Insulin Resistance Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science
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