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

Completed

• Conditions: Oxidative stress in healthy subjects; Not Applicable

• Registration Number: ISRCTN68505294
• Lead Sponsor: Institute for Molecular Biotechnology (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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