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Metabolic Imprints of Alcoholic Beverages

NCT ID: NCT03384147

Last Updated: 2017-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-13

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Metabolic Side Effects of Drugs and Substances

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Intake of alcoholic drinks or abstaining cannot be masked to participants or care providers (delivering the alcoholic beverages). The outcomes included biomarkers of alcohol intake so in practice the investigator and outcomes assessor could not be blinded either.

Study Groups

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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

Group Type EXPERIMENTAL

Drinking

Intervention Type DIETARY_SUPPLEMENT

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

Abstaining

Intervention Type OTHER

Participants are abstaining from all alcoholic beverages for three weeks

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)

Group Type EXPERIMENTAL

Drinking

Intervention Type DIETARY_SUPPLEMENT

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

Abstaining

Intervention Type OTHER

Participants are abstaining from all alcoholic beverages for three weeks

Interventions

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Drinking

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

Intervention Type DIETARY_SUPPLEMENT

Abstaining

Participants are abstaining from all alcoholic beverages for three weeks

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Carlsberg Foundation

UNKNOWN

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Professor Lars Ove Dragsted

Professor, Head of Section

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars O Dragsted, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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Department of Nutrition, Exercise and Sports, University of Copenhagen

Copenhagen, Frederiksberg C, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 36501072 (View on PubMed)

Other Identifiers

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M228

Identifier Type: -

Identifier Source: org_study_id