Condition category
Not Applicable
Date applied
27/04/2005
Date assigned
09/05/2005
Last edited
15/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Roland Goerlich

ORCID ID

Contact details

Institute for Molecular Biotechnology
RWTH Aachen University
Worringerweg 1
Aachen
52074
Germany
+49 (0)241 8026627
goerlich@molbiotech.rwth-aachen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Moderate consumption of red wine shows antioxidant activity in vivo and modulates functions of the specific and unspecific immune response. The effects of native and dealcoholised red wine are compared to control intervention (short term: water; dietary intervention: no study drink).

Ethics approval

Ethics approval received from the ethics committee of the University of Bonn.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Oxidative stress in healthy subjects

Intervention

1. One single dose (one glass) of red wine, dealcoholised red wine or water in a fasting state (Single dose analysis) OR
2. One glass of red wine, dealcoholised red wine or no special drink (controls) daily after dinner for a period of 6 weeks (dietary intervention trial)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Concentration of total phenolic compounds in plasma (folin assay)
2. Deoxyribonucleic acid (DNA) strand breaks in peripheral leukocytes (single cell gel electrophoresis)
3. Antioxidant capacity in plasma (trolox equivalent antioxidant capacity)
4. Apoptosis of PHA activated T lymphocytes (annexin-V binding test)
5. Phagocytosis in monocytes and granulocytes (Phagotest® test kit)
6. Respiratory burst in monocytes and granulocytes (Bursttest® test kit)

Secondary outcome measures

1. Vitamin C concentration in plasma a-tocopherol concentration in serum (dietary intervention trial only)
2. Concentration of uric acid, albumin and bilirubin in plasma

Overall trial start date

01/05/2001

Overall trial end date

31/08/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy, normal-weight male and female subjects between 18 and 50 years of age.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

105

Participant exclusion criteria

1. Pregnancy and lactation: women not taking oral contraceptives underwent a pregnancy test to exclude an unknown pregnancy before starting the intervention
2. Known diseases of the liver and pancreas or dysfunctions of the gastro-intestinal tract associated with maldigestion or malabsorption
3. Hypertension
4. Dysfunctions of the lipid metabolism
5. Hyperuricaemia/gout
6. Kidney dysfunctions
7. Autoimmune diseases
8. Diabetes mellitus type I or type II
9. Acute infectious diseases
10. Eating disorders
11. Allergy to hen's eggs (albumen used as finings in red wine)
12. Alcohol abuse (more than 40 g/day) or previous addiction to alcohol
13. Drug abuse
14. Tobacco smoking during the last 6 months prior to the study
15. Regular intake of pharmaceuticals, which influence the immune system and/or the antioxidant capacity in plasma (anti-inflammatory drugs including cortisol containing medications, immune stimulants) as well as intake of drugs which might cause adverse affects by interacts with alcohol
16. Intake of nutritional supplements e.g. multivitamins, supplements containing vitamin A, C and/or vitamin E, fish oil or red wine preparations, bioactive concentrates
17. Excessive exercising (competitive athletes) defined as greater than 10 hours strenous exercise per week
18. Limited contractual capability
19. Every other state opposed to participation in the study stated by the medical supervisor
20. Participation in any other clinical trial (ongoing or completed less than 30 days prior to the present study)

Recruitment start date

01/05/2001

Recruitment end date

31/08/2001

Locations

Countries of recruitment

Germany

Trial participating centre

Institute for Molecular Biotechnology
Aachen
52074
Germany

Sponsor information

Organisation

Institute for Molecular Biotechnology (Germany)

Sponsor details

RWTH Aachen University
Worringerweg 1
Aachen
52074
Germany

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

German Wine Academy (Deutsche Weinakademie) (Germany) - Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Landesgraduiertenfoerderung Nordrheinwestfalen (Germany) - Scholarship

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Friedrich-Ebert-Stiftung (Germany) - Scholarship

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Staatliche Weinbaudomaene Marienthal (Germany) - Wine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/16287499

Publication citations

  1. Results

    Arendt BM, Ellinger S, Kekic K, Geus L, Fimmers R, Spengler U, Müller WU, Goerlich R, Single and repeated moderate consumption of native or dealcoholized red wine show different effects on antioxidant parameters in blood and DNA strand breaks in peripheral leukocytes in healthy volunteers: a randomized controlled trial (ISRCTN68505294)., Nutr J, 2005, 4, 33, doi: 10.1186/1475-2891-4-33.

Additional files

Editorial Notes