Micronutrient Supplementation and Incidence of Common Cold

July 29, 2017 updated by: Lamprecht Manfred PhD, PhD, Green Beat

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8010
        • Institute of Pathophysiology and Immunology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of common cold
Time Frame: 24 weeks
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
Time Frame: 24 weeks
cytokine levels and expression of cytokine receptors in leucocytes may change over time due to micronutrient intervention
24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in redox biology
Time Frame: 24 weeks
micronutrients may influence redox biology of subjects
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Beat

Collaborators

Medical University of Graz

Investigators

  • Principal Investigator: Manfred Lamprecht, Prof, Green Beat and Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 29, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-151 ex 13/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Immune System Diseases

Clinical Trials on vitamines and minerals

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe