Metabolic Imprints of Alcoholic Beverages

Metabolic Side Effects of Drugs and Substances Clinical Trial

— MetAl  

Official title:

Metabolic Imprints of Alcoholic Beverages

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384147
• Other study ID #: M228
• Status: Completed
• Phase: N/A
• First received: December 11, 2017
• Last updated: December 22, 2017
• Start date: January 13, 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 constituents as well as the brewing processes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Metabolic Side Effects of Drugs and Substances

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports, University of Copenhagen	Copenhagen	Frederiksberg C

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Carlsberg Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Discriminant metabolic profiles	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
Other	Discriminant metabolic profiles	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
Primary	DHEAS	Changes in dehydroepiandrosterone sulphate (DHEAS) and related (steroid) hormones and metabolites	3 weeks
Secondary	Markers of alcohol intake	Ethyl glucuronide, ethyl sulphate, fatty acid ethyl esters, phosphatidyl ethanol and any other ethanol metabolite	3 weeks
Secondary	Human microbial co-metabolites	Cresol, cresol sulphate, indoxyl sulphate and indole acetic acid	3 weeks
Secondary	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.	1 day
Secondary	Metabolites from outcomes 1-4 measured in dry urine spots	Investigating the use of sampling urine on cotton sticks	1 day
Secondary	Metabolites from outcomes 1-4 measured in dry blood samples	Investigating the use of sampling blood on filter papers	1 day
Secondary	Metabolites from outcomes 1-4 measured in a hair sample	Investigating the feasibility of collecting small hair samples before and after trial	3 weeks (1 day)
Secondary	Blood pressure	Investigating changes in blood pressure and heart rate from beginning to end of each intervention period.	1d - 3 weeks
Secondary	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.	1d - 3weeks
Secondary	Blood lipids	Investigating changes in blood lipids at the end of each intervention period	3 weeks
Secondary	Fibrinogen	Investigating changes in fibrinogen and related coagulation factors at the end of each intervention period	3 weeks
Secondary	Adiponectin	Investigating changes in adiponectin at the end of each intervention period	3 weeks
Secondary	Psychosocial well-being	Investigating changes in psycho-social well-being using a standardized questionnaire at the beginning and end of each intervention period.	3 weeks