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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02449577
Other study ID # M212
Secondary ID
Status Completed
Phase Phase 0
First received June 28, 2013
Last updated May 19, 2015
Start date May 2013
Est. completion date June 2013

Study information

Verified date May 2015
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: Danish Health and Medicines Authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Beverage sequence ABCD
Participants receive test beverages in the randomised order ABCD
Beverage sequence CADB
Participants receive test beverages in the randomised order CADB
Beverage sequence DACB
Participants receive test beverages in the randomised order DACB
Beverage sequence CBAD
Participants receive test beverages in the randomised order CBAD
Beverage sequence ABDC
Participants receive test beverages in the randomised order ABDC
Beverage sequence DABC
Participants receive test beverages in the randomised order DABC
Beverage sequence DCAB
Participants receive test beverages in the randomised order DCAB
Beverage sequence DBCA
Participants receive test beverages in the randomised order BDCA
Beverage sequence ADCB
Participants receive test beverages in the randomised order ADCB
Beverage sequence BADC
Participants receive test beverages in the randomised order BADC
Beverage sequence ACDB
Participants receive test beverages in the randomised order ACDB

Locations

Country Name City State
Denmark Department of Nutrition, Exercise and Sports, University of Copenhagen Frederiksberg C

Sponsors (2)

Lead Sponsor Collaborator
University of Copenhagen Carlsberg Breweries A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary Plasma concentration of fatty acid ethyl esters (FAEE) Change in FAEE from baseline to 180min by LC-MS/MS analysis of plasma. Change from 0-180min No
Secondary Blood level of ethanol The amount of ethanol is measured via a breath test using an alcoholmeter. 180 min No
Secondary Plasma beer metabolites (metabolic profiling with NMR and mass spectrometry). Explorative marker to identify new beer intake-related metabolites in plasma. After the intervention No
Secondary 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 No
Secondary Urinary content of ethyl glucuronide (EtG) and ethyl sulphate (EtS) EtG and EtS by quantitative LC-MS/MS 0-24 hours No
Secondary 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 No
Secondary Urinary content of acetaldehyde (ethanal) Ethanal is measured by a kit and compared between treatments. 0 -24 hrs No
Secondary Urinary compounds of beer metabolites Metabolic profiling of urine by NMR and mass spectrometry. 0-24 hrs No
Secondary Blood pressure Measurement of supine systolic and diastolic blood pressure baseline and at time -30min on the last day of intervention. No
Secondary Body fat mass and body fat percentage Measurement of body fat mass and fat percentage by bioimpedance baseline No
Secondary Urinary creatinine Creatinine is measured by standard clinical chemistry. 0-24hrs No
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