Effects of moderate red wine consumption on antioxidant and redox-sensitive immunological parameters in healthy volunteers

ISRCTN	ISRCTN68505294
DOI	https://doi.org/10.1186/ISRCTN68505294
Protocol serial number	N/A
Sponsor	Institute for Molecular Biotechnology (Germany)
Funders	German Wine Academy (Deutsche Weinakademie) (Germany) - Funding, Landesgraduiertenfoerderung Nordrheinwestfalen (Germany) - Scholarship, Friedrich-Ebert-Stiftung (Germany) - Scholarship, Staatliche Weinbaudomaene Marienthal (Germany) - Wine

Submission date: 27/04/2005
Registration date: 09/05/2005
Last edited: 15/02/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Roland Goerlich
Scientific

Institute for Molecular Biotechnology
RWTH Aachen University
Worringerweg 1
Aachen
52074
Germany

Phone	+49 (0)241 8026627
Email	goerlich@molbiotech.rwth-aachen.de

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval received from the ethics committee of the University of Bonn.
Health condition(s) or problem(s) studied	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
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)
Key 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
Completion date	31/08/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	105
Key inclusion criteria	Healthy, normal-weight male and female subjects between 18 and 50 years of age.
Key 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)
Date of first enrolment	01/05/2001
Date of final enrolment	31/08/2001

Locations

Countries of recruitment

Germany

Study participating centre

Institute for Molecular Biotechnology

Aachen
52074
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	14/11/2005		Yes	No