Micronutrient Supplementation and Incidence of Common Cold

Immune System Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119143
• Other study ID #: 26-151 ex 13/14
• Status: Completed
• Phase: N/A
• First received: April 17, 2014
• Last updated: July 29, 2017
• Start date: April 2014
• Est. completion date: February 2017

Study information

• Verified date: July 2017
• Source: Green Beat
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

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

Related Conditions & MeSH terms

• Common Cold
• Immune System Diseases

Intervention

Dietary Supplement:
• vitamines and minerals
given for 24 weeks, after 4 week wash out of all supplements and dietetic products
• placebo
given for 24 weeks, after 4 weeks wash out of all supplements and dietetic products

Locations

Country	Name	City	State
Austria	Institute of Pathophysiology and Immunology	Graz	Styria

Sponsors (2)

Lead Sponsor	Collaborator
Green Beat	Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in redox biology	micronutrients may influence redox biology of subjects	24 weeks
Primary	Incidence of common cold	vitamins and minerals might influence the incidence of common cold in middle aged management employees	24 weeks
Secondary	change in immune markers	cytokine levels and expression of cytokine receptors in leucocytes may change over time due to micronutrient intervention	24 weeks