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Completed

NCT Number: NCT02119143

Micronutrient Supplementation and Incidence of Common Cold

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.

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Key information

Conditions

Immune System Diseases Common Cold Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Pathophysiology and Immunology

Graz, Styria, 8010, Austria

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vitamines and minerals

Dietary Supplement

given for 24 weeks, after 4 week wash out of all supplements and dietetic products

Placebo

Dietary Supplement

given for 24 weeks, after 4 weeks wash out of all supplements and dietetic products

Primary outcomes

  1. Incidence of common cold

    Time frame: 24 weeks

    vitamins and minerals might influence the incidence of common cold in middle aged management employees

Secondary outcomes

  1. change in immune markers

    Time frame: 24 weeks

    cytokine levels and expression of cytokine receptors in leucocytes may change over time due to micronutrient intervention

Other outcomes

  1. change in redox biology

    Time frame: 24 weeks

    micronutrients may influence redox biology of subjects

Sponsors and collaborators

Lead sponsor

Green Beat

Other

Collaborators

  • Medical University of Graz

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 21, 2014
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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