Clinical trial NCT02449577: Identification of Biomarkers for Acute Intake of Beer and Alcohol and Acute Effects on Plasma and Insulin Response
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alcohol Consumption
Insulin Resistance
Keywords: Metabolomics
Beer
Biomarker
Glucose response
Insulin response
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Carlsberg Breweries A/S
First posted: 2015-05-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: Area under the curve (AUC) for glucose
timeFrame: 0-180 minutes
Secondary outcomes:
measure: Area under the curve for insulin
timeFrame: 0-180 min
measure: Plasma concentration of fatty acid ethyl esters (FAEE)
timeFrame: Change from 0-180min
measure: Blood level of ethanol
timeFrame: 180 min
measure: Plasma beer metabolites (metabolic profiling with NMR and mass spectrometry).
timeFrame: After the intervention
measure: Urinary content of paraaminobenzoic acid (PABA)
timeFrame: 24hour pooled urine from each volunteer
measure: Urinary content of ethyl glucuronide (EtG) and ethyl sulphate (EtS)
timeFrame: 0-24 hours
measure: Blood content of ethyl glucuronide (EtG) and ethyl sulphate (EtS)
timeFrame: 0-180 min
measure: Urinary content of acetaldehyde (ethanal)
timeFrame: 0 -24 hrs
measure: Urinary compounds of beer metabolites
timeFrame: 0-24 hrs
measure: Blood pressure
timeFrame: baseline and at time -30min on the last day of intervention.
measure: Body fat mass and body fat percentage
timeFrame: baseline
measure: Urinary creatinine
timeFrame: 0-24hrs
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: Department of Nutrition, Exercise and Sports, University of Copenhagen
Study officials:
affiliation: Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 30, 1958 Frederiksberg C, Denmark
name: Lars O. Dragsted, Professor
role: PRINCIPAL_INVESTIGATOR
References: