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Completed

NCT Number: NCT02449577

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg C, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Beverage sequence ABCD

Other

Participants receive test beverages in the randomised order ABCD

Beverage sequence CADB

Other

Participants receive test beverages in the randomised order CADB

Beverage sequence DACB

Other

Participants receive test beverages in the randomised order DACB

Beverage sequence CBAD

Other

Participants receive test beverages in the randomised order CBAD

Beverage sequence ABDC

Other

Participants receive test beverages in the randomised order ABDC

Beverage sequence DABC

Other

Participants receive test beverages in the randomised order DABC

Beverage sequence DCAB

Other

Participants receive test beverages in the randomised order DCAB

Beverage sequence DBCA

Other

Participants receive test beverages in the randomised order BDCA

Beverage sequence ADCB

Other

Participants receive test beverages in the randomised order ADCB

Beverage sequence BADC

Other

Participants receive test beverages in the randomised order BADC

Beverage sequence ACDB

Other

Participants receive test beverages in the randomised order ACDB

Primary outcomes

  1. Area under the curve (AUC) for glucose

    Time frame: 0-180 minutes

    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 outcomes

  1. Area under the curve for insulin

    Time frame: 0-180 min

    Insulin is measured at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.

  2. Plasma concentration of fatty acid ethyl esters (FAEE)

    Time frame: Change from 0-180min

    Change in FAEE from baseline to 180min by LC-MS/MS analysis of plasma.

  3. Blood level of ethanol

    Time frame: 180 min

    The amount of ethanol is measured via a breath test using an alcoholmeter.

  4. Plasma beer metabolites (metabolic profiling with NMR and mass spectrometry).

    Time frame: After the intervention

    Explorative marker to identify new beer intake-related metabolites in plasma.

  5. Urinary content of paraaminobenzoic acid (PABA)

    Time frame: 24hour pooled urine from each volunteer

    Total PABA metabolites by colorimetric assay to account for completeness of urine collection.

  6. Urinary content of ethyl glucuronide (EtG) and ethyl sulphate (EtS)

    Time frame: 0-24 hours

    EtG and EtS by quantitative LC-MS/MS

  7. Blood content of ethyl glucuronide (EtG) and ethyl sulphate (EtS)

    Time frame: 0-180 min

    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.

  8. Urinary content of acetaldehyde (ethanal)

    Time frame: 0 -24 hrs

    Ethanal is measured by a kit and compared between treatments.

  9. Urinary compounds of beer metabolites

    Time frame: 0-24 hrs

    Metabolic profiling of urine by NMR and mass spectrometry.

  10. Blood pressure

    Time frame: baseline and at time -30min on the last day of intervention.

    Measurement of supine systolic and diastolic blood pressure

  11. Body fat mass and body fat percentage

    Time frame: baseline

    Measurement of body fat mass and fat percentage by bioimpedance

  12. Urinary creatinine

    Time frame: 0-24hrs

    Creatinine is measured by standard clinical chemistry.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Carlsberg Breweries A/S

Registry information

Official study 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

Acronym: METABEER

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 20, 2015
Registry last updated
May 20, 2015

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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