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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Institute for Molecular Biotechnology
RWTH Aachen University
Worringerweg 1
Aachen
52074
Germany
| Phone | +49 (0)241 8026627 |
|---|---|
| goerlich@molbiotech.rwth-aachen.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/05/2001 |
| Completion date | 31/08/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
52074
Germany
Sponsor information
Institute for Molecular Biotechnology (Germany)
Research organisation
Research organisation
RWTH Aachen University
Worringerweg 1
Aachen
52074
Germany
Funders
Funder type
Research organisation
German Wine Academy (Deutsche Weinakademie) (Germany) - Funding
No information available
Landesgraduiertenfoerderung Nordrheinwestfalen (Germany) - Scholarship
No information available
Friedrich-Ebert-Stiftung (Germany) - Scholarship
No information available
Staatliche Weinbaudomaene Marienthal (Germany) - Wine
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
