Alcohol Consumption, Insulin Resistance
Conditions
Keywords
Metabolomics, Beer, Biomarker, Glucose response, Insulin response
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.
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.
Interventions
OTHERBeverage sequence ABCD
Participants receive test beverages in the randomised order ABCD
OTHERBeverage sequence CADB
Participants receive test beverages in the randomised order CADB
OTHERBeverage sequence DACB
Participants receive test beverages in the randomised order DACB
OTHERBeverage sequence CBAD
Participants receive test beverages in the randomised order CBAD
OTHERBeverage sequence ABDC
Participants receive test beverages in the randomised order ABDC
OTHERBeverage sequence DABC
Participants receive test beverages in the randomised order DABC
OTHERBeverage sequence DCAB
Participants receive test beverages in the randomised order DCAB
OTHERBeverage sequence DBCA
Participants receive test beverages in the randomised order BDCA
OTHERBeverage sequence ADCB
Participants receive test beverages in the randomised order ADCB
OTHERBeverage sequence BADC
Participants receive test beverages in the randomised order BADC
OTHERBeverage sequence ACDB
Participants receive test beverages in the randomised order ACDB
Sponsors
Carlsberg Breweries A/S
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve (AUC) for glucose | 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
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of fatty acid ethyl esters (FAEE) | Change from 0-180min | Change in FAEE from baseline to 180min by LC-MS/MS analysis of plasma. |
| Blood level of ethanol | 180 min | The amount of ethanol is measured via a breath test using an alcoholmeter. |
| Plasma beer metabolites (metabolic profiling with NMR and mass spectrometry). | After the intervention | Explorative marker to identify new beer intake-related metabolites in plasma. |
| Urinary content of paraaminobenzoic acid (PABA) | 24hour pooled urine from each volunteer | Total PABA metabolites by colorimetric assay to account for completeness of urine collection. |
| Urinary content of ethyl glucuronide (EtG) and ethyl sulphate (EtS) | 0-24 hours | EtG and EtS by quantitative LC-MS/MS |
| Area under the curve for insulin | 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. |
| Urinary content of acetaldehyde (ethanal) | 0 -24 hrs | Ethanal is measured by a kit and compared between treatments. |
| Urinary compounds of beer metabolites | 0-24 hrs | Metabolic profiling of urine by NMR and mass spectrometry. |
| Blood pressure | baseline and at time -30min on the last day of intervention. | Measurement of supine systolic and diastolic blood pressure |
| Body fat mass and body fat percentage | baseline | Measurement of body fat mass and fat percentage by bioimpedance |
| Urinary creatinine | 0-24hrs | Creatinine is measured by standard clinical chemistry. |
| Blood content of ethyl glucuronide (EtG) and ethyl sulphate (EtS) | 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. |
Countries
Denmark
Outcome results
None listed