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| Name | Class |
|---|---|
| Carlsberg Breweries A/S | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beverage sequence ABCD | Experimental | 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) |
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| Beverage sequence CADB | Experimental | 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) |
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| Beverage sequence DACB | Experimental | 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beverage sequence ABCD | Other | Participants receive test beverages in the randomised order ABCD |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-180 min |
| Plasma concentration of fatty acid ethyl esters (FAEE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars O. Dragsted, Professor | Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 30, 1958 Frederiksberg C, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition, Exercise and Sports, University of Copenhagen | Frederiksberg C | 1958 | Denmark |
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| Beverage sequence CBAD | Experimental | 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) |
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| Beverage sequence ABDC | Experimental | 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) |
|
| Beverage sequence DABC | Experimental | 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) |
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| Beverage sequence DCAB | Experimental | 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) |
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| Beverage sequence DBCA | Experimental | 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) |
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| Beverage sequence ADCB | Experimental | 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) |
|
| Beverage sequence BADC | Experimental | 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) |
|
| Beverage sequence ACDB | Experimental | 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) |
|
| Beverage sequence CADB | Other | Participants receive test beverages in the randomised order CADB |
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| Beverage sequence DACB | Other | Participants receive test beverages in the randomised order DACB |
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| Beverage sequence CBAD | Other | Participants receive test beverages in the randomised order CBAD |
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| Beverage sequence ABDC | Other | Participants receive test beverages in the randomised order ABDC |
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| Beverage sequence DABC | Other | Participants receive test beverages in the randomised order DABC |
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| Beverage sequence DCAB | Other | Participants receive test beverages in the randomised order DCAB |
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| Beverage sequence DBCA | Other | Participants receive test beverages in the randomised order BDCA |
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| Beverage sequence ADCB | Other | Participants receive test beverages in the randomised order ADCB |
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| Beverage sequence BADC | Other | Participants receive test beverages in the randomised order BADC |
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| Beverage sequence ACDB | Other | Participants receive test beverages in the randomised order ACDB |
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Change in FAEE from baseline to 180min by LC-MS/MS analysis of plasma.
| Change from 0-180min |
| Blood level of ethanol | The amount of ethanol is measured via a breath test using an alcoholmeter. | 180 min |
| Plasma beer metabolites (metabolic profiling with NMR and mass spectrometry). | Explorative marker to identify new beer intake-related metabolites in plasma. | After the intervention |
| Urinary content of paraaminobenzoic acid (PABA) | Total PABA metabolites by colorimetric assay to account for completeness of urine collection. | 24hour pooled urine from each volunteer |
| Urinary content of ethyl glucuronide (EtG) and ethyl sulphate (EtS) | EtG and EtS by quantitative LC-MS/MS | 0-24 hours |
| 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. | 0-180 min |
| Urinary content of acetaldehyde (ethanal) | Ethanal is measured by a kit and compared between treatments. | 0 -24 hrs |
| Urinary compounds of beer metabolites | Metabolic profiling of urine by NMR and mass spectrometry. | 0-24 hrs |
| Blood pressure | Measurement of supine systolic and diastolic blood pressure | baseline and at time -30min on the last day of intervention. |
| Body fat mass and body fat percentage | Measurement of body fat mass and fat percentage by bioimpedance | baseline |
| Urinary creatinine | Creatinine is measured by standard clinical chemistry. | 0-24hrs |
| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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