This trial is active, not recruiting.

Condition immune system diseases
Treatments vitamines and minerals, placebo
Sponsor Green Beat
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
(Active Comparator)
41 middel aged subjects receive vitamin and mineral supplementation
vitamines and minerals
given for 24 weeks, after 4 week wash out of all supplements and dietetic products
(Placebo Comparator)
41 middle aged subjects get the placebo
given for 24 weeks, after 4 weeks wash out of all supplements and dietetic products

Primary Outcomes

Incidence of common cold
time frame: 24 weeks

Secondary Outcomes

change in immune markers
time frame: 24 weeks

Eligibility Criteria

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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Green Beat.