NCT00764426

Brief Summary

Effect of moderate alcohol consumption in form of red wine, beer and ethanol solution and corresponding de-alcoholised beverages on immune measures.

  • In healthy middle aged men and women
  • In a randomized controlled cross-over trial
  • Two intervention periods over 3 weeks

Trial Health

80
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2004

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2008

Completed
Last Updated

October 2, 2008

Status Verified

October 1, 2008

First QC Date

September 30, 2008

Last Update Submit

October 1, 2008

Conditions

ArteriosclerosisMyocardial Infarction

Keywords

alcoholic beveragesnon-alcoholic beveragesinflammationSerum concentration of inflammatory markers before and after intervention

Outcome Measures

Primary Outcomes (1)

  • Concentration of inflammatory markers including C-reactive protein

    12 weeks

Secondary Outcomes (1)

  • Ex vivo migration of monocytes

    6 weeks

Study Arms (2)

non-alcoholic beverages

ACTIVE COMPARATOR

dealcoholised red wine, de-alcoholised beer, water

Drug: de-alcoholised red wine, de-alcoholised beer, water

alcoholic beverages

ACTIVE COMPARATOR

red wine, beer, ethanol

Drug: red wine, beer, ethanol

Interventions

red wine, beer, ethanolDRUG

Alcoholic beverages equivalent to 30g of alcohol per day for men and 20g/d for women for 3 weeks

alcoholic beverages
de-alcoholised red wine, de-alcoholised beer, waterDRUG

de-alcoholised red wine, de-alcoholised beer, water

non-alcoholic beverages

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • non-smoker
  • healthy

You may not qualify if:

  • personal or family history of dependency
  • any chronic disease
  • acute and chronic inflammatory processes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ulm, Medical Center

Ulm, 89081, Germany

Location

Related Publications (1)

  • Imhof A, Blagieva R, Marx N, Koenig W. Drinking modulates monocyte migration in healthy subjects: a randomised intervention study of water, ethanol, red wine and beer with or without alcohol. Diab Vasc Dis Res. 2008 Mar;5(1):48-53. doi: 10.3132/dvdr.2008.009.

    PMID: 18398813RESULT

MeSH Terms

Conditions

ArteriosclerosisMyocardial InfarctionInflammation

Interventions

BeerEthanolWater

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Alcoholic BeveragesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented BeveragesFermented FoodsFood and BeveragesAlcoholsOrganic ChemicalsHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Armin P Imhof, MD

    University of Ulm, Medical Center, Ulm, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 2, 2008

Study Start

June 1, 2004

Last Updated

October 2, 2008

Record last verified: 2008-10

Locations

DE(1)