposed to 4 test meals in the order ADCB with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)
Arm Title
Beverage sequence BADC
Arm Type
Experimental
Arm Description
Each participant randomized to this arm is exposed to 4 test meals in the order BADC with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)
Arm Title
Beverage sequence ACDB
Arm Type
Experimental
Arm Description
Each participant randomized to this arm is exposed to 4 test meals in the order ACDB with a washout period of at least a week between each meal. Each meal consisted of a standardized lunch of Parisian toast (sandwichbread, ham, cheese) together with a beverage. Each beverage is assigned a letter, A, B, C, or D. The letter assignment is blinded. The following four drinks were used Placebo: 330 ml of a soft drink (Sports drink), Beer 1 - 330 ml of an alcohol-free beer (<0.1% alcohol), Beer 2 - 330 ml of a regular lager beer (4.6% alcohol), and Beer 3 - 330 ml of a strong beer (7.2% alcohol)
Intervention Type
Other
Intervention Name(s)
Beverage sequence ABCD
Intervention Description
Participants receive test beverages in the randomised order ABCD
Intervention Type
Other
Intervention Name(s)
Beverage sequence CADB
Intervention Description
Participants receive test beverages in the randomised order CADB
Intervention Type
Other
Intervention Name(s)
Beverage sequence DACB
Intervention Description
Participants receive test beverages in the randomised order DACB
Intervention Type
Other
Intervention Name(s)
Beverage sequence CBAD
Intervention Description
Participants receive test beverages in the randomised order CBAD
Intervention Type
Other
Intervention Name(s)
Beverage sequence ABDC
Intervention Description
Participants receive test beverages in the randomised order ABDC
Intervention Type
Other
Intervention Name(s)
Beverage sequence DABC
Intervention Description
Participants receive test beverages in the randomised order DABC
Intervention Type
Other
Intervention Name(s)
Beverage sequence DCAB
Intervention Description
Participants receive test beverages in the randomised order DCAB
Intervention Type
Other
Intervention Name(s)
Beverage sequence DBCA
Intervention Description
Participants receive test beverages in the randomised order BDCA
Intervention Type
Other
Intervention Name(s)
Beverage sequence ADCB
Intervention Description
Participants receive test beverages in the randomised order ADCB
Intervention Type
Other
Intervention Name(s)
Beverage sequence BADC
Intervention Description
Participants receive test beverages in the randomised order BADC
Intervention Type
Other
Intervention Name(s)
Beverage sequence ACDB
Intervention Description
Participants receive test beverages in the randomised order ACDB
Primary Outcome Measure Information:
Title
Area under the curve (AUC) for glucose
Description
Glucose is measured at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.
Time Frame
0-180 minutes
Secondary Outcome Measure Information:
Title
Area under the curve for insulin
Description
Insulin is measured at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.
Time Frame
0-180 min
Title
Plasma concentration of fatty acid ethyl esters (FAEE)
Description
Change in FAEE from baseline to 180min by LC-MS/MS analysis of plasma.
Time Frame
Change from 0-180min
Title
Blood level of ethanol
Description
The amount of ethanol is measured via a breath test using an alcoholmeter.
Time Frame
180 min
Title
Plasma beer metabolites (metabolic profiling with NMR and mass spectrometry).
Description
Explorative marker to identify new beer intake-related metabolites in plasma.
Time Frame
After the intervention
Title
Urinary content of paraaminobenzoic acid (PABA)
Description
Total PABA metabolites by colorimetric assay to account for completeness of urine collection.
Time Frame
24hour pooled urine from each volunteer
Title
Urinary content of ethyl glucuronide (EtG) and ethyl sulphate (EtS)
Description
EtG and EtS by quantitative LC-MS/MS
Time Frame
0-24 hours
Title
Blood content of ethyl glucuronide (EtG) and ethyl sulphate (EtS)
Description
EtG and EtS are measured at 0, 45, 90, 120 and 180 minutes and the difference between treatments is determined by multivariate ANOVA followed (if significantly different) by t-tests for each time point.
Time Frame
0-180 min
Title
Urinary content of acetaldehyde (ethanal)
Description
Ethanal is measured by a kit and compared between treatments.
Time Frame
0 -24 hrs
Title
Urinary compounds of beer metabolites
Description
Metabolic profiling of urine by NMR and mass spectrometry.
Time Frame
0-24 hrs
Title
Blood pressure
Description
Measurement of supine systolic and diastolic blood pressure
Time Frame
baseline and at time -30min on the last day of intervention.
Title
Body fat mass and body fat percentage
Description
Measurement of body fat mass and fat percentage by bioimpedance
Time Frame
baseline
Title
Urinary creatinine
Description
Creatinine is measured by standard clinical chemistry.
Time Frame
0-24hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy man or woman in the age group 18-60 years Likes and tolerates pasta, tomatoes and cheese, and is not a vegetarian or vegan, since meat (beef and pork) is included in the standardized dinner, breakfast and in the test meal Habitual alcohol intake (high: up to 7/14 units per week for women/men) or low: 0-2 units per week for both genders Tolerates alcohol Exclusion Criteria: Systematic infections, psychiatric conditions and metabolic disease, and any clinical condition and other condition/situation, which according to the experimenter's assessment makes the person unfit to participate in the study Donation of a larger amount of blood (more than 24 ml) e.g. in connection with donation or other scientific research study, during the study and 3 months before start of the study Alcohol intake above the Danish Health and Medicines Authority's recommended 7 respective 14 drinks (units) per week for women and men Have or have had a drug addiction Allergy or intolerance to any of the tested drinks, or to any other foods included in the study. The participant will be specifically screened for possible alcohol allergy or intolerance Nursing, pregnancy or planned pregnancy. Not capable of complying with the procedures stipulated in the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars O. Dragsted, Professor
Organizational Affiliation
Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 30, 1958 Frederiksberg C, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition, Exercise and Sports, University of Copenhagen
City
Frederiksberg C
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Identification of Biomarkers for Acute Intake of Beer and Alcohol and Acute Effects on Plasma and Insulin Response

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