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 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 trial start date
01/05/2001
Overall trial end date
31/08/2001
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/16287499
Publication citations
-
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.