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Trial record 33 of 1007 for:    Area Under Curve AND insulin

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

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ClinicalTrials.gov Identifier: NCT02449577
Recruitment Status : Completed
First Posted : May 20, 2015
Last Update Posted : May 20, 2015
Sponsor:
Collaborator:
Carlsberg Breweries A/S
Information provided by (Responsible Party):
Professor Lars Ove Dragsted, University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Alcohol Consumption Insulin Resistance Other: Beverage sequence ABCD Other: Beverage sequence CADB Other: Beverage sequence DACB Other: Beverage sequence CBAD Other: Beverage sequence ABDC Other: Beverage sequence DABC Other: Beverage sequence DCAB Other: Beverage sequence DBCA Other: Beverage sequence ADCB Other: Beverage sequence BADC Other: Beverage sequence ACDB Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
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 Start Date : May 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Beverage sequence ABCD
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)
Other: Beverage sequence ABCD
Participants receive test beverages in the randomised order ABCD

Experimental: Beverage sequence CADB
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)
Other: Beverage sequence CADB
Participants receive test beverages in the randomised order CADB

Experimental: Beverage sequence DACB
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)
Other: Beverage sequence DACB
Participants receive test beverages in the randomised order DACB

Experimental: Beverage sequence CBAD
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)
Other: Beverage sequence CBAD
Participants receive test beverages in the randomised order CBAD

Experimental: Beverage sequence ABDC
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)
Other: Beverage sequence ABDC
Participants receive test beverages in the randomised order ABDC

Experimental: Beverage sequence DABC
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)
Other: Beverage sequence DABC
Participants receive test beverages in the randomised order DABC

Experimental: Beverage sequence DCAB
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)
Other: Beverage sequence DCAB
Participants receive test beverages in the randomised order DCAB

Experimental: Beverage sequence DBCA
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)
Other: Beverage sequence DBCA
Participants receive test beverages in the randomised order BDCA

Experimental: Beverage sequence ADCB
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)
Other: Beverage sequence ADCB
Participants receive test beverages in the randomised order ADCB

Experimental: Beverage sequence BADC
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)
Other: Beverage sequence BADC
Participants receive test beverages in the randomised order BADC

Experimental: Beverage sequence ACDB
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)
Other: Beverage sequence ACDB
Participants receive test beverages in the randomised order ACDB




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449577


Locations
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Denmark
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Carlsberg Breweries A/S
Investigators
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Principal Investigator: Lars O. Dragsted, Professor Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 30, 1958 Frederiksberg C, Denmark

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Responsible Party: Professor Lars Ove Dragsted, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02449577     History of Changes
Other Study ID Numbers: M212
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015

Keywords provided by Professor Lars Ove Dragsted, University of Copenhagen:
Metabolomics
Beer
Biomarker
Glucose response
Insulin response

Additional relevant MeSH terms:
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Insulin Resistance
Insulin
Alcohol Drinking
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Drinking Behavior
Ethanol
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants