NCT02449577

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alcohol Consumption
• Insulin Resistance

Interventions

Type	Name	Description
OTHER	Beverage sequence ABCD	Participants receive test beverages in the randomised order ABCD
OTHER	Beverage sequence CADB	Participants receive test beverages in the randomised order CADB
OTHER	Beverage sequence DACB	Participants receive test beverages in the randomised order DACB
OTHER	Beverage sequence CBAD	Participants receive test beverages in the randomised order CBAD
OTHER	Beverage sequence ABDC	Participants receive test beverages in the randomised order ABDC
OTHER	Beverage sequence DABC	Participants receive test beverages in the randomised order DABC
OTHER	Beverage sequence DCAB	Participants receive test beverages in the randomised order DCAB
OTHER	Beverage sequence DBCA	Participants receive test beverages in the randomised order BDCA
OTHER	Beverage sequence ADCB	Participants receive test beverages in the randomised order ADCB
OTHER	Beverage sequence BADC	Participants receive test beverages in the randomised order BADC
OTHER	Beverage sequence ACDB	Participants receive test beverages in the randomised order ACDB

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2015-05-20
• Last updated: 2015-05-20

Locations

1 site across 1 country: Denmark