Metabolic Side Effects of Drugs and SubstancesMetAlNCT03384147
Metabolic Imprints of Alcoholic Beverages
A study testing Drinking and Abstaining in people with Metabolic Side Effects of Drugs and Substances, run by University of Copenhagen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Side Effects of Drugs and Substances
- What is being tested?
- Drinking and Abstaining
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Jan 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 years of age
- No intolerance of alcohol
- Experience with alcohol
- Able to use smartphone or tablet
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports, University of Copenhagen
Copenhagen, Frederiksberg C, 1958
About this study
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.
Read the 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:
- 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.
- Being tested
- Drinking, Abstaining
- Medical subject headings
- Metabolic Side Effects of Drugs and Substances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrinkingDietary supplement
Five different types of alcohol given to participants for 4-5 days in a random sequence for 3 weeks
AbstainingOther
Participants are abstaining from all alcoholic beverages for three weeks
| Study group | Role | What they receive |
|---|---|---|
| Drinking | Experimental | 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 Receives: Dietary Supplement: Drinking; Other: Abstaining |
| Abstaining | Experimental | 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) Receives: Dietary Supplement: Drinking; Other: Abstaining |
What is being measured
The primary outcome is the main question the study is designed to answer.
DHEAS
Changes in dehydroepiandrosterone sulphate (DHEAS) and related (steroid) hormones and metabolites
Measured: 3 weeks
Secondary outcomes (12)
Markers of alcohol intake
Ethyl glucuronide, ethyl sulphate, fatty acid ethyl esters, phosphatidyl ethanol and any other ethanol metabolite
Measured: 3 weeks
Human microbial co-metabolites
Cresol, cresol sulphate, indoxyl sulphate and indole acetic acid
Measured: 3 weeks
Markers of intake of raw materials from the beverage productions
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.
Measured: 1 day
Metabolites from outcomes 1-4 measured in dry urine spots
Investigating the use of sampling urine on cotton sticks
Measured: 1 day
Metabolites from outcomes 1-4 measured in dry blood samples
Investigating the use of sampling blood on filter papers
Measured: 1 day
Metabolites from outcomes 1-4 measured in a hair sample
Investigating the feasibility of collecting small hair samples before and after trial
Measured: 3 weeks (1 day)
Blood pressure
Investigating changes in blood pressure and heart rate from beginning to end of each intervention period.
Measured: 1d - 3 weeks
Physical activity monitoring
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.
Measured: 1d - 3weeks
Blood lipids
Investigating changes in blood lipids at the end of each intervention period
Measured: 3 weeks
Fibrinogen
Investigating changes in fibrinogen and related coagulation factors at the end of each intervention period
Measured: 3 weeks
Adiponectin
Investigating changes in adiponectin at the end of each intervention period
Measured: 3 weeks
Psychosocial well-being
Investigating changes in psycho-social well-being using a standardized questionnaire at the beginning and end of each intervention period.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start13 Jan 2016
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Side Effects of Drugs and SubstancesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Carlsberg Foundation
- Responsible party
- Principal investigator, Professor Lars Ove Dragsted, University of Copenhagen
- Investigators
- Lars O Dragsted, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384147
- Sponsor's protocol ID
- M228
- Acronym
- MetAl
- Status last verified
- Dec 2017
- First submitted
- 11 Dec 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: After study completion the participant ID's will be anonymized to allow data sharing
Publications
Wilkens TL, Ziegler Z, Aru V, Khakimov B, Overgaard SL, Engelsen SB, Dragsted LO. 1-2 Drinks Per Day Affect Lipoprotein Composition after 3 Weeks-Results from a Cross-Over Pilot Intervention Trial in Healthy Adults Using Nuclear Magnetic Resonance-Measured Lipoproteins and Apolipoproteins. Nutrients. 2022 Nov 27;14(23):5043. doi: 10.3390/nu14235043.
PubMed 36501072
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Imprints of Alcoholic Beverages
- ClinicalTrials.gov ID
- NCT03384147
- Acronym / sponsor ID
- MetAl / M228
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Carlsberg Foundation
- Study start
- 13 Jan 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Drinking | Experimental | Dietary Supplement: Drinking, Other: AbstainingOccasional 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 |
| Abstaining | Experimental | Dietary Supplement: Drinking, Other: AbstainingHabitual 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) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 20 years of age
- No intolerance of alcohol
- Experience with alcohol
- Able to use smartphone or tablet
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DrinkingFive different types of alcohol given to participants for 4-5 days in a random sequence for 3 weeks | Dietary supplement | Abstaining, Drinking |
| AbstainingParticipants are abstaining from all alcoholic beverages for three weeks | Other | Abstaining, Drinking |
Primary outcome
DHEAS
Time frame: 3 weeks
Changes in dehydroepiandrosterone sulphate (DHEAS) and related (steroid) hormones and metabolites
12 secondary outcomes
Markers of alcohol intake
Time frame: 3 weeks
Human microbial co-metabolites
Time frame: 3 weeks
Markers of intake of raw materials from the beverage productions
Time frame: 1 day
Metabolites from outcomes 1-4 measured in dry urine spots
Time frame: 1 day
Metabolites from outcomes 1-4 measured in dry blood samples
Time frame: 1 day
Metabolites from outcomes 1-4 measured in a hair sample
Time frame: 3 weeks (1 day)
Blood pressure
Time frame: 1d - 3 weeks
Physical activity monitoring
Time frame: 1d - 3weeks
Blood lipids
Time frame: 3 weeks
Fibrinogen
Time frame: 3 weeks
Adiponectin
Time frame: 3 weeks
Psychosocial well-being
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Derived from this study: PubMed 36501072Wilkens TL, Ziegler Z, Aru V, Khakimov B, Overgaard SL, Engelsen SB, Dragsted LO. 1-2 Drinks Per Day Affect Lipoprotein Composition after 3 Weeks-Results from a Cross-Over Pilot Intervention Trial in Healthy Adults Using Nuclear Magnetic Resonance-Measured Lipoproteins and Apolipoproteins. Nutrients. 2022 Nov 27;14(23):5043. doi: 10.3390/nu14235043.
- Individual participant dataSharing planned: Yes. After study completion the participant ID's will be anonymized to allow data sharing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars O Dragsted, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drinking and Abstaining in people with Metabolic Side Effects of Drugs and Substances, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DHEAS (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03384147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2017.