Metabolic Effects of One-weak Heavy Drinking (ROSMET)

January 12, 2020 updated by: Filip Krag Knop, University Hospital, Gentofte, Copenhagen

Metabolic Effects of One-Week Heavy Drinking and Fast Food Intake During Roskilde Festival in Young Healthy Male Adults

Examination of the effect of one week's unhealthy lifestyle on glucose metabolism and liver parameters in a group of young, healthy males participating in Roskilde Festival 2016.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Metabolic effects of intermittent unhealthy lifestyle in otherwise young healthy adults are poorly studied. The investigators evaluated the effect of one week's unhealthy lifestyle on glucose metabolism and liver parameters in a group of young, healthy males participating in Roskilde Festival 2016.

Festival participants were studied before and after participation (one week) in Roskilde Festival 2016 and matched with controls who lead a normal life for an equivalent period of time. An oral glucose tolerance test (OGTT), abdominal ultrasound and strain elastography for liver stiffness were performed together with a bioimpedance scan and cognitive tests.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • BMI of 18,5-25 kg/m2
  • Normal liver function (assessed by ASAT, ALAT, GGT, alkaline phosphatase, albumin and bilirubin, coagulation factors II, VII and X, INR and platelets)

Exclusion Criteria:

  • Planning alcohol withdrawal or dieting/a special low-fat diet during Roskilde Festival
  • Diabetes or pre-diabetes
  • First degree relatives with diabetes
  • Kidney disease (eGFT<60 ml/min and/or albuminuria)
  • Chronic diseases (in addition to those already mentioned) that could affect participation in festival activities (concerts and parties)
  • Any condition in which the investigator believed would make it impossible to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control subjects
1 week of normal daily life and only by the National Health Board recommendated alcohol consumption.
Experimental: Festival subjects
1 week's participation in Roskilde Festival 2016
Behavioral: Festival participation
One week's participation in Roskilde Festival 2016 or living a normal daily life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impairment of glucose tolerance
Time Frame: First day after intervention week
Evaluated by OGTT
First day after intervention week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatic steatosis
Time Frame: First day after intervention week
Evaluated by abdominal ultrasound scan
First day after intervention week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Altered cognitive function
Time Frame: First day after intervention week
Evaluated by validated cognitive test ("SCIP")
First day after intervention week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Investigators

  • Principal Investigator: Filip K Knop, Prof,MD,PhD, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

July 4, 2016

Study Completion (Actual)

July 4, 2016

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 12, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 12, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-15019685

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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