Metabolic Imprints of Alcoholic Beverages
Condition: Metabolic Side Effects of Drugs and Substances
MeSH terms: Drug-Related Side Effects and Adverse Reactions; Metabolic Side Effects of Drugs and Substances
Study type: Interventional

Summary: 
      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.
    

Detailed 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:

        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.
    

Intervention name(s): Drinking; Abstaining
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: The study was conducted in two predefined groups of volunteers, 1) daily alcohol users of maximally one (females) or two (males) drinks per day, and 2) occasional drinkers (0-2 drinks per week). Group 1 was asked to abstain from alcohol for 3 weeks, then to resume drinking 1-2 drinks daily for the next three weeks. Group 2 was asked to drink 1-2 drinks daily for 3 weeks and then to abstain for the following 3 weeks. During the alcohol intake period both groups were randomized to sequences of 4-5 days with red wine, white wine, lager beer, apple cider, or spirits. The primary endpoint was an effect of alcohol on dihydroepiandrosterone sulphate excretion in urine. Biomarkers of alcohol intake and alcohol-induced metabolic change, physical activity, or well-being were secondary outcomes.
Masking: None (Open Label)
Primary purpose: Basic Science