Immune System Diseases
Conditions
Keywords
common cold, immunity, oxidative stress
Brief summary
This study investigates the effects of a dietary supplement - a cocktail of vitamins and minerals - on the incidence of common cold in a cohort of middle management employees.The primary outcome is defined as the number of duty days lost due to common cold/flu. Further, immune parameters and markers of redox biology/oxidative stress will be determined. The wellbeing in the cohort will be evaluated via questionnaires.
Detailed description
randomized, double-blinded, placebo controlled trial 82 Subjects, men and women, 25 - 50 yrs, non-smokers, employees of middle management, 24 weeks of supplementation/placebo, 4 wk wash-out of all supplements and dietetic products, undersupply of fruit, vegetables (\< 4 portions/day) and whole grain food (\< 5x/wk)
Interventions
given for 24 weeks, after 4 week wash out of all supplements and dietetic products
given for 24 weeks, after 4 weeks wash out of all supplements and dietetic products
Sponsors
Study design
Eligibility
Inclusion criteria
* pre or peri-menopausal * non-smokers * sedentary or moderately trained * BMI: \>20 and \< 35kg/m2 * undersupply of fruits, vegetables and whole grain food, fibres * contraceptives * wash-out
Exclusion criteria
* post-menopausal * smokers * trained people * BMI out of inclusion range * adequate intake of vegetables, fruits and whole grain food, fibres * no adherence to wash-out
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of common cold | 24 weeks | vitamins and minerals might influence the incidence of common cold in middle aged management employees |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in immune markers | 24 weeks | cytokine levels and expression of cytokine receptors in leucocytes may change over time due to micronutrient intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| change in redox biology | 24 weeks | micronutrients may influence redox biology of subjects |
Countries
Austria