- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03384147
Metabolic Imprints of Alcoholic Beverages (MetAl)
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
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Frederiksberg C
-
Copenhagen, Frederiksberg C, Denmark, 1958
- Department of Nutrition, Exercise and Sports, University of Copenhagen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
---|---|
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 |
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
|
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) |
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
|
What is the study measuring?
Primary Outcome Measures
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
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M228
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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