Metabolic Imprints of Alcoholic Beverages (MetAl)

December 22, 2017 updated by: Professor Lars Ove Dragsted, University of Copenhagen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Frederiksberg C
      • Copenhagen, Frederiksberg C, Denmark, 1958
        • Department of Nutrition, Exercise and sports, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Drinking

Occasional drinkers assigned to start with a 3week drinking period (women 1 u/day - men 2 u/day)

Followed by crossover without washout to 3 week abstaining period
Dietary supplement: Drinking
Five different types of alcohol given to participants for 4-5 days in a random sequence for 3 weeks
Other: Abstaining
Participants are abstaining from all alcoholic beverages for three weeks
EXPERIMENTAL: Abstaining

Habitual drinkers assigned to start 2 weeks of abstaining from alcohol

Followed by crossover without washout to 3 weeks drinking (women 1 u/day - men 2 u/day)
Dietary supplement: Drinking
Five different types of alcohol given to participants for 4-5 days in a random sequence for 3 weeks
Other: Abstaining
Participants are abstaining from all alcoholic beverages for three weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
DHEAS
Time Frame: 3 weeks
Changes in dehydroepiandrosterone sulphate (DHEAS) and related (steroid) hormones and metabolites
3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Markers of alcohol intake
Time Frame: 3 weeks
Ethyl glucuronide, ethyl sulphate, fatty acid ethyl esters, phosphatidyl ethanol and any other ethanol metabolite
3 weeks
Human microbial co-metabolites
Time Frame: 3 weeks
Cresol, cresol sulphate, indoxyl sulphate and indole acetic acid
3 weeks
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.
1 day
Metabolites from outcomes 1-4 measured in dry urine spots
Time Frame: 1 day
Investigating the use of sampling urine on cotton sticks
1 day
Metabolites from outcomes 1-4 measured in dry blood samples
Time Frame: 1 day
Investigating the use of sampling blood on filter papers
1 day
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
3 weeks (1 day)
Blood pressure
Time Frame: 1d - 3 weeks
Investigating changes in blood pressure and heart rate from beginning to end of each intervention period.
1d - 3 weeks
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.
1d - 3weeks
Blood lipids
Time Frame: 3 weeks
Investigating changes in blood lipids at the end of each intervention period
3 weeks
Fibrinogen
Time Frame: 3 weeks
Investigating changes in fibrinogen and related coagulation factors at the end of each intervention period
3 weeks
Adiponectin
Time Frame: 3 weeks
Investigating changes in adiponectin at the end of each intervention period
3 weeks
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.
3 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3 weeks
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.
4-5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Copenhagen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Carlsberg Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After study completion the participant ID's will be anonymized to allow data sharing

IPD Sharing Time Frame

3-6 months after publication of data in a peer reviewed journal when the study has been fully anonymized.

IPD Sharing Access Criteria

Through the web-site, https://enpadasi.science.ku.dk/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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