NCT03506516

Brief Summary

Does mixing alcohol make hangover worse?

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2016

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

10 days

First QC Date

February 12, 2018

Last Update Submit

April 23, 2018

Conditions

Alcohol-Related Disorders

Keywords

alcohol, hangover

Outcome Measures

Primary Outcomes (1)

  • Acute Hangover Severity Scale (AHSS)

    AHSS is a 12-item alcohol hangover measurement tool recommended for application in hangover research with a predictive validity of 92.4 %, significantly higher than that of other hangover scales (Penning et al., 2012). Alcohol hangover was measured thrice the day after drinking; in the morning immediately after waking up, at midday, and in the afternoon. The individual participant assessed his or her own hangover the day after.

    Baseline

Secondary Outcomes (3)

  • Number of drinks

    Baseline

  • Acute Hangover Severity Scale (AHSS) 2

    after 4 hours

  • Acute Hangover Severity Scale (AHSS) 3

    after 8 hours

Study Arms (2)

single type

EXPERIMENTAL

Restricted to drinking only one type of alcohol

Dietary Supplement: Single type alcohol

mixed type

ACTIVE COMPARATOR

Drinking and mixing different types of alcohols freely

Dietary Supplement: Mixing alcohol

Interventions

Mixing alcoholDIETARY_SUPPLEMENT

Alcoholic beverages, different types

Also known as: Ethanol
mixed type
Single type alcoholDIETARY_SUPPLEMENT

Alcoholic beverages, different types

Also known as: Ethanol
single type

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written and oral consent
  • minimum 18 years old
  • participating in Danish Health Research Retreat in Turkey 2016
  • will consume alcoholic beverages

You may not qualify if:

  • underage
  • will not consume alcoholic beverages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alcohol-Related Disorders

Interventions

EthanolSarcoglycans

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsDystrophin-Associated ProteinsMuscle ProteinsContractile ProteinsProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsMembrane Glycoproteins

Study Officials

  • Ole G Christiansen, MD

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2018

First Posted

April 24, 2018

Study Start

May 20, 2016

Primary Completion

May 30, 2016

Study Completion

January 31, 2018

Last Updated

April 24, 2018

Record last verified: 2018-04