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Completed

NCT Number: NCT03384147

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports, University of Copenhagen

Copenhagen, Frederiksberg C, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drinking

Dietary Supplement

Five different types of alcohol given to participants for 4-5 days in a random sequence for 3 weeks

Abstaining

Other

Participants are abstaining from all alcoholic beverages for three weeks

Primary outcomes

  1. DHEAS

    Time frame: 3 weeks

    Changes in dehydroepiandrosterone sulphate (DHEAS) and related (steroid) hormones and metabolites

Secondary outcomes

  1. Markers of alcohol intake

    Time frame: 3 weeks

    Ethyl glucuronide, ethyl sulphate, fatty acid ethyl esters, phosphatidyl ethanol and any other ethanol metabolite

  2. Human microbial co-metabolites

    Time frame: 3 weeks

    Cresol, cresol sulphate, indoxyl sulphate and indole acetic acid

  3. Markers of intake of raw materials from the beverage productions

    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.

  4. Metabolites from outcomes 1-4 measured in dry urine spots

    Time frame: 1 day

    Investigating the use of sampling urine on cotton sticks

  5. Metabolites from outcomes 1-4 measured in dry blood samples

    Time frame: 1 day

    Investigating the use of sampling blood on filter papers

  6. Metabolites from outcomes 1-4 measured in a hair sample

    Time frame: 3 weeks (1 day)

    Investigating the feasibility of collecting small hair samples before and after trial

  7. Blood pressure

    Time frame: 1d - 3 weeks

    Investigating changes in blood pressure and heart rate from beginning to end of each intervention period.

  8. Physical activity monitoring

    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.

  9. Blood lipids

    Time frame: 3 weeks

    Investigating changes in blood lipids at the end of each intervention period

  10. Fibrinogen

    Time frame: 3 weeks

    Investigating changes in fibrinogen and related coagulation factors at the end of each intervention period

  11. Adiponectin

    Time frame: 3 weeks

    Investigating changes in adiponectin at the end of each intervention period

  12. Psychosocial well-being

    Time frame: 3 weeks

    Investigating changes in psycho-social well-being using a standardized questionnaire at the beginning and end of each intervention period.

Other outcomes

  1. Discriminant metabolic profiles

    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.

  2. Discriminant metabolic profiles

    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.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Carlsberg Foundation

Registry information

Acronym: MetAl

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Dec 27, 2017
Registry last updated
Dec 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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