Micronutrient Supplementation and Incidence of Common Cold

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Immune System Diseases

Intervention / Treatment
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* Dietary Supplement: vitamines and minerals
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamines and minerals<br>41 middel aged subjects receive vitamin and mineral supplementation | Dietary Supplement: vitamines and minerals<br>* given for 24 weeks, after 4 week wash out of all supplements and dietetic products<br>|
| Placebo Comparator: cellulose<br>41 middle aged subjects get the placebo | Dietary Supplement: placebo<br>* given for 24 weeks, after 4 weeks wash out of all supplements and dietetic products<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of common cold | vitamins and minerals might influence the incidence of common cold in middle aged management employees | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in immune markers | cytokine levels and expression of cytokine receptors in leucocytes may change over time due to micronutrient intervention | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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common cold, immunity, oxidative stress