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Effects of moderate red wine consumption on antioxidant and redox-sensitive immunological parameters in healthy volunteers
ISRCTN ISRCTN68505294
DOI 10.1186/ISRCTN68505294
ClinicalTrials.gov identifier
EudraCT number
Public title Effects of moderate red wine consumption on antioxidant and redox-sensitive immunological parameters in healthy volunteers
Scientific title
Acronym N/A
Serial number at source N/A
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).
Lay summary
Ethics approval Ethics approval received from the ethics committee of the University of Bonn.
Study design Randomised controlled trial
Countries of recruitment Germany
Disease/condition/study domain Oxidative stress in healthy subjects
Participants - inclusion criteria Healthy, normal-weight male and female subjects between 18 and 50 years of age.
Participants - 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)
Anticipated start date 01/05/2001
Anticipated end date 31/08/2001
Status of trial Completed
Patient information material
Target number of participants 105
Interventions 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)
Primary outcome measure(s) 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 measure(s) 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
Sources of funding 1. German Wine Academy (Deutsche Weinakademie) (Germany) - Funding
2. Landesgraduiertenfoerderung Nordrheinwestfalen (Germany) - Scholarship
3. Friedrich-Ebert-Stiftung (Germany) - Scholarship
4. Staatliche Weinbaudomaene Marienthal (Germany) - Wine
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/16287499
Contact name Prof  Roland  Goerlich
  Address Institute for Molecular Biotechnology
RWTH Aachen University
Worringerweg 1
  City/town Aachen
  Zip/Postcode 52074
  Country Germany
  Tel +49 (0)241 8026627
  Fax +49 (0)241 8022148
  Email goerlich@molbiotech.rwth-aachen.de
Sponsor Institute for Molecular Biotechnology (Germany)
  Address RWTH Aachen University
Worringerweg 1
  City/town Aachen
  Zip/Postcode 52074
  Country Germany
Date applied 27/04/2005
Last edited 15/02/2008
Date ISRCTN assigned 09/05/2005
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