Micronutrient Supplementation and Incidence of Common Cold

Not Applicable

Completed

• Conditions: Immune System Diseases
• Interventions: Dietary Supplement: vitamines and minerals; Dietary Supplement: placebo

• Registration Number: NCT02119143
• Lead Sponsor: Green Beat

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)

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-17
• Study First Submitted QC: 2014-04-17
• Study First Posted: 2014-04-21
• Primary Completion: 2017-01
• Study Completion: 2017-02
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-29
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamines and minerals	vitamines and minerals	41 middel aged subjects receive vitamin and mineral supplementation
cellulose	placebo	41 middle aged subjects get the placebo

Primary Outcome Measures

Name	Time	Method
Incidence of common cold	24 weeks	vitamins and minerals might influence the incidence of common cold in middle aged management employees

Secondary Outcome Measures

Name	Time	Method
change in immune markers	24 weeks	cytokine levels and expression of cytokine receptors in leucocytes may change over time due to micronutrient intervention

Trial Locations

Locations (1)

Institute of Pathophysiology and Immunology; 🇦🇹 Graz, Styria, Austria