Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg C, 1958, Denmark
NCT Number: NCT02449577
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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Notify Me18 year–60 year
All sexes
Interventional
Early Phase 1
Frederiksberg C, 1958, Denmark
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants receive test beverages in the randomised order ABCD
Participants receive test beverages in the randomised order CADB
Participants receive test beverages in the randomised order DACB
Participants receive test beverages in the randomised order CBAD
Participants receive test beverages in the randomised order ABDC
Participants receive test beverages in the randomised order DABC
Participants receive test beverages in the randomised order DCAB
Participants receive test beverages in the randomised order BDCA
Participants receive test beverages in the randomised order ADCB
Participants receive test beverages in the randomised order BADC
Participants receive test beverages in the randomised order ACDB
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.
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.
Time frame: Change from 0-180min
Change in FAEE from baseline to 180min by LC-MS/MS analysis of plasma.
Time frame: 180 min
The amount of ethanol is measured via a breath test using an alcoholmeter.
Time frame: After the intervention
Explorative marker to identify new beer intake-related metabolites in plasma.
Time frame: 24hour pooled urine from each volunteer
Total PABA metabolites by colorimetric assay to account for completeness of urine collection.
Time frame: 0-24 hours
EtG and EtS by quantitative LC-MS/MS
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.
Time frame: 0 -24 hrs
Ethanal is measured by a kit and compared between treatments.
Time frame: 0-24 hrs
Metabolic profiling of urine by NMR and mass spectrometry.
Time frame: baseline and at time -30min on the last day of intervention.
Measurement of supine systolic and diastolic blood pressure
Time frame: baseline
Measurement of body fat mass and fat percentage by bioimpedance
Time frame: 0-24hrs
Creatinine is measured by standard clinical chemistry.
University of Copenhagen
Other
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
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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