Identification of Biomarkers for Acute Intake of Beer and Alcohol and Acute Effects on Plasma and Insulin Response
Condition: Alcohol Consumption; Insulin Resistance
MeSH terms: Insulin Resistance; Alcohol Drinking
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): Beverage sequence ABCD; Beverage sequence CADB; Beverage sequence DACB; Beverage sequence CBAD; Beverage sequence ABDC; Beverage sequence DABC; Beverage sequence DCAB; Beverage sequence DBCA; Beverage sequence ADCB; Beverage sequence BADC; Beverage sequence ACDB
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Metabolomics; Beer; Biomarker; Glucose response; Insulin response