Metabolic Imprints of Alcoholic Beverages (MetAl)
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About
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.
Full description
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:
- dehydroepiandrosterone sulphate (DHEAS) and related (steroid) hormones and metabolites (primary hypothesis is a sustained increase in DHEAS following alcohol intake)
- cresol, cresol sulphate, indoxyl sulphate and indole acetic acid (human microbial co-metabolites)
- 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)
- malt- or brewing-related unidentified metabolites (by explorative methods)
- additional markers of wine and strong liquor intake (by explorative methods)
- investigating the use of sampling urine and blood on filter papers and the feasibility of collecting small hair samples
- 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.
- metabolic profiling of urine, blood and hair to explore contrasts between periods of drinking and abstaining or periods with specific alcoholic beverages.
Enrollment
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Volunteers
Inclusion criteria
- 20 years of age
- No intolerance of alcohol
- Experience with alcohol
- Able to use smartphone or tablet
Exclusion criteria
- Serious chronic health conditions or psychiatric diseases
- Chronic intake of medicine (beside birth control and SSRI)
- Alcohol and/or drug abuse assessed AUDIT score >4 (AUDIT = Alcohol Use Disorders Identification Test).
- Blood samples/donations during trial and 3 months prior
- Liver dysfunction
- High risk of breast cancer assessed by BCRAT score (BCRAT = The Breast Cancer Risk Assessment Tool)
- Pregnancy or lactating
Trial design
Primary purpose
Allocation
Interventional model
Masking
26 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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