Identification of Biomarkers for Acute Intake of Beer and Alcohol and Acute Effects on Plasma and Insulin Response

Insulin Resistance Clinical Trial

— METABEER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449577
• Other study ID #: M212
• 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

• Alcohol Consumption
• Alcohol Drinking
• Insulin Resistance

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