Micronutrient Supplementation and Incidence of Common Cold
This trial is active, not recruiting.
|Condition||immune system diseases|
|Treatments||vitamines and minerals, placebo|
|Collaborator||Medical University of Graz|
|Start date||April 2014|
|End date||October 2016|
|Trial size||82 participants|
|Trial identifier||NCT02119143, 26-151 ex 13/14|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Incidence of common cold
time frame: 24 weeks
change in immune markers
time frame: 24 weeks
Male or female participants from 25 years up to 50 years old.
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
|Official title||Influence of Micronutrient Supplementation on Duty Days Lost Due to Flu/Common Cold, Immune System, Oxidative Stress and Wellbeing in a Cohort of Middle Management Employees|
|Principal investigator||Manfred Lamprecht, Prof|
|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)|
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