Department of Nutrition, Exercise and Sports, University of Copenhagen
Copenhagen, Frederiksberg C, 1958, Denmark
NCT Number: NCT03384147
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.
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Notify Me20 year–70 year
All sexes
Interventional
Not applicable
Copenhagen, Frederiksberg C, 1958, Denmark
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Five different types of alcohol given to participants for 4-5 days in a random sequence for 3 weeks
Participants are abstaining from all alcoholic beverages for three weeks
Time frame: 3 weeks
Changes in dehydroepiandrosterone sulphate (DHEAS) and related (steroid) hormones and metabolites
Time frame: 3 weeks
Ethyl glucuronide, ethyl sulphate, fatty acid ethyl esters, phosphatidyl ethanol and any other ethanol metabolite
Time frame: 3 weeks
Cresol, cresol sulphate, indoxyl sulphate and indole acetic acid
Time frame: 1 day
Humulone-derived conjugates and several analogues and unidentified metabolites from the intake of raw materials used in beverage production, including hops, malt, cider apples, grapes, unknown metabolites from processing, etc.
Time frame: 1 day
Investigating the use of sampling urine on cotton sticks
Time frame: 1 day
Investigating the use of sampling blood on filter papers
Time frame: 3 weeks (1 day)
Investigating the feasibility of collecting small hair samples before and after trial
Time frame: 1d - 3 weeks
Investigating changes in blood pressure and heart rate from beginning to end of each intervention period.
Time frame: 1d - 3weeks
Investigating changes in physical activity from beginning to end of each intervention period using a chip with a 3D-gyro mounted on the thigh to record movements during periods of 24-72 hours at the beginning and end of the intervention periods.
Time frame: 3 weeks
Investigating changes in blood lipids at the end of each intervention period
Time frame: 3 weeks
Investigating changes in fibrinogen and related coagulation factors at the end of each intervention period
Time frame: 3 weeks
Investigating changes in adiponectin at the end of each intervention period
Time frame: 3 weeks
Investigating changes in psycho-social well-being using a standardized questionnaire at the beginning and end of each intervention period.
Time frame: 3 weeks
Metabolic profiles of blood, urine or hair discriminating periods of alcohol drinking and abstaining determined by receiver-operator characteristics of prediction models provided by partial least squares discriminant analyses comparing random training and test sets.
Time frame: 4-5 days
Metabolic profiles of dry urine spots discriminating periods of drinking specific alcoholic beverages (beer, cider, red wine, white wine or spirits) with abstaining determined by receiver-operator characteristics of prediction models provided by partial least squares discriminant analyses comparing random training and test sets.
University of Copenhagen
Other
Acronym: MetAl
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