Metabolic Side Effects of Drugs and Substances Clinical Trial
Official title:
Metabolic Imprints of Alcoholic Beverages
Metabolic imprints of five different types of alcohol will be investigated in two study
groups.
The study will be an assessor-blinded, parallel dietary trial (crossover design).
The project aims to identify the chemical nature and kinetics of metabolite changes related
to alcohol, hops, grapes and other beverage constituents as well as the brewing processes.
Metabolic imprints of five different types of alcohol will be investigated in two study
groups of 15 participants in each with equal distribution of gender, occasional (0-2 u/week)
and habitual drinkers (>2 u/week), respectively.
The intervention is divided into two periods: abstaining and drinking period. Occasional
drinkers begin the abstaining intervention and habitual drinkers begin the drinking
intervention, and cross-over after 3 weeks.
In the drinking period women consume 1 unit/day and men 2 units/day.
Study participants will consume five different types of alcohol; beer, cider, white wine, red
wine and spirits. The sequence of alcohol consumption in the drinking period is randomized by
'random number allocation'.
Study participants are asked to collect 24h urine samples three days in beginning of each
intervention and one day in the end of last intervention. The remaining days of the trial
they are asked to make a urine spot test each morning at home. Beside urine samples, they are
to give blood samples on each trial day and at screening (6 times). Overnight-fasting blood
samples are drawn at day 0, 1 and 21, 22 and 42 of the six week intervention and one at
screening before intervention.
Furthermore, participants receive kits to provide a dry blood sampling the following three
days after trial days in situ. There will also be taken blood pressure and questionnaire
handouts. A voluntary hair sample will be taken at Baseline (day 0) and final day of
intervention (day 42).
From these samples the following will be determined:
1. dehydroepiandrosterone sulphate (DHEAS) and related (steroid) hormones and metabolites
(primary hypothesis is a sustained increase in DHEAS following alcohol intake)
2. cresol, cresol sulphate, indoxyl sulphate and indole acetic acid (human microbial
co-metabolites)
3. humulone-derived conjugates and several analogues and unidentified metabolites from the
intake of raw materials from beverage production, including hops, malt, cider apples and
grapes etc. (by explorative methods)
4. malt- or brewing-related unidentified metabolites (by explorative methods)
5. additional markers of wine and strong liquor intake (by explorative methods)
6. investigating the use of sampling urine and blood on filter papers and the feasibility
of collecting small hair samples
7. investigating metabolic markers in relation to blood pressure, heart rate, physical
activity, blood lipids, fibrinogen, adiponectin, and psychosocial well-being etc. after
3 weeks light to moderate alcohol intake or abstaining.
8. metabolic profiling of urine, blood and hair to explore contrasts between periods of
drinking and abstaining or periods with specific alcoholic beverages.
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